Alzheimer Disease (AD)
Conditions
Keywords
Alzheimer's Disease, Cannabidiol (CBD), Tetrahydrocannabinol (THC), Open Label
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.
Interventions
OTHERCannabis 50 mg of CBD and 5 mg of THC
Cannabis 50 mg of CBD and 5 mg of THC
Sponsors
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Federal University of Latin American Integration
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mini Mental State Examination | 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
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life in Alzheimer's Disease scale (QoL-AD) | 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. |
| Epworth Sleepiness Scale (ESS ) | 24 month | Evaluates 8 items with scores ranging from 0 to 24, in which scores higher than 10 indicate sleep disturbances. |
| Specific markers of Alzheimer's disease | 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. |
| Neuropsychiatric Inventory | 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 |
| Inflammatory markers | 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. |
| Safety Endpoints - UKU Side Effect Rating Scale | 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. |
| Brain Derived Neurotrophic Factor | 24 month | It will be measured in serum or plasma |
Countries
Brazil
Outcome results
None listed