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| Name | Class |
|---|---|
| Greek Alzheimer's Association and Related Disorders | OTHER |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group receiving Cannabidiol | Experimental | These patients will receive cannabidiol 5% without other medication for cognition and depression |
|
| Group receiving Homotaurine | Experimental | These patients will receive Vivimind (homotaurine) without other medication for memory and depression |
|
| Control group | No Intervention | These patients will not receive treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabidiol Oil | Drug | Patients will use it with specific instructions and they will be monitored at least one time in a month |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Thanos Chatzikostopoulos, MSc | Contact | 6988605949 | thachatziko@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Greek Association of Alzheimer's Disease and Related Disorders | Recruiting | Thessaloniki | 54248 | Greece |
Participants' personal data will not be shared with other researchers
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
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| ID | Term |
|---|---|
| D002185 | Cannabidiol |
| C063816 | 5''-hydroxycannabidiol glucoside |
| C001355 | tramiprosate |
| ID | Term |
|---|---|
| D002186 | Cannabinoids |
| D013729 | Terpenes |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
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| Homotaurine | Drug | Patients will use it with specific instructions and they will be monitored at least one time in a month |
|
|
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 |
| D001519 |
| Behavior |