Clinical trial NCT05022186: The Effects of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment
Official title: Comparative Randomized Clinical Trial of the Efficacy of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment and APOE ε4 Carriers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Mild Cognitive Impairment
Keywords: cannabidiol
homotaurine
Mild Cognitive Impairment
Cognition
Mental Health
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: Greek Alzheimer's Association and Related Disorders
First posted: 2021-08-26
Enrollment: 90
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Changes in Mini Mental State Examination (MMSE) score
timeFrame: 12-24 months
measure: Changes in Montreal Cognitive Assessment (MoCA) score
timeFrame: 12-24 months
measure: Changes in Functional Cognitive Assessment (FUCAS) score
timeFrame: 12-24 months
measure: Changes in Letter & Category Verbal Fluency
timeFrame: 12-24 months
measure: Changes in Clinical Dementia Rating Scale score
timeFrame: 12-24 months
measure: Changes in ADAS-COG
timeFrame: 12-24 months
measure: Changes in Rey Auditory Verbal Learning Test
timeFrame: 12-24 months
measure: Changes in Rey Osterrieth Complex Figure
timeFrame: 12-24 months
measure: Changes in Functional Rating Scale for Dementia
timeFrame: 12-24 months
measure: Changes in Trail Making Test A & B
timeFrame: 12-24 months
measure: Changes in Geriatric Depression Scale
timeFrame: 12-24 months
measure: Changes in SAST
timeFrame: 12-24 months
measure: Changes in Beck Anxiety Inventory
timeFrame: 12-24 months
measure: Changes in Rivermead Behavioural Memory Test
timeFrame: 12-24 months
measure: Changes in STROOP Test
timeFrame: 12-24 months
measure: Changes in Symbol-Digit Test
timeFrame: 12-24 months
measure: Changes in BDNF
timeFrame: 12-24 months
measure: Changes in MDA
timeFrame: 12-24 months
measure: Changes in GFAP
timeFrame: 12-24 months
measure: Changes in Tau-protein
timeFrame: 12-24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Greek Association of Alzheimer's Disease and Related Disorders
Study officials:
References: