Phase 3 Alzheimer's Disease Trial, Recruiting NCT04516057 Sponsor: Sunnybrook Health Sciences Centre Condition: Alzheimer's Disease
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Phase 3 Alzheimer's Disease Trial, Recruiting

NCT04516057
Recruiting Phase 3

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People aged 55 or older (both men and women are eligible, but women must be post-menopausal)
  • People who have been diagnosed with major dementia caused by Alzheimer's disease, including those whose dementia is thought to be caused by both Alzheimer's disease and problems with blood flow to the brain
  • People who score 24 or below on a standard memory and thinking test called the sMMSE
  • People who are experiencing significant agitation (restlessness or distressed behaviour) as defined by a specific clinical standard called the IPA definition
  • People taking memory medications (such as cholinesterase inhibitors and/or memantine) whose dose has been stable for at least 3 months before joining the study
  • People who have a primary carer available to attend study visits with them and take part in the study, where that carer has a sufficient level of English to complete the required study assessments, as determined by the study investigator

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People whose medications for mood or mental health were changed less than one week before joining the study (for example, antidepressants)
  • People who have known reasons they should not take cannabinoids, such as an allergy to cannabis or cannabis products, or who are taking other medications that may interact dangerously with cannabinoids
  • People who currently have uncontrolled heart or circulation problems (such as uncontrolled high blood pressure, heart disease, irregular heartbeat, or serious heart failure), as assessed by the study doctor
  • People who currently have significant liver disease, as assessed by the study doctor
  • People who have, or have had, other mental health or neurological conditions such as psychotic disorders, schizophrenia, stroke, or epilepsy
  • People who currently meet the clinical criteria for a Major Depressive Episode (a serious form of depression), as defined by DSM-5
  • People who have previously or currently misused or been dependent on marijuana
  • People who are experiencing significant delusions (strong false beliefs) and/or hallucinations (seeing or hearing things that are not there), based on a specific clinical scoring threshold
  • People who have used marijuana or other cannabis products for recreational purposes within the 3 months before joining the study

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 18 August 2026

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 3
Registry
ClinicalTrials.gov
Start date
1 February 2021
Est. completion
1 April 2027

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: 18 August 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