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NCT Number: NCT07091747

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Alzheimer Disease (AD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Universidade Federal da Integração Latino-Americana

Foz do Iguaçu, Paraná, 85870-650, Brazil

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Cannabis 50 mg of CBD and 5 mg of THC

Other

Cannabis 50 mg of CBD and 5 mg of THC

Primary outcomes

  1. Mini Mental State Examination

    Time frame: 24 months

    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).

Secondary outcomes

  1. Neuropsychiatric Inventory

    Time frame: 24 months

    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

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

    Time frame: 24 month

    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.

  3. Epworth Sleepiness Scale (ESS )

    Time frame: 24 month

    Evaluates 8 items with scores ranging from 0 to 24, in which scores higher than 10 indicate sleep disturbances.

  4. Specific markers of Alzheimer's disease

    Time frame: 24 month

    The following proteins will be quantified in the cerebrospinal fluid: beta-amyloid 40, beta-amyloid 42, tau protein (fraction 181), and phosphorylated tau protein.

  5. Brain Derived Neurotrophic Factor

    Time frame: 24 month

    It will be measured in serum or plasma

  6. Inflammatory markers

    Time frame: 24 month

    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.

  7. Safety Endpoints - UKU Side Effect Rating Scale

    Time frame: 24 month

    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.

Sponsors and collaborators

Lead sponsor

Federal University of Latin American Integration

Other

Collaborators

  • Conselho Nacional de Desenvolvimento Científico e Tecnológico

Registry information

Acronym: DAZA OPEN

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 29, 2025
Registry last updated
Aug 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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