A Phase 1/2 interventional study of Cannabis 50 mg of CBD and 5 mg of THC in Alzheimer Disease (AD), sponsored by Federal University of Latin American Integration. Active, not recruiting at 1 site in Brazil. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2025-08-12.
Sponsored by Federal University of Latin American Integration · Phase 1/2, Interventional, and Treatment
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.
3,681 studies on the registry are indexed under Alzheimer Disease; 875 are open to participants now.
This study's enrollment of 61 is below the median of 70 across 2,809 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Federal University of Latin American Integration is the lead sponsor of 6 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
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
Cannabis 50 mg of CBD and 5 mg of THC
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).
Time frame: 24 months
Neuropsychiatric Inventory
Identify neuropsychiatric symptoms across different domains using the Neuropsychiatric Inventory. Score Range: 0-20 Mild symptoms or no significant impairment, 21-50 Moderate symptoms, 51-120 Severe symptoms with major impact
Time frame: 24 months
Quality of Life in Alzheimer's Disease scale (QoL-AD)
The scale has 3 versions, one of which is applied to the patient, another to the caregiver to answer about the patient's life, and one for the caregiver to answer about their own life. The score may vary, the one the investigators will use is the sum of the questionnaires about the patient, caregiver version and patient version, with the patient version having a weight of 2. Its score varies from 13, indicating the worst possible quality of life, up to 52, and the higher the score, the higher the quality of life.
Time frame: 24 month
Epworth Sleepiness Scale (ESS )
Evaluates 8 items with scores ranging from 0 to 24, in which scores higher than 10 indicate sleep disturbances.
Time frame: 24 month
Specific markers of Alzheimer's disease
The following proteins will be quantified in the cerebrospinal fluid: beta-amyloid 40, beta-amyloid 42, tau protein (fraction 181), and phosphorylated tau protein.
Time frame: 24 month
Brain Derived Neurotrophic Factor
It will be measured in serum or plasma
Time frame: 24 month
Inflammatory markers
TNFα (Tumor Necrosis Factor alpha), IL-6 (Interleukin-6), IL-1β (Interleukin-1 beta), and IL-10 (Interleukin-10), it will be measured in serum or plasma.
Time frame: 24 month
Safety Endpoints - UKU Side Effect Rating Scale
Will be conducted on patients and caregivers during all planned visits to ascertain the frequency and severity of adverse events. There will be neurological and physical examinations as well as laboratory testing. Total Score Sum of all 48 item scores (minimum 0; maximum 144), indicates greater overall severity of psychotropic side effects.
Time frame: 24 month
Plan to share: No
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This study is active, not recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Federal University of Latin American Integration