The Effects of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment

Study Overview
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Brief Summary
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A Randomized Clinical Trial that will compare the effects of Cannabidiol and Homotaurine in cognition and mental health in patients with Mild Cognitive Impairment and APOE ε4 carriers. Ninety patients will be recruited and they will be randomly distributed in three groups. The first group will receive treatment with Cannabidiol 5%, the second group will receive treatment with Vivimind and the third group will not receive any treatment. The three groups will be compared by using an extensive neuropsychological examination and biomarkers' results from cerebrospinal fluid and blood

Official Title
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Comparative Randomized Clinical Trial of the Efficacy of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment and APOE ε4 Carriers

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Drug: Cannabidiol Oil
* Drug: Homotaurine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of Mild Cognitive Impairment Carry APOE ε4 gene Exclusion Criteria: Diagnosis of Dementia Patients who receive medication for memory or depression Patients who do not carry APOE ε4 gene

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group receiving Cannabidiol<br>These patients will receive cannabidiol 5% without other medication for cognition and depression | Drug: Cannabidiol Oil<br>* Patients will use it with specific instructions and they will be monitored at least one time in a month<br>* Other names: CBD 5%;|
| Experimental: Group receiving Homotaurine<br>These patients will receive Vivimind (homotaurine) without other medication for memory and depression | Drug: Homotaurine<br>* Patients will use it with specific instructions and they will be monitored at least one time in a month<br>* Other names: Vivimind;|
| No Intervention: Control group<br>These patients will not receive treatment | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Mini Mental State Examination (MMSE) score |  | 12-24 months | 
| Changes in Montreal Cognitive Assessment (MoCA) score | Screening test to assess general cognitive function | 12-24 months | 
| Changes in Functional Cognitive Assessment (FUCAS) score | Measurement of daily functionality | 12-24 months | 
| Changes in Letter & Category Verbal Fluency | Measurement of verbal fluency, learning, long term memory and categorization skills | 12-24 months | 
| Changes in Clinical Dementia Rating Scale score | Measurement of general cognitive function | 12-24 months | 
| Changes in ADAS-COG | Measurement of general cognitive function | 12-24 months | 
| Changes in Rey Auditory Verbal Learning Test | Screening tool to assess verbal memory and learning | 12-24 months | 
| Changes in Rey Osterrieth Complex Figure | Screening tool to assess visuospatial memory | 12-24 months | 
| Changes in Functional Rating Scale for Dementia | Measurement of daily functionality | 12-24 months | 
| Changes in Trail Making Test A & B | Screening tool to assess working memory and processing speed | 12-24 months | 
| Changes in Geriatric Depression Scale | Screening tool to assess depressive symptoms | 12-24 months | 
| Changes in SAST | Screening tool to assess anxiety | 12-24 months | 
| Changes in Beck Anxiety Inventory | Screening tool to assess anxiety | 12-24 months | 
| Changes in Rivermead Behavioural Memory Test | Screening tool to assess episodic memory and learning | 12-24 months | 
| Changes in STROOP Test | Measurement of selective attention and cognitive flexibility | 12-24 months | 
| Changes in Symbol-Digit Test | Measurement of processing speed, learning and working memory | 12-24 months | 
| Changes in BDNF | Cerebrospinal Fluid Biomarker | 12-24 months | 
| Changes in MDA | Cerebrospinal Fluid Biomarker | 12-24 months | 
| Changes in GFAP | Cerebrospinal Fluid Biomarker | 12-24 months | 
| Changes in Tau-protein | Cerebrospinal Fluid Biomarker | 12-24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cannabidiol, homotaurine, Mild Cognitive Impairment, Cognition, Mental Health