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Use of a Cannabinoids as a Treatment Strategy for Alzheimer's Disease

NCT06570928 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-05-25

No results posted yet for this study

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.

Conditions

  • Alzheimer Disease

Interventions

OTHER

Cannabis

0,2 ml of CBD:THC (50 mg:5 mg)

OTHER

Placebo

Product vehicle, medium chain triglycerides (MCT)

Sponsors & Collaborators

  • Federal University of Latin American Integration

    lead OTHER

Principal Investigators

  • Taynara Silva, 1 · Universidade Federal de Santa Catarina

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-08-13
Primary Completion
2024-08-27
Completion
2025-03-27

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06570928 on ClinicalTrials.gov