PharmacokineticsPhase 1NCT06921590
A Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects
A Phase 1 study testing AL001 and Lithium Carbonate Capsule in people with Pharmacokinetics and Neurology, run by Alzamend Neuro, Inc. at 1 site in United States.
Trial summary
The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Pharmacokinetics, Neurology
- What is being tested?
- AL001 and Lithium Carbonate Capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2025to 15 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy subjects ≥18 and <65 years old in reasonably good physical and psychological health as determined by the Investigator's review of medical and surgical history, physical examination (including neurological examination), 12-lead ECG, vital signs, and clinical laboratory tests.
- Assessment of subject's mental health status will be conducted to avoid enrolling subjects who are on the verge of a manic or depressive episode. Affective stability, defined by a Young Mania Rating Scale (YMRS) rating of <8 and a Hamilton Depression Rating Scale (HRSD-17) rating of ≤7 at screening and baseline. Assessment of subject's suicidal ideation and behavior (SI/B) using the Columbia-Suicide Severity Rating Scale (C SSRS) will be conducted to avoid enrolling subjects with concerning results, defined as a lifetime history of a suicide attempt, past year level 4 or higher suicidal ideation on the C-SSRS, or past month suicidal ideation of any kind. The "Lifetime/Recent" version will be used at screening and the "Since Last Visit" version will be used subsequently.
- Able to understand and follow instructions during the study as determined by the Investigator.
- Willing to follow study procedures.
- Willing and able to adhere to study restrictions and to be confined at the clinical research center per protocol requirements.
- Any gender, race, or ethnicity.
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- Able to understand and provide written informed consent.
- Males (non-vasectomized and vasectomized) must agree to use barrier contraception during the study until after Treatment Period 2 in-clinic follow-up visit on Day 23 (P2).
- Females must meet one the of the following criteria:
- Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:
- Abstinence from heterosexual intercourse from the Screening visit through to at least 30 days after the last dose of the second study drug on Day 14 (P2).
- One of the following highly-effective contraceptive methods, used from at least 28 days prior to the Screening visit through to at least 30 days after the last dose of the second study drug on Day 14 (P2).
- i. Systemic contraceptives (combined birth control pills, injectable/implant/ insertable hormonal birth control products, or transdermal patch).
- ii. Intrauterine device (with or without hormones).
- iii. Male partner vasectomized at least 6 months prior to the Screening visit.
- One of the following double-barrier contraceptive methods, used from the Screening visit through to at least 30 days after the last dose of the second study drug on Day 14 (P2):
- i. Male condom used simultaneously with diaphragm plus spermicide.
- ii. Male condom used simultaneously with cervical cap plus spermicide.
- Or
- Is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation), or is in a postmenopausal state (i.e., at least 1 year without menses prior to the Screening visit).
- Able to communicate in English, including speaking, reading, and writing.
- Body mass index (BMI) within 18.0 to 30.0 kg/m2, inclusive, and body weight of at least 50 kg at the time of Screening.
- ECG recording, after at least 5 minutes of rest in a supine position without clinically significant abnormalities as determined by the Investigator.
Who cannot join
- Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings, or clinical laboratory findings (as determined by the Investigator) that may affect the safety or successful participation of the subject. Specifically, evidence of clinically significant hematological, renal, endocrine, pulmonary, cardiovascular, dermatologic, muscular, or allergic disease or disorder (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) that may affect the safety or successful participation of the subject. Any history of drug hypersensitivity, asthma (with the exception of childhood asthma), urticaria or other severe allergic diathesis.
- Presence or history of any disorder that may prevent the successful completion of the study.
- Other severe acute, chronic, or historical medical or psychiatric condition or laboratory abnormality or social circumstance that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- History of seizure disorder and/or severe head trauma (other than a single childhood febrile seizure).
- History or presence of gastrointestinal disease including chronic gastritis, peptic ulcers, inflammatory bowel disease, hemorrhagic gastritis, or duodenitis.
- History or presence of acute or chronic liver disease as determined by the Investigator.
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- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the study treatments.
- Any history of frequent headache or migraine.
- Kidney disease (eGFR <60 mL/minute/1.73 m2).
- Uncontrolled tachy/brady arrhythmias, atrial fibrillation, or coronary heart failure.
- Systemic related exclusions:
- Active cancer (except squamous cell and basal skin cancers) requiring chemo- or radiation therapy.
- Positive test results for HIV, HBV, or HCV (unless quantitative PCR negative for HCV) at Screening.
- Uncontrolled hypertension with a sustained blood pressure >160/100 mmHg at Screening, or at check-in on Day -1 (P1).
- Fever (body temperature >101.4°F [38.5°C]), acute upper respiratory, or any other infections at Screening, or at check-in on Day -1 (P1).
- Psychiatric or neurological illnesses (e.g., depression, schizophrenia or other psychotic syndromes, Parkinson's disease and related movement disorders, seizure disorder, and myasthenia gravis).
- Treatment with haloperidol, antipsychotics, monoamine oxidase inhibitors, neuromuscular blocking agents. Subjects who have ever received immunosuppressant treatment (excluding topical or oral corticosteroids taken 1 and 5 years before Screening, respectively).
- Current and during Lithium treatment hyponatremia, defined as serum sodium laboratory value outside the standard reference range.
- The use of any medication on a chronic basis with the exception of hormonal contraceptives for females of childbearing potential. An appropriate drug free period will be required for prescription or over the counter (OTC) drugs to washout, particularly of any especially long half-life drugs (see exclusion criteria 16 and 17 below for relevant details).
- The use of any medication (OTC, prescription medication, vitamins, and herbal supplements) within 14 days prior to the Screening visit and 14 days prior to Day -1 (P1) - or at least 6 times the respective elimination half-life rather than 14 days, whichever is longer - through the completion of the second study drug treatment on Day 14 (P2). Contraception may be continued. Acetaminophen may be concomitantly used at the discretion of the Investigator (up to 1000 mg TID). Non-medicated opthalmic products (for lubrication and comfort) may also be permitted at the discretion of the Investigator.
- Prescribed or OTC use of a salicylate-containing product other than low dose aspirin for cardioprotection (e.g., aspirin, magnesium salicylate, bismuth sub-salicylate, salicylazosulfapyridine [sulfasalazine]) from 1 week before first dose of the first study drug on Day 1 (P1) to 1 week after last dosing of the second study drug on Day 14 (P2); any other prescribed anticoagulant medication. (Section 5.7.10).
- Unwilling to refrain from consumption of poppy seeds or quinine (tonic water) 48 hours prior to check-in on Day -1 (P1) and throughout the course of the study.
- Aspirin/nasal polyposis/asthma syndrome.
- Female who is breastfeeding.
- Female who is pregnant according to the pregnancy test at Screening or prior to the first dosing of the first study drug on Day 1 (P1); female planning to become pregnant during the study.
- History of adverse or hypersensitivity reaction to lithium, aspirin, salicylate, L-proline, or any investigational or reference article excipient.
- Drug/alcohol abuse:
- History of drug abuse (barbiturate, amphetamine, benzodiazepine, cocaine, opiates and cannabis) within the last 12 months or a positive urine drug screen at Screening or Day -1 (P1).
- Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements or positive ethanol (alcohol) test at Screening or Day -1 (P1).
- More than moderate current alcohol consumption. Subjects will be advised to consume no more than 2 units of alcohol per day and completely abstain from 72 hours prior to any visit (1 unit is equal to approximately 10 g of pure alcohol, [250 mL] of beer [5%], 1 small glass [100 mL] of wine [12%], or 35 mL of spirits [35%]).
- Demonstrating excess xanthine consumption (e.g., ingests more than 5 cups of coffee or equivalent per day). Also, subject is not willing to refrain from xanthine products for 48 hours prior to check-in on Day -1 (P1) until discharge from Period 2 treatment on Day 15 (P2). The subject is not willing to refrain from grapefruit, pomelo, Seville orange products or juice within 14 days prior to check-in on Day -1 (P1) until discharge from Period 2 treatment on Day 15 (P2). Exceptions may be made on a case-by-base basis following agreement by the Principal Investigator and the Sponsor.
- Participation in a clinical trial and receipt of an investigational medication within 30 days or 5 half-lives (if known), whichever is greater, prior to the first dose of the current study drug.
- History of untreated thyroid dysfunction (due to potential lithium drug-disease interaction).
- Screening MRI-related exclusion criteria: intracranial mass, evidence of other anatomical findings that might affect safety or causes of cognitive/behavioral impairment as assessed by a qualified neurologist. Subjects must not have any implantable medical device (e.g., aneurysm clip, vagus nerve stimulator, cardiac pacemaker) or be reliant on a non-removable medical device (e.g., insulin pump) unless that device is certified as MRI compatible. Known intolerability to MRI neuroimaging procedures.
- Subjects with any past apparent suicide attempt or suicidal behavior, including those with a lifetime history of suicide attempt(s) or a past year level 4 or higher SI/B or past month SI/B (C-SSRS) of any kind.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: A Randomized, Balanced, Phase 1, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects
The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers. The main questions this study aims to answer are:
How safe and effective is AL001 when compared to Lithium Carbonate? How is AL001 broken down in the brain and body compared to Lithium Carbonate?
Participants will be asked to:
- Take both the study drug (AL001) and Lithium Carbonate each for a period of 14 days
- Stay overnight at MGH's research unit for two separate 2-week periods
- Participate in two separate 24 hour periods of multiple MRIs and blood draws
Read the detailed description
This study is researching the effects of a new type of crystalized lithium, AL001, on it's ability to reach the brain and have an effect. The investigators will be comparing this to a commonly used type of lithium, lithium carbonate. Investigators want to see if the crystalized lithium can have the same or better effect when compared to lithium carbonate. Past research has shown a greater effect within the body with crystalized lithium when compared to commonly used lithium.
This past research suggests that crystallized lithium may be more effective, potentially allowing for lower doses and fewer side effects. If successful, this new form of lithium could offer a new and safe treatment option for psychiatric and neurological disorders.
This study involves two, 2-week long overnight stays at the main campus of Massachusetts General Hospital. During these stays participants will receive lithium carbonate for one stay and the crystalized lithium for the other. There are frequent blood draws and brain MRI scans during two periods of the study to look at how the crystalized lithium is broken down in the body and to see how it reaches the brain. This study will compare AL001 to a study reference treatment of lithium carbonate. The majority of the blood draws and MRIs will occur over a 24 hour period during each 2-week long overnight stay at MGH.
- Conditions
- Pharmacokinetics, Neurology
- Being tested
- AL001, Lithium Carbonate Capsule
- Keywords
- Healthy Controls
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL001Drug
Also called lithium salicylate/L-proline cocrystal
Crystalized Lithium
Lithium Carbonate CapsuleDrug
Lithium Carbonate
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: AL001 then Lithium Carbonate | Other | Participants take 1050 mg of AL001 TID for 14 days then after a washout period, take 150 mg TID of Lithium Carbonate for 14 days. Receives: Drug: AL001; Drug: Lithium Carbonate Capsule |
| Sequence 2: Lithium Carbonate then AL001 | Other | Participants take 150 mg of Lithium Carbonate TID for 14 days, then after a washout period, take 1050 mg of AL001 TID for 14 days. Receives: Drug: AL001; Drug: Lithium Carbonate Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule.
- Brain (and brain structures)-to-plasma ratios between AL001 and lithium carbonate for steady-state PK measures/ parameters.
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state
To evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule.
Area under the plasma and brain concentration versus time curves (AUC) will be measured.
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state
To characterize AL001 lithium PK under the conditions of this study
Plasma AUCtau ss = Area under the plasma concentration versus time curve from time zero to the end of the 24-hour 3-dose interval at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state
To characterize AL001 lithium PK under the conditions of this study
Brain AUCtau ss = Area under the plasma concentration versus time curve from time zero to the end of the 24-hour 3- dose interval at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma Cmax ss = Maximum plasma concentration at steady-state.
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain Cmax ss = Maximum brain concentration at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma tmax ss = Time to reach the maximum plasma concentration at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state
To characterize AL001 lithium PK under the conditions of this study
Brain tmax ss = Time to reach the maximum brain concentration at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma Cmin ss = Minimum plasma concentration at steady-state (if at end-of-24 hour dosing interval: Ctrough
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain Cmin ss = Minimum brain concentration at steady-state (if at end-of-24 hour dosing interval: Ctrough)
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma tmin ss = Time to reach the minimum plasma concentration at steady-state over 24 hours
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain tmin ss = Time to reach the minimum brain concentration at steady-state over 24 hours
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain/Plasma AUCtau ss ratio = Ratio of brain/plasma areas under the plasma concentration versus time curve from time zero to the end of the 24-hour 3-dose interval at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain/Plasma Cmax ss ratio = Ratio of brain/plasma minimum concentrations from time zero to the end of the 24-hour 3-dose interval at steady-state.
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain/Plasma Cmin ss ratio = Ratio of brain/plasma minimum concentrations from time zero to the end of the 24-hour 3-dose interval at steady-state.
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma apparent oral clearance (CLoral) = Dose24 hours/Plasma AUCtau ss
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Average plasma concentration at steady-state (Css ave plasma) = Plasma 24 h AUCtau ss/24 hours
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Average brain concentration at steady-state (Css ave brain) = Brain 24 h AUCtau ss/24 hours
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma degree of fluctuation at steady-state (FIplasma ss) = Ratio of plasma (Cmax ss - Cmin ss) to Css ave plasma
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain degree of fluctuation at steady-state (FIbrain ss) = Ratio of brain 24 h (Cmax ss - Cmin ss) to Css ave brain
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma swing 24 h = [(Cmax ss - Cmin ss)/ Cmin ss ]
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain swing 24 h = [(Cmax ss - Cmin ss)/ Cmin ss ]
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
MRT oral doses (0-24h ss) = Mean Residence Time following oral doses at steady-state (0 to tau, end of 24-hour dosing interval)
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with adverse events and serious adverse events
Measured: From enrollment to end of follow-up period at Day 42(P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with abnormal vital signs
Measured: From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with abnormal values and change from baseline reading for each ECG parameter. Individual parameters including heart rate, PR, QT, QTcF, QRS, and RR intervals will be collected.
Measured: From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with abnormal findings on physical exam.
Measured: From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with abnormal values and changes from baseline for each Safety laboratory test (standard hematology, blood chemistry [clinical chemistry], urinalysis, and pregnancy test [for females of childbearing potential only).
Measured: From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with prevalence of plasma lithium concentrations above 1.2 mEq/L
Measured: From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with prevalence of plasma salicylic acid concentrations above 30 mg/dL
Measured: From enrollment to Day 23 (P2)
Secondary outcomes (11)
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma AUCtau ss = Area under the plasma concentration versus time curve from time zero to the end of the 24-hour 3-dose interval at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma Cmax ss = Maximum plasma concentration at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma tmax ss = Time to reach the maximum plasma concentration at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma Cmin ss = Minimum plasma concentration at steady-state (if at end-of-24 hour dosing interval: Ctrough)
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma tmin ss = Time to reach the minimum plasma concentration at steady-state over 24 hours
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma apparent oral clearance (CLoral) = Dose24 hours/Plasma AUCtau ss
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Average plasma concentration at steady-state (Css ave plasma) = Plasma 24 h AUCtau ss/24 hours
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma degree of fluctuation at steady-state (FIplasma ss) = Ratio of plasma (Cmax ss - Cmin ss) to Css ave plasma
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma swing 24 h = [(Cmax ss - Cmin ss)/ Cmin ss ]
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
MRT oral doses (0-24h ss) = Mean Residence Time following oral doses at steady-state (0 to tau, end of 24-hour dosing interval)
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
Exploring Brain Pharmacodynamics using Magnetic Resonance Spectroscopy
Magnetic resonance spectroscopy (MRS) techniques will be applied to explore brain metabolism, including possible metabolic similarities/differences between treatments
Measured: From Screening (Day 1) to Day 23 (P2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start9 May 2025
- Primary completion15 Dec 2025
- Study completion15 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alzamend Neuro, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06921590
- Sponsor's protocol ID
- AL001-ALZ03
- Status last verified
- May 2026
- First submitted
- 19 Mar 2025
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Balanced, Phase 1, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects
- ClinicalTrials.gov ID
- NCT06921590
- Acronym / sponsor ID
- AL001-ALZ03
- Conditions
- Pharmacokinetics, Neurology
- Keywords
- Healthy Controls
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Alzamend Neuro, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Study start
- 9 May 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 15 Dec 2025 (actual)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers. The main questions this study aims to answer are:
How safe and effective is AL001 when compared to Lithium Carbonate? How is AL001 broken down in the brain and body compared to Lithium Carbonate?
Participants will be asked to:
- Take both the study drug (AL001) and Lithium Carbonate each for a period of 14 days
- Stay overnight at MGH's research unit for two separate 2-week periods
- Participate in two separate 24 hour periods of multiple MRIs and blood draws
Detailed description
This study is researching the effects of a new type of crystalized lithium, AL001, on it's ability to reach the brain and have an effect. The investigators will be comparing this to a commonly used type of lithium, lithium carbonate. Investigators want to see if the crystalized lithium can have the same or better effect when compared to lithium carbonate. Past research has shown a greater effect within the body with crystalized lithium when compared to commonly used lithium.
This past research suggests that crystallized lithium may be more effective, potentially allowing for lower doses and fewer side effects. If successful, this new form of lithium could offer a new and safe treatment option for psychiatric and neurological disorders.
This study involves two, 2-week long overnight stays at the main campus of Massachusetts General Hospital. During these stays participants will receive lithium carbonate for one stay and the crystalized lithium for the other. There are frequent blood draws and brain MRI scans during two periods of the study to look at how the crystalized lithium is broken down in the body and to see how it reaches the brain. This study will compare AL001 to a study reference treatment of lithium carbonate. The majority of the blood draws and MRIs will occur over a 24 hour period during each 2-week long overnight stay at MGH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: AL001 then Lithium Carbonate | Other | Drug: AL001, Drug: Lithium Carbonate CapsuleParticipants take 1050 mg of AL001 TID for 14 days then after a washout period, take 150 mg TID of Lithium Carbonate for 14 days. |
| Sequence 2: Lithium Carbonate then AL001 | Other | Drug: AL001, Drug: Lithium Carbonate CapsuleParticipants take 150 mg of Lithium Carbonate TID for 14 days, then after a washout period, take 1050 mg of AL001 TID for 14 days. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (23 listed)
- Healthy subjects ≥18 and <65 years old in reasonably good physical and psychological health as determined by the Investigator's review of medical and surgical history, physical examination (including neurological examination), 12-lead ECG, vital signs, and clinical laboratory tests.
- Assessment of subject's mental health status will be conducted to avoid enrolling subjects who are on the verge of a manic or depressive episode. Affective stability, defined by a Young Mania Rating Scale (YMRS) rating of <8 and a Hamilton Depression Rating Scale (HRSD-17) rating of ≤7 at screening and baseline. Assessment of subject's suicidal ideation and behavior (SI/B) using the Columbia-Suicide Severity Rating Scale (C SSRS) will be conducted to avoid enrolling subjects with concerning results, defined as a lifetime history of a suicide attempt, past year level 4 or higher suicidal ideation on the C-SSRS, or past month suicidal ideation of any kind. The "Lifetime/Recent" version will be used at screening and the "Since Last Visit" version will be used subsequently.
- Able to understand and follow instructions during the study as determined by the Investigator.
- Willing to follow study procedures.
- Willing and able to adhere to study restrictions and to be confined at the clinical research center per protocol requirements.
Key exclusion criteria (35 listed)
- Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings, or clinical laboratory findings (as determined by the Investigator) that may affect the safety or successful participation of the subject. Specifically, evidence of clinically significant hematological, renal, endocrine, pulmonary, cardiovascular, dermatologic, muscular, or allergic disease or disorder (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) that may affect the safety or successful participation of the subject. Any history of drug hypersensitivity, asthma (with the exception of childhood asthma), urticaria or other severe allergic diathesis.
- Presence or history of any disorder that may prevent the successful completion of the study.
- Other severe acute, chronic, or historical medical or psychiatric condition or laboratory abnormality or social circumstance that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- History of seizure disorder and/or severe head trauma (other than a single childhood febrile seizure).
- History or presence of gastrointestinal disease including chronic gastritis, peptic ulcers, inflammatory bowel disease, hemorrhagic gastritis, or duodenitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL001Also: lithium salicylate/L-proline cocrystalCrystalized Lithium | Drug | Sequence 1: AL001 then Lithium Carbonate, Sequence 2: Lithium Carbonate then AL001 |
| Lithium Carbonate CapsuleLithium Carbonate | Drug | Sequence 1: AL001 then Lithium Carbonate, Sequence 2: Lithium Carbonate then AL001 |
Primary outcome
To evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule.
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state
• Brain (and brain structures)-to-plasma ratios between AL001 and lithium carbonate for steady-state PK measures/ parameters.
To evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule.
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state
Area under the plasma and brain concentration versus time curves (AUC) will be measured.
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state
Plasma AUCtau ss = Area under the plasma concentration versus time curve from time zero to the end of the 24-hour 3-dose interval at steady-state
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain AUCtau ss = Area under the plasma concentration versus time curve from time zero to the end of the 24-hour 3- dose interval at steady-state
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma Cmax ss = Maximum plasma concentration at steady-state.
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain Cmax ss = Maximum brain concentration at steady-state
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state
Plasma tmax ss = Time to reach the maximum plasma concentration at steady-state
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain tmax ss = Time to reach the maximum brain concentration at steady-state
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma Cmin ss = Minimum plasma concentration at steady-state (if at end-of-24 hour dosing interval: Ctrough
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain Cmin ss = Minimum brain concentration at steady-state (if at end-of-24 hour dosing interval: Ctrough)
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma tmin ss = Time to reach the minimum plasma concentration at steady-state over 24 hours
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain tmin ss = Time to reach the minimum brain concentration at steady-state over 24 hours
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain/Plasma AUCtau ss ratio = Ratio of brain/plasma areas under the plasma concentration versus time curve from time zero to the end of the 24-hour 3-dose interval at steady-state
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain/Plasma Cmax ss ratio = Ratio of brain/plasma minimum concentrations from time zero to the end of the 24-hour 3-dose interval at steady-state.
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain/Plasma Cmin ss ratio = Ratio of brain/plasma minimum concentrations from time zero to the end of the 24-hour 3-dose interval at steady-state.
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma apparent oral clearance (CLoral) = Dose24 hours/Plasma AUCtau ss
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Average plasma concentration at steady-state (Css ave plasma) = Plasma 24 h AUCtau ss/24 hours
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Average brain concentration at steady-state (Css ave brain) = Brain 24 h AUCtau ss/24 hours
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma degree of fluctuation at steady-state (FIplasma ss) = Ratio of plasma (Cmax ss - Cmin ss) to Css ave plasma
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain degree of fluctuation at steady-state (FIbrain ss) = Ratio of brain 24 h (Cmax ss - Cmin ss) to Css ave brain
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma swing 24 h = [(Cmax ss - Cmin ss)/ Cmin ss ]
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain swing 24 h = [(Cmax ss - Cmin ss)/ Cmin ss ]
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
MRT oral doses (0-24h ss) = Mean Residence Time following oral doses at steady-state (0 to tau, end of 24-hour dosing interval)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to end of follow-up period at Day 42(P2)
Proportion of participants with adverse events and serious adverse events
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to Day 23 (P2)
Proportion of participants with abnormal vital signs
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to Day 23 (P2)
Proportion of participants with abnormal values and change from baseline reading for each ECG parameter. Individual parameters including heart rate, PR, QT, QTcF, QRS, and RR intervals will be collected.
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to Day 23 (P2)
Proportion of participants with abnormal findings on physical exam.
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to Day 23 (P2)
Proportion of participants with abnormal values and changes from baseline for each Safety laboratory test (standard hematology, blood chemistry [clinical chemistry], urinalysis, and pregnancy test [for females of childbearing potential only).
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to Day 23 (P2)
Proportion of participants with prevalence of plasma lithium concentrations above 1.2 mEq/L
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to Day 23 (P2)
Proportion of participants with prevalence of plasma salicylic acid concentrations above 30 mg/dL
11 secondary outcomes
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Exploring Brain Pharmacodynamics using Magnetic Resonance Spectroscopy
Time frame: From Screening (Day 1) to Day 23 (P2)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AL001 and Lithium Carbonate Capsule in people with Pharmacokinetics and Neurology, run by Alzamend Neuro, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 35 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule. (time frame: From time zero to the end of the 24 hour 3-dose interval at steady state). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.