NCT06570928CompletedPhase 2
Use of a Cannabinoids as a Treatment Strategy for Alzheimer's Disease
Use of a Product Containing the Cannabinoids CBD and THC as a Treatment Strategy for Alzheimer's Disease - Clinical Trial Alzheimer's Disease and Cannabis (DAZACANN)
Source: ClinicalTrials.gov · Last updated 25 May 2025
Brief summary (registry, in English)
Brief Summary: The objective of the study is to evaluate the effect of cannabinoids on Alzheimer's Disease. This is a double-blind, randomized, placebo-controlled clinical trial. The study aims to recruit patients of both sexes diagnosed with Alzheimer's Disease who are in the mild and moderate stages for treatment with cannabinoids. The specific objectives of the study are: Primary Outcome * To evaluate the effect of Cannabis sativa at low doses according to the Mini-Mental State Examination (MMSE) scale - Memory and Cognition test - in patients with Alzheimer's Disease. Secondary Outcomes * To evaluate the effect of Cannabis sativa at low doses according to the Cornell scale - Depression in dementia test. * To evaluate the effect of Cannabis sativa at low doses according to the GDS scale - Depression in elderly people test. * To evaluate the effect of Cannabis sativa at low doses according to the QoL scale - Quality of Life test. * To evaluate the effect of Cannabis sativa at low doses according to the Epworth scale - Drowsiness test. * To evaluate the adverse effects of Cannabis sativa at low doses given daily for 26 weeks in patients with Alzheimer's Disease. Participants will use a compound containing CBD/THC 50/5 mg/mL, administered as 0.2 mL once a day. The placebo group will use a compound identical to the treatment but containing only vehicle. To address the questions above, the treated group will be compared with the placebo group over a period of 6 months. Participants will be assessed every 2 months. Additionally, blood and cerebrospinal fluid tests will be conducted to measure specific proteins related to Alzheimer's Disease and inflammatory markers.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 72 (actual)
- First submitted
- 19 Aug 2024
- Start date
- 13 Aug 2024
- Primary completion date
- 27 Aug 2024
- Lead sponsor
- Federal University of Latin American Integration
- Diseases
- Alzheimer disease
- NCT number
- NCT06570928
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 72
- From 13 Aug 2024 to the primary completion date, 27 Aug 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Present psychosis or first-degree relatives with a history from psychosis, schizophrenia, epilepsy;
- Individuals with a history of psychoactive substance abuse will be included in the study;
Other
- Have a diagnosis of other dementias or factors correlated;
- Present severe symptoms of AD.
Who the study is looking for
- Be over 60 years old;
- Have been diagnosed with AD at least 1 year ago;
- Present mild to moderate symptoms of AD.
Age in the registry: 60 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Federal University of Latin American Integration Coordinator of this site? Confirm its status | Foz do Iguaçu | Brazil | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.