Phase 2 Alzheimer's Disease Trial, Recruiting NCT05543681 Sponsor: IGC Pharma, LLC Condition: Alzheimer's Disease
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Phase 2 Alzheimer's Disease Trial, Recruiting

NCT05543681
Recruiting Phase 2

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You (or your caregiver) must be willing and able to sign and date a consent form before any study activities begin.
  • You must have a caregiver who is willing and able to take part in all required study activities.
  • Your caregiver must know you personally and be comfortable using everyday technology like a cell phone, video calls, a weighing scale, and be willing to learn how to take blood pressure readings.
  • If you are unable to give consent yourself, a caregiver may be able to consent on your behalf, provided they have legal authority (such as Power of Attorney) or are a spouse, sibling, child, or close relation (confirm with trial site).
  • You must agree to provide a DNA sample to test for certain genes (CYP450 and ApoE) and to have your body's processing of the study drug monitored.
  • You must have been diagnosed with Alzheimer's disease using standard medical guidelines.
  • You must have significant, ongoing agitation related to your Alzheimer's, as measured by specific assessment tools, that is not caused by another mental health condition, poor care, another medical issue, or a substance.
  • You must test negative on a drug screen, unless you have been taking benzodiazepines (a type of calming medication) at a stable dose for at least 3 months before the screening.
  • Any medications you take for behavioural symptoms must have been at a consistent dose for at least 6 weeks before screening (small dose adjustments of up to 25% are allowed).
  • Women must either be past menopause (no periods for at least 12 months) or have had a surgical procedure that means they cannot become pregnant.

Who may not be able to join:

  • You have previously had a bad reaction to cannabis-based products or to any ingredient in the study drug.
  • You have a serious or unstable medical condition affecting the heart, liver, kidneys, lungs, hormones, nervous system, or blood, which could affect the safety results of the study.
  • You have a history of seizures, schizophrenia, or bipolar disorder.
  • You have taken part in another clinical trial involving an experimental drug or device within the past 30 days.
  • Your drug screen comes back positive, unless you have been taking benzodiazepines at a stable dose for at least 6 weeks before screening.
  • You have had a problem with alcohol or drug misuse within the past year.
  • You have a history of uncontrolled high blood pressure, or you have had a severe high blood pressure episode in the 6 months before joining the trial.
  • You have had more than two falls in the 6 months before joining, or any fall that led to injury, loss of consciousness, fever, illness, or abnormal blood pressure.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 2 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 2
Sponsor
IGC Pharma, LLC
Registry
ClinicalTrials.gov
Start date
11 October 2022
Est. completion
1 August 2026

Where this trial is recruiting

🇨🇦 Canada 🇨🇴 Colombia Puerto Rico 🇺🇸 United States

Primary endpoints

Agitation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 2 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov