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

NCT06570928 | Completed Phase 2 DMC

• 1 other identifier: DAZACANN
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Alzheimer Disease; Cannabinoids; Cannabidiol; Tetrahydrocannabinol (THC); Nervous System Diseases

Outcome Measures

Primary Outcomes (1)

• Mini Mental State Exam (MMSE)

  scores range from 0 to 30, with higher scores indicating cognitive improvement.

  The participants will be evaluated before starting treatment, and then every 60 days until 180 days are complete, resulting in 4 evaluations.

Secondary Outcomes (8)

• Neuropsychiatric Inventory-Questionnaire (NPI-Q)

  The participants will be evaluated before starting treatment, and then every 60 days until 180 days are complete, resulting in 4 evaluations.

• Geriatric Depression Scale (GDS)

  The participants will be evaluated before starting treatment, and then every 60 days until 180 days are complete, resulting in 4 evaluations.

• Quality of Life in Alzheimer's Disease scale (QoL-AD)

  The participants will be evaluated before starting treatment, and then every 60 days until 180 days are complete, resulting in 4 evaluations.

• Cornell Scale for Depression in Dementia (CSDD)

  The participants will be evaluated before starting treatment, and then every 60 days until 180 days are complete, resulting in 4 evaluations.

• Epworth Sleepiness Scale (ESS )

  The participants will be evaluated before starting treatment, and then every 60 days until 180 days are complete, resulting in 4 evaluations.

Other Outcomes (1)

• Safety Endpoints - UKU Side Effect Rating Scale

  The participants will be evaluated before starting treatment, and then every 60 days until 180 days are complete, resulting in 4 evaluations.

Study Arms (2)

Placebo arm

PLACEBO COMPARATOR

Patients will receive a liquid solution only with vehicle and no cannabinoid.

Other: Placebo

Experimental arm

EXPERIMENTAL

Patients will receive the dose of 0,2 ml of a compound contain CBD:THC (50 mg:5 mg).

Other: Cannabis

Interventions

Cannabis OTHER

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

Also known as: CBD:THC (50 mg:5 mg)

Experimental arm

Placebo OTHER

Product vehicle, medium chain triglycerides (MCT)

Placebo arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be over 60 years old;
• Have been diagnosed with AD at least 1 year ago;
• Present mild to moderate symptoms of AD.

You may not qualify if:

• Have a diagnosis of other dementias or factors correlated;
• 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;
• Present severe symptoms of AD.

Sponsors & Collaborators

• Federal University of Latin American Integration: lead

Study Sites (1)

Federal University of Latin American Integration

Foz do Iguaçu, Paraná, 85870-650, Brazil

Location

MeSH Terms

Conditions

Alzheimer Disease; Nervous System Diseases

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Taynara Silva, 1

  Universidade Federal de Santa Catarina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants and caregivers will not know what they are using. The investigators evaluating it won't know either. Only a team member who is not part of the investigative team will know.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Coordinator of the Laboratory of Medicinal Cannabis and Psychedelic Science

Model Details: 72 patients will be randomized into 2 groups. One group will receive a product containing CBD/THC and the other group will receive a placebo, a compound with the same characteristics, without an active ingredient.

Study Record Dates

• First Submitted: August 19, 2024
• First Posted: August 26, 2024
• Study Start: August 13, 2024
• Primary Completion: August 27, 2024
• Study Completion: March 27, 2025
• Last Updated: May 25, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)