Ignite Creation Date:
2024-10-25 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06570928
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-19
Brief Title:
Use of a Cannabinoids as a Treatment Strategy for Alzheimers Disease
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Use of a Product Containing the Cannabinoids CBD and THC as a Treatment Strategy for Alzheimers Disease - Clinical Trial Alzheimers Disease and Cannabis DAZACANN
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DAZACANN
Brief Summary:
Brief Summary
The objective of the study is to evaluate the effect of cannabinoids on Alzheimers Disease This is a double-blind randomized placebo-controlled clinical trial The study aims to recruit patients of both sexes diagnosed with Alzheimers 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 Alzheimers 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 Alzheimers Disease
Participants will use a compound containing CBDTHC 505 mgmL administered as 02 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 Alzheimers Disease and inflammatory markers
The objective of the study is to evaluate the effect of cannabinoids on Alzheimers Disease This is a double-blind randomized placebo-controlled clinical trial The study aims to recruit patients of both sexes diagnosed with Alzheimers 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 Alzheimers 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 Alzheimers Disease
Participants will use a compound containing CBDTHC 505 mgmL administered as 02 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 Alzheimers Disease and inflammatory markers
Detailed Description:
Alzheimers 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 Alzheimers 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 PortugueseBrazil 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 290 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 Students 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 Friedmans 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
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 Alzheimers 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 PortugueseBrazil 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 290 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 Students 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 Friedmans 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None