Use of a Cannabinoids as a Treatment Strategy for Alzheimer's Disease
72 patients around the world
Available in Brazil
Alzheimer's disease (AD) is closely linked to the accumulation of neurotoxins derived
from Aβ and tau, leading to cognitive impairment. This project posits that an imbalance
in the endocannabinoid system occurs in an AD-dependent manner. Reported connections
between dementia, inflammation, Aβ, and alterations in the cannabinoid system in
experimental models of AD support this hypothesis. Cannabinoids may restore baseline
brain function while avoiding major side effects. Despite extensive research into new AD
therapies, no significant improvement has been achieved recently, and there is little
consensus on how scientists will innovate to develop a new treatment. Cannabinoid-based
therapy has emerged as crucial for the treatment of many diseases considered incurable.
The expected results of this project will provide important insights into the ability of
cannabinoids to counteract neurochemical imbalance during AD progression, thereby
improving memory performance and affecting inflammation as well as Aβ and tau levels.
The key point is to provide evidence that cannabinoids can serve as an efficient
treatment for AD while avoiding major side effects. The aim of this project is to
determine the effect of cannabinoids in AD patients, evaluating memory and cognition. It
is expected that the results will establish that cannabinoids are critical for restoring
the baseline function of the endocannabinoid system in AD brains and their beneficial
effects. This project may be instrumental in validating new therapeutic approaches for
AD.
To evaluate the pharmacological activity of low doses of CBD, a double-blind, randomized,
placebo-controlled clinical trial will be conducted for a duration of 6 months. A
baseline assessment will be performed, and patients will be evaluated every 60 days for a
period of 6 months, totaling 4 evaluation sessions. For this purpose, the following
questionnaires will be applied: Mini-Mental State Examination (MMSE), Neuropsychiatric
Inventory (NPI), Geriatric Depression Scale (GDS), Alzheimer's Disease Quality of Life
version patient, version caregiver and caregiver-patient version, Cornell Depression in
Dementia Scale, and Epworth Sleepiness Scale. All questionnaires are references in their
assessment domains and are validated for Portuguese/Brazil. In addition to the evaluation
scales, biological material will be collected with blood and cerebrospinal fluid samples
at baseline and at the end (after 6 months). The following analytes will be measured in
the CSF: BDNF, beta-amyloid, Tau protein, TNFα, IL-6, IL-1β, and IL-10. During the
research and data collection, patients' conventional treatments will not be altered.
Statistical Analysis Plan SPSS software, version 29.0 will be used for the analyses. For
quantitative data, the Shapiro-Wilk distribution test will be performed. Potential
associations between qualitative variables will be analyzed using the Chi-Square test
with adjusted residual analysis (χ²). The means (±SD) will be analyzed using the
Student's t test for independent samples. Medians [IQR] will be calculated using the
Mann-Whitney U test. Paired quantitative data will be compared individually by group
across the analyzed time points using Friedman's ANOVA test.
A generalized estimating equations (GEE) model, linear or with log-gamma link, and
Bonferroni correction will be used to simultaneously evaluate quantitative parameters
over time and between groups. For these descriptive analyses, data will be presented as
means ± standard errors (±SEM). Pearson or Spearman correlations can be performed between
variables of interest. For all analyses, the significance level will be set at 5%.
Federal University of Latin American Integration
1Research sites
72Patients around the world
This study is for people with
Alzheimer disease
Requirements for the patient
From 60 Years
All Gender
Medical requirements
Sites
Universidad Federal de Integración Latinoamericana
Recruiting
Av. Tarquínio Joslin dos Santos, 1000 - Lot. Universitario das Americas, Foz do Iguaçu - PR, 85870-650, Brazil
StudyDAZACANN
SponsorFederal University of Latin American Integration