Dementia of Alzheimer TypePhase 1NCT04749563
Study of IGC-AD1 in Subjects With Dementia Due to Alzheimer's Disease
A Phase 1 study testing IGC AD1 in people with Dementia of Alzheimer Type, run by IGC Pharma, LLC at 1 site in Puerto Rico.
Trial summary
A single center, randomized, placebo controlled multiple ascending dose study of IGC AD1 to evaluate safety and tolerability in subjects with dementia due to Alzheimer's Disease (AD). Read more about this study
- Who is it for?
- Ages 60 to 99 years
- Conditions the study is for
- Dementia of Alzheimer Type
- What is being tested?
- IGC AD1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 sitePuerto Rico
- Study dates
- 11 Jan 2021to 20 Jun 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 60 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient and/or study partner (relative) must provide a signed and dated Informed Consent form prior to any study procedures which will be discussed with the Study Coordinator.
- Provision of a letter from the Neurologist/Psychiatrist/Internal Medicine Physician certifying the diagnosis of Alzheimer's Dementia and patient's ability to consent. If patient is unable to consent, only the legal guardian/tutor of the patient could consent in his/her behalf. The guardian/tutor will be required to present the pertinent legal documentation.
- Must have a study partner who is able and willing to comply with all required study procedures.
- Patient should meet NIA-AA criteria for Alzheimer's disease, any stage.
- At least 3 months evolution of behavioral symptoms at screening visit.
- Negative drug screen, except for benzodiazepines if patient has been using them in stable doses for at least 3 months before screening.
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- All medications used for behavioral symptoms should be in stable doses for at least 3 months before screening.
- All medications used for other conditions besides behavioral symptoms should be at stable doses for at least 30 days before screening.
- Women must be postmenopausal (defined as cessation of menses for at least 1 year) or surgically sterile (hysterectomy, oophorectomy or bilateral tubal ligation) at the time of screening.
Who cannot join
- Prior adverse reaction to cannabinoids.
- Prior contraindication or allergy to any component of study product (IGC-AD1): melatonin, honey, curcumin, ethyl alcohol, vitamin-E TPGS, ascorbic acid, water, tween-80, and rutin.
- History of stroke, multiple sclerosis (MS), or epilepsy. History of gastrointestinal dysfunction not related to Alzheimer's disease (e.g., inflammatory bowel disease or gastrointestinal cancer)
- Any clinically relevant neurological disorder capable of producing a dementia syndrome including Parkinson's disease, stroke, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, and others.
- Other possible causes of dementia as: infections of the CNS (e.g. HIV, syphilis) or Creutzfeldt Jakob disease, subdural hematoma, communicating hydrocephalus, brain tumors, drug intoxication, alcohol intoxication, thyroid disease, parathyroid disease, and vitamin B12 or other deficiencies
- Use of contraindicated medication (see section 6).
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- History of myocardial infarction, severe congestive heart failure, unstable angina, significant valvular disease, or cardiomyopathy within 1 year of screening.
- History of cardiac arrhythmias, second or third-degree AV block.
- History of seizures, schizophrenia, or bipolar disorder.
- Other condition or clinically important abnormality on vital signs, physical examination, neurologic examination, laboratory results or electrocardiogram (ECG) examination that could compromise the study efficacy interpretation or safety of the subject.
- Have participated in an investigational drug or device study within 30 days prior to study start.
- TCA or opioid use within 30 days before the enrollment.
- History of alcohol and drug abuse within 2 years of screening.
- Elevated liver enzymes (AST or ALT ≥3 times upper limit of normal, Total bilirubin≥1.5 times ULN or ALP≥1.5 times ULN).
- Urine drug screen positive for drug use, except for benzodiazepines if patient was using them previously and their dose had remained stable for at least 3 months before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Randomized Placebo Controlled MAD Study to Evaluate Safety and Tolerability of IGC-AD1 in Subjects With Dementia Due to Alzheimer's Disease
A single center, randomized, placebo controlled multiple ascending dose study of IGC AD1 to evaluate safety and tolerability in subjects with dementia due to Alzheimer's Disease (AD).
Read the detailed description
This is a phase I Multiple Ascending Dose (MAD) study to evaluate safety and tolerability of IGC-AD1 in subjects with AD. Twelve subjects will be enrolled. Three different ascending doses of the study product will be given: low, medium and high doses. Each dose will be given for 2 weeks, followed by a washout period of 4 days. Given the vulnerability of the population, a safety cohort of 3 patients (2 active, 1 placebo) will start every dose one day ahead of the rest of the patients and will be followed for 24 hours for the development of Adverse Events (AEs). Objective criteria will be set after the safety cohort is evaluated.
- Conditions
- Dementia of Alzheimer Type
- Being tested
- IGC AD1, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IGC AD1Drug
IGC AD1 oral Solution
PlaceboDrug
Placebo of IGC AD1 oral Solution
| Study group | Role | What they receive |
|---|---|---|
| Active | Active comparator | IGC AD1 Receives: Drug: IGC AD1 |
| Placebo | Placebo comparator | IGC AD1 Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-emergent adverse events in IGC-AD1 as compared to placebo [Safety and Tolerability]
Evaluate safety and tolerability of IGC AD1 10 participants will be administered the investigational drug and two will be administered placebo. Incidence of treatment emergent adverse events will be assessed to determine safety and tolerability of IGC-AD1.
Measured: 3 weeks
Secondary outcomes (1)
Measurement of efficacy using Neuropsychiatric Inventory (NPI) scale
Secondary Outcome: Comparison of the measurement of Neuropsychiatric Inventory (NPI) scale changes from baseline using the Suicide Severity Rating Scale (C-SSRS)
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start11 Jan 2021
- Primary completion20 Jun 2021
- Study completion20 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia of Alzheimer TypeStudies 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
- Sequential
- Model description
- 3 dose escalation cohorts in same 12 subjects (5:1 randomization (active:placebo)
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- IGC Pharma, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- IGC Pharma INC, Study director, IGC Pharma INC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749563
- Sponsor's protocol ID
- P1 IGC-AD1 BPSD
- Status last verified
- Sep 2022
- First submitted
- 29 Dec 2020
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Randomized Placebo Controlled MAD Study to Evaluate Safety and Tolerability of IGC-AD1 in Subjects With Dementia Due to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT04749563
- Acronym / sponsor ID
- P1 IGC-AD1 BPSD
- Conditions
- Dementia of Alzheimer Type
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- IGC Pharma, LLCIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 20 Jun 2021 (actual)
- Study completion
- 20 Jun 2021 (actual)
- First posted
- 11 Feb 2021 (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.
A single center, randomized, placebo controlled multiple ascending dose study of IGC AD1 to evaluate safety and tolerability in subjects with dementia due to Alzheimer's Disease (AD).
Detailed description
This is a phase I Multiple Ascending Dose (MAD) study to evaluate safety and tolerability of IGC-AD1 in subjects with AD. Twelve subjects will be enrolled. Three different ascending doses of the study product will be given: low, medium and high doses. Each dose will be given for 2 weeks, followed by a washout period of 4 days. Given the vulnerability of the population, a safety cohort of 3 patients (2 active, 1 placebo) will start every dose one day ahead of the rest of the patients and will be followed for 24 hours for the development of Adverse Events (AEs). Objective criteria will be set after the safety cohort is evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 3 dose escalation cohorts in same 12 subjects (5:1 randomization (active:placebo)
| Arm | Type | Receives |
|---|---|---|
| Active | Active comparator | Drug: IGC AD1IGC AD1 |
| Placebo | Placebo comparator | Drug: PlaceboIGC AD1 Placebo |
Who may qualify
- Ages
- 60 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patient and/or study partner (relative) must provide a signed and dated Informed Consent form prior to any study procedures which will be discussed with the Study Coordinator.
- Provision of a letter from the Neurologist/Psychiatrist/Internal Medicine Physician certifying the diagnosis of Alzheimer's Dementia and patient's ability to consent. If patient is unable to consent, only the legal guardian/tutor of the patient could consent in his/her behalf. The guardian/tutor will be required to present the pertinent legal documentation.
- Must have a study partner who is able and willing to comply with all required study procedures.
- Patient should meet NIA-AA criteria for Alzheimer's disease, any stage.
- At least 3 months evolution of behavioral symptoms at screening visit.
Key exclusion criteria (15 listed)
- Prior adverse reaction to cannabinoids.
- Prior contraindication or allergy to any component of study product (IGC-AD1): melatonin, honey, curcumin, ethyl alcohol, vitamin-E TPGS, ascorbic acid, water, tween-80, and rutin.
- History of stroke, multiple sclerosis (MS), or epilepsy. History of gastrointestinal dysfunction not related to Alzheimer's disease (e.g., inflammatory bowel disease or gastrointestinal cancer)
- Any clinically relevant neurological disorder capable of producing a dementia syndrome including Parkinson's disease, stroke, vascular dementia, dementia with Lewy bodies, frontotemporal dementia, and others.
- Other possible causes of dementia as: infections of the CNS (e.g. HIV, syphilis) or Creutzfeldt Jakob disease, subdural hematoma, communicating hydrocephalus, brain tumors, drug intoxication, alcohol intoxication, thyroid disease, parathyroid disease, and vitamin B12 or other deficiencies
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 |
|---|---|---|
| IGC AD1IGC AD1 oral Solution | Drug | Active |
| PlaceboPlacebo of IGC AD1 oral Solution | Drug | Placebo |
Primary outcome
Incidence of treatment-emergent adverse events in IGC-AD1 as compared to placebo [Safety and Tolerability]
Time frame: 3 weeks
Evaluate safety and tolerability of IGC AD1 10 participants will be administered the investigational drug and two will be administered placebo. Incidence of treatment emergent adverse events will be assessed to determine safety and tolerability of IGC-AD1.
1 secondary outcome
Measurement of efficacy using Neuropsychiatric Inventory (NPI) scale
Time frame: 3 weeks
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 16 Sep 2022.
- Individual participant dataSharing planned: No
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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.
IGC Pharma INC study director
IGC Pharma 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 IGC AD1 in people with Dementia of Alzheimer Type, run by IGC Pharma, LLC at 1 site in Puerto Rico.
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 9 inclusion and 15 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 16 Sep 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 Puerto Rico. 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. Some participants in this study may receive a placebo. 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?
Incidence of treatment-emergent adverse events in IGC-AD1 as compared to placebo [Safety and Tolerability] (time frame: 3 weeks). 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 16 Sep 2022.