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

Phase 4

• Conditions: Mild Cognitive Impairment
• Interventions: Drug: Cannabidiol Oil; Drug: Homotaurine

• Registration Number: NCT05022186
• Lead Sponsor: Aristotle University Of Thessaloniki

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-01
• Study First Submitted: 2021-04-27
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-25
• Last Update Submitted: 2021-08-25
• Study First Posted: 2021-08-26
• Last Update Posted: 2021-08-26
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Group receiving Cannabidiol	Cannabidiol Oil	These patients will receive cannabidiol 5% without other medication for cognition and depression
Group receiving Homotaurine	Homotaurine	These patients will receive Vivimind (homotaurine) without other medication for memory and depression

Primary Outcome Measures

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

Trial Locations

Locations (1)

Greek Association of Alzheimer's Disease and Related Disorders; 🇬🇷 Thessaloniki, Greece