Use of a Product Containing the Cannabinoids CBD and THC as a Treatment Strategy for Alzheimer's Disease - Alzheimer's Disease and Cannabis Clinical Trial (DAZACANN) Open-Label Phase

NCT07091747 | Active Not Recruiting Phase 1 DMC

• 2 other identifiers: DAZACANN Open-Label PhaseCAAE: 86640925.4.0000.8527
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Alzheimer's Disease (AD) has become a significant public health issue due to the increase in its incidence from 2.0 to 16.8 cases per thousand people in a year, based on 2022 data. As many countries experience population aging, there is an increase in the prevalence of AD cases, which is the main form of dementia in the elderly. It commonly begins around the age of 60, with aging being the primary risk factor. AD is a neurodegenerative disorder characterized by the presence of extracellular beta-amyloid plaques and intracellular neurofibrillary tangles of Tau protein. Among the main symptoms of AD is progressive memory loss, with varying degrees of cognitive impairment. These symptoms share common clinical features such as a progressive decline in cognitive functions, including abstract thinking, judgment, language, personality changes, and behavioral symptoms, as well as the emergence of certain comorbidities. As there are currently no curative treatments for this disease, pharmacotherapy aims to control the progressive symptoms, improving cognitive and functional aspects in patients, and consequently their quality of life. In this context, there is a need for further research to identify effective drugs that can delay or alleviate symptoms. This study is part of the second phase of the project entitled: Use of a Product Containing the Cannabinoids CBD and THC as a Treatment Strategy for Alzheimer's Disease - Alzheimer's Disease and Cannabis Clinical Trial (DAZACANN): A randomized, double-blind, placebo-controlled clinical trial previously approved by the Human Ethics Committee - CEP (CAAE 60167722.6.0000.0107). The trial is being finalized at the Laboratory of Medicinal Cannabis and Psychedelic Science, located in the city of Foz do Iguaçu, Paraná, and will continue with a new experimental design, now as an open-label trial (all participants will receive the extract and will be informed about the formulation they are receiving). The objective of this study remains to evaluate the clinical and biochemical effects of using cannabinoid-based products with low doses of purified CBD and THC, both individually and in combination, in patients with AD.

Conditions

Alzheimer Disease (AD)

Keywords

Alzheimer's Disease; Cannabidiol (CBD); Tetrahydrocannabinol (THC); Open Label

Outcome Measures

Primary Outcomes (1)

• Mini Mental State Examination

  Assess cognitive function and disease progression. Cognitive function preserved (27 to 30 points), Mild cognitive impairment (21 to 26 points), Moderate cognitive impairment (10 to 20 points), Severe cognitive impairment (0 to 9 points).

  24 months

Secondary Outcomes (7)

• Neuropsychiatric Inventory

  24 months

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

  24 month

• Epworth Sleepiness Scale (ESS )

  24 month

• Specific markers of Alzheimer's disease

  24 month

• Brain Derived Neurotrophic Factor

  24 month

Study Arms (1)

Open label group

EXPERIMENTAL

They will use the extract at a daily dose of 50 mg of CBD and 5 mg of THC from a product with a CBD:THC concentration of 50 mg/ml:5 mg/ml for a period of 24 months.

Other: Cannabis 50 mg of CBD and 5 mg of THC

Interventions

Cannabis 50 mg of CBD and 5 mg of THC OTHER

Cannabis 50 mg of CBD and 5 mg of THC

Open label group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Have participated in and completed all assessments conducted in the first phase of the project.
• Agree to and sign a new informed consent form.

You may not qualify if:

• Patients who did not participate in the first stage.
• Patients who began participating in the first stage but withdrew at any time.
• Patients who do not agree and/or fail to sign the new informed consent form

Sponsors & Collaborators

• Federal University of Latin American Integration: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator

Study Sites (1)

Universidade Federal da Integração Latino-Americana

Foz do Iguaçu, Paraná, 85870-650, Brazil

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

nabiximols; Dronabinol

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: July 29, 2025
• Study Start: April 7, 2025
• Primary Completion: December 12, 2025
• Study Completion: December 12, 2025
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)