Use of a Cannabinoids as a Treatment Strategy for Alzheimer's Disease
NCT Number: NCT06570928
Acronym: DAZACANN
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Alzheimer Disease
Interventions: OTHER: Cannabis|OTHER: Placebo
Sponsor: Federal University of Latin American Integration
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 72
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-13
Completion Date: 2025-03-27
Locations: Federal University of Latin American Integration, Foz do Iguaçu, Paraná, 85870-650, Brazil

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.

Primary Outcome Measures: 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 Outcome Measures: Neuropsychiatric Inventory-Questionnaire (NPI-Q), Assesses neuropsychiatric symptoms in patients with dementia. Evaluates 12 symptoms in the following domains: delusions, hallucinations, agitation, depression, anxiety, euphoria, apathy, disinhibition, irritability, aberrant motor behaviors, nocturnal behavioral disorders, and appetite disorders. The score ranges from 0 to 144., 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), Assesses depressive symptoms in the elderly. The investigators will use the short version, which has a score from 0 to 15. The higher the score, the greater the depressive symptoms., 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 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., 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), Assess symptoms of depression in patients with dementia. Has 19 questions applied to caregiver and patient. The maximum score is 38 points, with scores higher than 10 indicating probable major depression and greater than 18 as major depression., 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 ), Evaluates 8 items with scores ranging from 0 to 24, in which scores higher than 10 indicate sleep disturbances., The participants will be evaluated before starting treatment, and then every 60 days until 180 days are complete, resulting in 4 evaluations.|Specific markers of Alzheimer's disease: Beta-amyloid 40, beta-amyloid 42, tau protein (fraction 181), and phosphorylated tau protein, The following proteins will be quantified in the cerebrospinal fluid: beta-amyloid 40, beta-amyloid 42, tau protein (fraction 181), and phosphorylated tau protein., Collections will be made at the initial time, before the start of treatment and at the end time, after 180 days.|BDNF (Brain Derived Neurotrophic Factor), It will be measured in serum or plasma, Collections will be made at the initial time, before the start of treatment and at the end time, after 180 days.|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, Collections will be made at the initial time, before the start of treatment and at the end time, after 180 days.
Other Outcome Measures: 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., The participants will be evaluated before starting treatment, and then every 60 days until 180 days are complete, resulting in 4 evaluations.