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)

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 60
Healthy Volunteers: t
View:

• Be over 60 years old;

• Have been diagnosed with AD at least 1 year ago;

• Present mild to moderate symptoms of AD.

Locations
Other Locations
Brazil
Federal University of Latin American Integration
Foz Do Iguaçu
Time Frame
Start Date: 2024-08-13
Completion Date: 2025-03-27
Participants
Target number of participants: 72
Treatments
Placebo_comparator: Placebo arm
Patients will receive a liquid solution only with vehicle and no cannabinoid.
Experimental: Experimental arm
Patients will receive the dose of 0,2 ml of a compound contain CBD:THC (50 mg:5 mg).
Related Therapeutic Areas
Sponsors
Leads: Federal University of Latin American Integration

This content was sourced from clinicaltrials.gov