Healthy VolunteersPhase 1NCT04570644
Randomized I/II Phase Study of ALZT-OP1 Combination Therapy in Alzheimer's Disease and Normal Healthy Volunteers
A Phase 1 study testing ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen) in people with Healthy Volunteers and Alzheimer Disease, run by AZTherapies, Inc. at 1 site in United States.
Trial summary
This is a randomized, open-label, cross-over, pharmacokinetic and pharmacodynamic PK/PD study. (Part A)The PK portion of the study is designed to evaluate the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-administration of the two… Read more about this study
- Who is it for?
- Ages 55 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers, Alzheimer Disease
- What is being tested?
- ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Aug 2020to 18 Jan 2021
- 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 55 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- For All Subjects
- Provide a signed written informed consent;
- Age 55-79 old (inclusive);
- ECG without abnormal, clinically significant findings;
- Body mass index (BMI) ≥ 18 kg/m2 and ≤ 30 kg/m2
- Negative urine drug screen for selected drugs of abuse at screening;
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- Negative for hepatitis and HIV at screening;
- Negative for COVID-19 at screening;
- Good general health, as determined by medical history, physical examination, and clinical laboratory testing;
- Must provide written informed consent for CSF sampling. For AD Subjects Only
- In addition to satisfying all of the above inclusion criteria, AD subjects must also meet the following criteria:
- Diagnosed with mild to moderate Alzheimer's disease;
- Clinical Dementia Rating (Global) 0.5
- Mini-mental state examination (MMSE) ≤ 22;
- Must be fluent in the language of the cognitive testing material being administered;
- Stability of permitted medications for 4 weeks prior to study start;
- Visual and auditory acuity adequate for neuropsychological testing.
- Must provide written informed consent for APOe4 genotype testing; For All Subjects in Part A (PK)
- Willingness to stay in the unit overnight for the duration of the PK portion of the study.
Who cannot join
- For All Subjects
- Current smokers, or ex-smokers with a remote history (> 100 pack/year);
- Clinically significant medical conditions;
- History of abnormal clinically significant ECG abnormalities;
- Symptomatic viral infection, or suspicion thereof (including rhinitis) in the last 14 days prior to dosing;
- Signs of active pulmonary infection or other pulmonary inflammatory conditions, even in absence of febrile episodes, in the last 14 days;
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- History or presence of disease in the kidneys and/or heart, lungs, liver, gastrointestinal tract, endocrine organs or other conditions such as metabolic disease known to interfere with the absorption, distribution, metabolism, and excretion of drugs;
- Malignancy, regardless of location;
- Autoimmune disorders such as (but not limited to) lupus erythematosus, multiple sclerosis, rheumatoid arthritis, or sarcoidosis;
- Investigational agents are prohibited one month prior to entry and for the duration of the trial;
- Currently taking medications known to be CYP2C9 inducers (e.g., carbamazepine and rifampicin;
- Currently taking cromolyn, or have taken cromolyn products, within the past 30 days;
- Non-steroidal anti-inflammatory drug (NSAID) use (products containing ibuprofen while on study);
- Allergy or hypersensitivity to cromolyn (also known as Intal®, Nasalcrom®, Opticrom®, Gastrocrom®, etc.);
- Allergy or hypersensitivity to ibuprofen (Advil®, Motrin®, Nuprin®, etc.) or aspirin, including Stevens-Johnson syndrome;
- History of hypersensitivity or allergies to any of the drug compound under investigation (cromolyn sodium, ibuprofen, lactose, or magnesium stearate);
- Current respiratory disorders and chronic respiratory disease with impaired respiratory effort or difficulty taking inhaled drugs (examples: COPD, emphysema);
- Abnormal pulmonary function test, defined for this protocol as: FEV1 < 70% of predicted value, indicating moderate or severe respiratory impairment;
- Any other disease or condition, which, in the opinion of the investigator, would make the subject unsuitable for this study;
- Female subjects of reproductive potential with a positive pregnancy test (urine or serum) or who are pregnant or lactating.
- For AD Subjects Only
- In addition to not meeting any of the above exclusion criteria for Normal Healthy Volunteers, AD subjects must also not meet any of the following criteria:
- Any significant neurological disease other than suspected incipient AD, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities;
- Major depressive episode, as described in the Diagnostic and Statistical Manual of Mental Disorders (DSM-V) within the past 6 months, which could lead to difficulty complying with the protocol;
- History of schizophrenia or bipolar disorder (DSM-V criteria);
- Currently taking medications that could lead to difficulty complying with the protocol; For All Subjects in Part A (PK)
- Aspirin, or products containing aspirin, while on PK study; For All Subjects in Part B (PD)
- Chronic daily use of aspirin exceeding standard of care guidelines for low dose aspirin therapy for prevention of stroke and/or other recommended uses, while on PD study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I/II Randomized, Open-Labeled Study to Evaluate Pharmacokinetic and Pharmacodynamic Effects and Safety of ALZT-OP1 in Subjects With Alzheimer's Disease and Normal Healthy Volunteers
This is a randomized, open-label, cross-over, pharmacokinetic and pharmacodynamic PK/PD study. (Part A)The PK portion of the study is designed to evaluate the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-administration of the two active investigational products, in healthy volunteers and Alzheimer subjects aged 55-79 and in good health. (Part B) The PD portion of the study will evaluate the pharmacodynamics of ALZT- OP1, using both plasma and CSF biomarkers, following 60 days of consecutive daily treatment, in AD subjects only.
Read the detailed description
This is a phase I/II randomized, open-label, cross-over, PK/PD study. The PK (Part A) portion of the study is designed to evaluate both single and double doses of ALZT-OP-1a (17.1mg or 34.2 mg) and ALZT-OP1b (10 mg or 20 mg) in both Alzheimer's subjects and healthy volunteers. The PD (Part B) portion of the study is designed to evaluate single doses of ALZT-OP-1a (17.1mg) and ALZT-OP1b (10 mg) in AD subjects treated for 60 days. An Alzheimer's control group will be utilized for comparison to active treatment groups but will not be administered study treatment; however, they will have biomarkers collected.
PK (Part A) n=24, both healthy volunteers and AD subjects
Part A is an open-label study, cross-over, PK study where 24 subjects will be randomly assigned to receive treatment regimen A-B or B-A for two consecutive day of dosing.
Subjects will be admitted to the Phase 1 unit the morning before dosing and will initiate dosing the following morning for 2 consecutive days of dosing (A-B, or B-A).
Day 1 (A-B) will consist of a single inhaled oral dose of ALZT-OP1a via dry powder inhaler + a single oral tablet dose of ALZT-OP1b.
Day 2 (B-A) will consist of two oral inhaled doses of ALZT-OP1a, not more than 2 mins apart, via dry powder inhaler + two oral tablets doses of ALZT-OP1b.
Day 1 (B-A) will consist of two oral inhaled doses of ALZT-OP1a, not more than 2 mins apart, via dry powder inhaler + two oral tablets doses of ALZT-OP1b.
Day 2 (A-B) regimen consists of a single inhaled oral dose of ALZT-OP1a via dry powder inhaler + a single oral tablet dose of ALZT-OP1b.
AD subjects will be given the option to roll over into the PD portion of the study.
PD (Part B) n=32, AD subjects only
Part B is an open-label, PD study where 32 AD subjects will be randomly assigned to receive either active treatment or be assigned to a non-treatment control arm.
Twenty-four (24) subjects will be randomly assigned to Treatment Group 1 to receive a single (17.1 mg) inhaled dose of ALZT-OP1a plus a single (10 mg) oral dose of ALZT-OP1b daily for 60 days.
Eight (8) subjects will be randomly assigned to Treatment Group 2 (Control Group) and will not be administered study drug.
All subjects will have plasma collected on Day 1, Day 30, and Day 60 and CSF collected on Day 1 and Day 60.
- Conditions
- Healthy Volunteers, Alzheimer Disease
- Being tested
- ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen)
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen)Drug
Also called Cromolyn, Intal, Cromolyn Sodium, Sodium cromoglycate, Ibuprofen
Drug : ALZT-OP1a
- Mast cell stabilizer
- Neuroinflammatory microglial modulator
ALZT-OP1b anti-inflammatory
Device: Dry Powder Inhaler The inhaler will be used to deliver ALZT-OP1a via oral inhalation for dosing on study.
| Study group | Role | What they receive |
|---|---|---|
| Part A | Other | 24 subjects randomized to receive treatment: (A-B) = Single 17.1 mg oral inhaled dose of ALZT-OP1a (cromolyn) via dry powder inhaler and a single oral 10 mg tablet of ALZT-OP1b (ibuprofen) on Day 1. On Day 2, subjects would receive two 17.1 mg doses of ALZT-OP1a via dry powder inhaler and two 10 mg tablets of ALZT-OP1b (ibuprofen), within two minutes of each other.
(B-A) = Two 17.1 mg doses of ALZT-OP1a (cromolyn) and two doses of 10 mg ALZT-OP1b (ibuprofen) on Day 1 and single 17.1 mg dose of ALZT-OP1a cromolyn 17.1 mg and a single 10 mg dose of ALZT-OP1b (ibuprofen) on Day 2.
All subjects will have plasma and CSF collected for PK analysis. Receives: Drug: ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen) |
| Part B | Other | PD - 32 subjects (AD only) will be enrolled in the PD portion of the study. Twenty-four (24) subjects will be assigned to Treatment Group 1 to receive a single (17.1 mg) inhaled dose of ALZT-OP1a (cromolyn) plus a single (10 mg) oral dose of ALZT-OP1b (ibuprofen) daily for 60 days.
All subjects will have plasma and CSF collected for PD biomarker analysis. Eight (8) A subjects will be assigned to Treatment Group 2 (Control Group) and will not be administered study drug. Receives: Drug: ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A Non-compartmental PK parameters will be calculated and reported for ALZT-OP1a and ALZT-OP1b
- PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF
Measured: • 2 Days
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF AUC 0-∞
Evaluation AUC 0-∞ (area under the curve from 0 to infinity)
Measured: 2 Days
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF AUC 0-t
Evaluation AUC 0-t (area under the curve from 0 to t hours where t is the last measured concentration)
Measured: 2 Days
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF AUCPLASMA/AUCCSF
Evaluation AUCPLASMA/AUCCSF (ratio at 60 min, 120 min, 240 min, 360 min and 480 min)
Measured: 2 Days
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF CL/F
Evaluation CL/F (apparent total body clearance)
Measured: 2 Days
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF Cmax
Evaluation Cmax (maximum plasma and CSF concentration observed)
Measured: 2 Days
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF t½ (half-life)
Evaluation t½ (half-life)
Measured: 2 Days
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF tmax
Evaluation tmax (sampling time at which Cmax occurred)
Measured: 2 Days
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF Vd/F
Evaluation Vd/F (apparent volume of distribution)
Measured: 2 Days
Secondary outcomes (13)
Biomarker Beta Amyloid (Αβ-42) Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation Beta Amyloid (Αβ-42)
Measured: Day 1 to Day 60
Biomarker Beta Amyloid (Αβ-40) Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation Beta Amyloid (Αβ-40)
Measured: Day 1 to Day 60
Biomarker Beta Amyloid (Αβ-38) Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation Beta Amyloid (Αβ-38)
Measured: Day 1 to Day 60
Biomarker Total Tau Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation Total Tau
Measured: Day 1 to Day 60
Biomarker Neurofilament light (Nf-L) Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation Neurofilament light (Nf-L)
Measured: Day 1 to Day 60
Biomarker Glial Fibrillary Acidic Protein (GFAP) Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation Glial Fibrillary Acidic Protein (GFAP)
Measured: Day 1 to Day 60
Biomarker P-Tau (Thr 231) Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation P-Tau (Thr 231)
Measured: Day 1 to Day 60
Biomarker Interferon-γ (IFN-γ) Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation Interferon-γ (IFN-γ)
Measured: Day 1 to Day 60
Biomarker Tumor Necrosis Factor-α (TNF-α) Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation Tumor Necrosis Factor-α (TNF-α)
Measured: Day 1 to Day 60
Biomarker Transforming Growth Factor-β1 (TGF-β1) Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation Transforming Growth Factor-β1 (TGF-β1)
Measured: Day 1 to Day 60
Biomarker CD33 Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation CD33
Measured: Day 1 to Day 60
Biomarker Triggering Receptor Expressed on Myeloid Cells-2 (TREM2) Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation Triggering Receptor Expressed on Myeloid Cells-2 (TREM2)
Measured: Day 1 to Day 60
Biomarker Neurogranin Sample Analysis plasma and CSF Day 1 to 60 Days
Evaluation Neurogranin
Measured: Day 1 to Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start28 Aug 2020
- Primary completion18 Jan 2021
- Study completion18 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Model description
- ALZT-OP1a (cromolyn) and ALZT-OP1b (Ibuprofen) are being evaluated in this study.
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- AZTherapies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- David R. Elmaleh, PhD, Study chair, AZTherapies, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04570644
- Sponsor's protocol ID
- AZT-008
- Status last verified
- Sep 2020
- First submitted
- 17 Sep 2020
- Last updated
- 3 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Randomized, Open-Labeled Study to Evaluate Pharmacokinetic and Pharmacodynamic Effects and Safety of ALZT-OP1 in Subjects With Alzheimer's Disease and Normal Healthy Volunteers
- ClinicalTrials.gov ID
- NCT04570644
- Acronym / sponsor ID
- AZT-008
- Conditions
- Healthy Volunteers, Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- AZTherapies, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Aug 2020 (actual)
- Primary completion
- 18 Jan 2021 (actual)
- Study completion
- 18 Jan 2021 (actual)
- First posted
- 30 Sep 2020 (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.
This is a randomized, open-label, cross-over, pharmacokinetic and pharmacodynamic PK/PD study. (Part A)The PK portion of the study is designed to evaluate the pharmacokinetics of ALZT-OP1 (a combination drug therapy) designated as ALZT-OP1a and ALZT-OP1b, in both plasma and CSF, following co-administration of the two active investigational products, in healthy volunteers and Alzheimer subjects aged 55-79 and in good health. (Part B) The PD portion of the study will evaluate the pharmacodynamics of ALZT- OP1, using both plasma and CSF biomarkers, following 60 days of consecutive daily treatment, in AD subjects only.
Detailed description
This is a phase I/II randomized, open-label, cross-over, PK/PD study. The PK (Part A) portion of the study is designed to evaluate both single and double doses of ALZT-OP-1a (17.1mg or 34.2 mg) and ALZT-OP1b (10 mg or 20 mg) in both Alzheimer's subjects and healthy volunteers. The PD (Part B) portion of the study is designed to evaluate single doses of ALZT-OP-1a (17.1mg) and ALZT-OP1b (10 mg) in AD subjects treated for 60 days. An Alzheimer's control group will be utilized for comparison to active treatment groups but will not be administered study treatment; however, they will have biomarkers collected.
PK (Part A) n=24, both healthy volunteers and AD subjects
Part A is an open-label study, cross-over, PK study where 24 subjects will be randomly assigned to receive treatment regimen A-B or B-A for two consecutive day of dosing.
Subjects will be admitted to the Phase 1 unit the morning before dosing and will initiate dosing the following morning for 2 consecutive days of dosing (A-B, or B-A).
Day 1 (A-B) will consist of a single inhaled oral dose of ALZT-OP1a via dry powder inhaler + a single oral tablet dose of ALZT-OP1b.
Day 2 (B-A) will consist of two oral inhaled doses of ALZT-OP1a, not more than 2 mins apart, via dry powder inhaler + two oral tablets doses of ALZT-OP1b.
Day 1 (B-A) will consist of two oral inhaled doses of ALZT-OP1a, not more than 2 mins apart, via dry powder inhaler + two oral tablets doses of ALZT-OP1b.
Day 2 (A-B) regimen consists of a single inhaled oral dose of ALZT-OP1a via dry powder inhaler + a single oral tablet dose of ALZT-OP1b.
AD subjects will be given the option to roll over into the PD portion of the study.
PD (Part B) n=32, AD subjects only
Part B is an open-label, PD study where 32 AD subjects will be randomly assigned to receive either active treatment or be assigned to a non-treatment control arm.
Twenty-four (24) subjects will be randomly assigned to Treatment Group 1 to receive a single (17.1 mg) inhaled dose of ALZT-OP1a plus a single (10 mg) oral dose of ALZT-OP1b daily for 60 days.
Eight (8) subjects will be randomly assigned to Treatment Group 2 (Control Group) and will not be administered study drug.
All subjects will have plasma collected on Day 1, Day 30, and Day 60 and CSF collected on Day 1 and Day 60.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- ALZT-OP1a (cromolyn) and ALZT-OP1b (Ibuprofen) are being evaluated in this study.
| Arm | Type | Receives |
|---|---|---|
| Part A | Other | Drug: ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen)24 subjects randomized to receive treatment: (A-B) = Single 17.1 mg oral inhaled dose of ALZT-OP1a (cromolyn) via dry powder inhaler and a single oral 10 mg tablet of ALZT-OP1b (ibuprofen) on Day 1. On Day 2, subjects would receive two 17.1 mg doses of ALZT-OP1a via dry powder inhaler and two 10 mg tablets of ALZT-OP1b (ibuprofen), within two minutes of each other. (B-A) = Two 17.1 mg doses of ALZT-OP1a (cromolyn) and two doses of 10 mg ALZT-OP1b (ibuprofen) on Day 1 and single 17.1 mg dose of ALZT-OP1a cromolyn 17.1 mg and a single 10 mg dose of ALZT-OP1b (ibuprofen) on Day 2. All subjects will have plasma and CSF collected for PK analysis. |
| Part B | Other | Drug: ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen)PD - 32 subjects (AD only) will be enrolled in the PD portion of the study. Twenty-four (24) subjects will be assigned to Treatment Group 1 to receive a single (17.1 mg) inhaled dose of ALZT-OP1a (cromolyn) plus a single (10 mg) oral dose of ALZT-OP1b (ibuprofen) daily for 60 days. All subjects will have plasma and CSF collected for PD biomarker analysis. Eight (8) A subjects will be assigned to Treatment Group 2 (Control Group) and will not be administered study drug. |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- For All Subjects
- In addition to satisfying all of the above inclusion criteria, AD subjects must also meet the following criteria:
Key exclusion criteria (28 listed)
- For All Subjects
- For AD Subjects Only
- In addition to not meeting any of the above exclusion criteria for Normal Healthy Volunteers, AD subjects must also not meet any of the following criteria:
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 |
|---|---|---|
| ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen)Also: Cromolyn, Intal, Cromolyn Sodium, Sodium cromoglycate, IbuprofenDrug : ALZT-OP1a 1. Mast cell stabilizer 2. Neuroinflammatory microglial modulator ALZT-OP1b anti-inflammatory Device: Dry Powder Inhaler The inhaler will be used to deliver ALZT-OP1a via oral inhalation for dosing on study. | Drug | Part A, Part B |
Primary outcome
Part A Non-compartmental PK parameters will be calculated and reported for ALZT-OP1a and ALZT-OP1b
Time frame: • 2 Days
• PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF AUC 0-∞
Time frame: 2 Days
Evaluation AUC 0-∞ (area under the curve from 0 to infinity)
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF AUC 0-t
Time frame: 2 Days
Evaluation AUC 0-t (area under the curve from 0 to t hours where t is the last measured concentration)
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF AUCPLASMA/AUCCSF
Time frame: 2 Days
Evaluation AUCPLASMA/AUCCSF (ratio at 60 min, 120 min, 240 min, 360 min and 480 min)
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF CL/F
Time frame: 2 Days
Evaluation CL/F (apparent total body clearance)
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF Cmax
Time frame: 2 Days
Evaluation Cmax (maximum plasma and CSF concentration observed)
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF t½ (half-life)
Time frame: 2 Days
Evaluation t½ (half-life)
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF tmax
Time frame: 2 Days
Evaluation tmax (sampling time at which Cmax occurred)
PK profile for ALZT-OP1a and ALZT-OP1b in plasma and CSF Vd/F
Time frame: 2 Days
Evaluation Vd/F (apparent volume of distribution)
13 secondary outcomes
Biomarker Beta Amyloid (Αβ-42) Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
Biomarker Beta Amyloid (Αβ-40) Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
Biomarker Beta Amyloid (Αβ-38) Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
Biomarker Total Tau Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
Biomarker Neurofilament light (Nf-L) Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
Biomarker Glial Fibrillary Acidic Protein (GFAP) Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
Biomarker P-Tau (Thr 231) Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
Biomarker Interferon-γ (IFN-γ) Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
Biomarker Tumor Necrosis Factor-α (TNF-α) Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
Biomarker Transforming Growth Factor-β1 (TGF-β1) Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
Biomarker CD33 Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
Biomarker Triggering Receptor Expressed on Myeloid Cells-2 (TREM2) Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
Biomarker Neurogranin Sample Analysis plasma and CSF Day 1 to 60 Days
Time frame: Day 1 to Day 60
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 3 Mar 2022.
- Pharmacokinetics of Cromolyn and Ibuprofen in Healthy Elderly VolunteersLink provided by the sponsor.
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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.
David R. Elmaleh, PhD study chair
AZTherapies, Inc.
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 ALZT-OP1 (cromolyn and ibuprofen) ALZT-OP1a (cromolyn) and ALZT-OP1b (ibuprofen) in people with Healthy Volunteers and Alzheimer Disease, run by AZTherapies, 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 19 inclusion and 28 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 3 Mar 2022. 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?
Part A Non-compartmental PK parameters will be calculated and reported for ALZT-OP1a and ALZT-OP1b (time frame: • 2 Days). The study lists 9 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 3 Mar 2022.