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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
90
Patients will use it with specific instructions and they will be monitored at least one time in a month
Patients will use it with specific instructions and they will be monitored at least one time in a month
Greek Association of Alzheimer's Disease and Related Disorders
Thessaloniki, Greece
RECRUITINGChanges in Mini Mental State Examination (MMSE) score
Time frame: 12-24 months
Changes in Montreal Cognitive Assessment (MoCA) score
Screening test to assess general cognitive function
Time frame: 12-24 months
Changes in Functional Cognitive Assessment (FUCAS) score
Measurement of daily functionality
Time frame: 12-24 months
Changes in Letter & Category Verbal Fluency
Measurement of verbal fluency, learning, long term memory and categorization skills
Time frame: 12-24 months
Changes in Clinical Dementia Rating Scale score
Measurement of general cognitive function
Time frame: 12-24 months
Changes in ADAS-COG
Measurement of general cognitive function
Time frame: 12-24 months
Changes in Rey Auditory Verbal Learning Test
Screening tool to assess verbal memory and learning
Time frame: 12-24 months
Changes in Rey Osterrieth Complex Figure
Screening tool to assess visuospatial memory
Time frame: 12-24 months
Changes in Functional Rating Scale for Dementia
Measurement of daily functionality
Time frame: 12-24 months
Changes in Trail Making Test A & B
Screening tool to assess working memory and processing speed
Time frame: 12-24 months
Changes in Geriatric Depression Scale
Screening tool to assess depressive symptoms
Time frame: 12-24 months
Changes in SAST
Screening tool to assess anxiety
Time frame: 12-24 months
Changes in Beck Anxiety Inventory
Screening tool to assess anxiety
Time frame: 12-24 months
Changes in Rivermead Behavioural Memory Test
Screening tool to assess episodic memory and learning
Time frame: 12-24 months
Changes in STROOP Test
Measurement of selective attention and cognitive flexibility
Time frame: 12-24 months
Changes in Symbol-Digit Test
Measurement of processing speed, learning and working memory
Time frame: 12-24 months
Changes in BDNF
Cerebrospinal Fluid Biomarker
Time frame: 12-24 months
Changes in MDA
Cerebrospinal Fluid Biomarker
Time frame: 12-24 months
Changes in GFAP
Cerebrospinal Fluid Biomarker
Time frame: 12-24 months
Changes in Tau-protein
Cerebrospinal Fluid Biomarker
Time frame: 12-24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.