Alzheimer Disease study: CBD
Official title Cannabidiol Medication Intervention Trial
ClinicalTrials.gov ID: NCT06014424
What this study is testing
What is CBD?
This is an investigational capsule being studied to see if it helps manage agitation in people with Alzheimer's disease.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to see if CBD capsules are safe and effective for managing agitation. It also looks for new ways to measure how severe agitation is and how well it responds to treatment.
- Who it's for
- The study is looking for people with Alzheimer's disease who experience agitation.
- What's involved
- Participants will take CBD capsules or a placebo (a pill with no active ingredient) in a random order. They will undergo tests to check for safety and measure agitation levels.
- Time commitment
- The source text does not specify the total duration or the number of visits required.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 and older
You may be able to join if
- Males or females ≥55 years of age; female must be post-menopausal or must agree to comply with contraception requirements.
- Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria for Major Neurocognitive Disorder due to possible AD.
- sMMSE ≤24
- Presence of clinically significant agitation based on the IPA definition at both screening and baseline
- If treated with cognitive-enhancing medications (cholinesterase inhibitors and/or memantine), dosage must be stable for at least 3 months prior to...
You likely can't join if
- Change in psychotropic medications less than the duration of 5 half-lives of the medication in question prior to screening (e.g., concomitant...
- Contraindications to CBs, e.g. allergies to cannabis and cannabis products, potential clinically important drug-drug interactions (e.g.
- Vascular disease, clinically important cerebrovascular disease or current uncontrolled cardiovascular disease (e.g.
- Clinically significant liver disease, as reflected by serum alanine aminotransferase or aspartate aminotransferase \> 2 x upper limit of normal...
- Clinically significant impaired renal function at screening, as per investigator assessment
- Currently meeting DSM 5 criteria for Major Depressive Episode Presence, or current substance dependence (excluding caffeine and nicotine) or history...
See the full eligibility criteria
- Males or females ≥55 years of age; female must be post-menopausal or must agree to comply with contraception requirements.
- Diagnostic and Statistical Manual of Mental Disorders-5 (DSM 5) criteria for Major Neurocognitive Disorder due to possible AD.
- sMMSE ≤24
- Presence of clinically significant agitation based on the IPA definition at both screening and baseline
- If treated with cognitive-enhancing medications (cholinesterase inhibitors and/or memantine), dosage must be stable for at least 3 months prior to study randomization
- Availability of a primary caregiver to accompany the participant to study visits and to participate in the study.
- Willing and able to provide informed consent and/or have a Substitute Decision Maker (SDM) provide informed consent on behalf of the participant
- Change in psychotropic medications less than the duration of 5 half-lives of the medication in question prior to screening (e.g., concomitant antidepressants or atypical antipsychotics) and any changes during study...
- Contraindications to CBs, e.g. allergies to cannabis and cannabis products, potential clinically important drug-drug interactions (e.g. strong CYP3A4 inducers/inhibitors, anticonvulsants)
- Vascular disease, clinically important cerebrovascular disease or current uncontrolled cardiovascular disease (e.g.
- Clinically significant liver disease, as reflected by serum alanine aminotransferase or aspartate aminotransferase \> 2 x upper limit of normal (ULN), or total bilirubin \> 1.5 x ULN
- Clinically significant impaired renal function at screening, as per investigator assessment
- Currently meeting DSM 5 criteria for Major Depressive Episode Presence, or current substance dependence (excluding caffeine and nicotine) or history of other major psychiatric disorders or neurological conditions (e.g.
- Substance-Related Disorders (excluding caffeine and nicotine)
- Clinically significant delusions and/or hallucinations (e.g. NPI-NH delusion/hallucinations subscore ≥4 or judgement of QI)
- Reported use of marijuana or cannabinoid-based medications, products or supplements (botanical or synthetic) within 1 week prior to randomization
- Systolic blood pressure (SBP) \ 150 mmHg or diastolic blood pressure (DBP) \ 105 mmHg at screening or baseline (prior to randomization) or a postural drop in SBP ≥ 20 mmHg or DBP ≥ 10 mmHg at screening
The study team makes the final eligibility decision.
Where it is enrolling
- Calgary, Alberta, Canada
- London, Ontario, Canada
- Toronto, Ontario, Canada
- Whitby, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Calgary, Alberta, Canada; London, Ontario, Canada; Toronto, Ontario, Canada; Whitby, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.