Phase 2 Alzheimer's Disease Trial, Recruiting NCT06014424 Sponsor: Sunnybrook Health Sciences Centre Condition: Alzheimer's Disease
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Phase 2 Alzheimer's Disease Trial, Recruiting

NCT06014424
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 are 55 years of age or older; women must be post-menopausal or agree to use an approved form of birth control, and men must also use contraception if their partner could become pregnant
  • You have been diagnosed with major memory loss or dementia thought to be caused by Alzheimer's disease (including cases where both Alzheimer's and vascular causes are involved)
  • You have scored 24 or below on a standard memory and thinking test called the sMMSE
  • You are showing noticeable agitation (restlessness or distress) that was confirmed at both your screening and baseline appointments
  • If you are already taking memory-related medications (such as cholinesterase inhibitors or memantine), your dose has been stable for at least 3 months before joining the study
  • You have a primary caregiver who can attend study visits with you, spends at least 10 hours a week with you, and is sufficiently able to communicate in English
  • You are able to give your own consent to participate, or someone legally authorised to make decisions on your behalf can do so

Who may not be able to join:

  • Your mental health medications (such as antidepressants or antipsychotics) have been changed too recently before screening, or you plan to change them during the study
  • You have a known allergy to cannabis or cannabis products, or take medications that could interact badly with cannabinoids (confirm with trial site)
  • You have significant blood vessel disease, serious cerebrovascular disease, or uncontrolled heart conditions — including uncontrolled high blood pressure, heart disease, irregular heartbeat, severe heart failure, or a stroke in the 3 months before screening
  • Your liver function blood tests show results significantly above the normal range
  • You have significantly reduced kidney function, as judged by the study doctor
  • You are currently experiencing a major depressive episode, have a history of serious psychiatric conditions (such as schizophrenia or psychosis), or neurological conditions such as epilepsy or stroke
  • You currently have a substance use disorder (not including caffeine or nicotine)
  • You are experiencing significant delusions or hallucinations
  • You have used marijuana or any cannabis-based products within 1 week before joining the study
  • Your blood pressure readings at screening or baseline are outside the acceptable range, or you experience a significant drop in blood pressure when standing up

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 22 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.

Contact this trial

Principal Investigator: Krista L. Lanctot, PhD, Sunnybrook Research Institute

Phone: 416-480-6100

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Phase 2
Registry
ClinicalTrials.gov
Start date
27 September 2023
Est. completion
29 December 2026

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Agitation - Cohen-Mansfield Agitation Inventory (CMAI)

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: 22 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