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

Sponsor
Aristotle University Of Thessaloniki (Other)
Overall Status
Recruiting
CT.gov ID
NCT05022186
Collaborator
Greek Alzheimer's Association and Related Disorders (Other)
90
Enrollment
1
Location
3
Arms
20.6
Anticipated Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Comparative Randomized Clinical Trial of the Efficacy of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment and APOE ε4 Carriers
Actual Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
Dec 20, 2022
Anticipated Study Completion Date :
Dec 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Group receiving Cannabidiol

These patients will receive cannabidiol 5% without other medication for cognition and depression

Drug: Cannabidiol Oil
Patients will use it with specific instructions and they will be monitored at least one time in a month
Other Names:
  • CBD 5%

    		•
    Experimental: Group receiving Homotaurine

    These patients will receive Vivimind (homotaurine) without other medication for memory and depression

    Drug: Homotaurine
    Patients will use it with specific instructions and they will be monitored at least one time in a month
    Other Names:
  • Vivimind

    		•
    No Intervention: Control group

    These patients will not receive treatment

    Outcome Measures

    Primary Outcome Measures

    1. Changes in Mini Mental State Examination (MMSE) score [12-24 months]

    2. Changes in Montreal Cognitive Assessment (MoCA) score [12-24 months]

      Screening test to assess general cognitive function

    3. Changes in Functional Cognitive Assessment (FUCAS) score [12-24 months]

      Measurement of daily functionality

    4. Changes in Letter & Category Verbal Fluency [12-24 months]

      Measurement of verbal fluency, learning, long term memory and categorization skills

    5. Changes in Clinical Dementia Rating Scale score [12-24 months]

      Measurement of general cognitive function

    6. Changes in ADAS-COG [12-24 months]

      Measurement of general cognitive function

    7. Changes in Rey Auditory Verbal Learning Test [12-24 months]

      Screening tool to assess verbal memory and learning

    8. Changes in Rey Osterrieth Complex Figure [12-24 months]

      Screening tool to assess visuospatial memory

    9. Changes in Functional Rating Scale for Dementia [12-24 months]

      Measurement of daily functionality

    10. Changes in Trail Making Test A & B [12-24 months]

      Screening tool to assess working memory and processing speed

    11. Changes in Geriatric Depression Scale [12-24 months]

      Screening tool to assess depressive symptoms

    12. Changes in SAST [12-24 months]

      Screening tool to assess anxiety

    13. Changes in Beck Anxiety Inventory [12-24 months]

      Screening tool to assess anxiety

    14. Changes in Rivermead Behavioural Memory Test [12-24 months]

      Screening tool to assess episodic memory and learning

    15. Changes in STROOP Test [12-24 months]

      Measurement of selective attention and cognitive flexibility

    16. Changes in Symbol-Digit Test [12-24 months]

      Measurement of processing speed, learning and working memory

    17. Changes in BDNF [12-24 months]

      Cerebrospinal Fluid Biomarker

    18. Changes in MDA [12-24 months]

      Cerebrospinal Fluid Biomarker

    19. Changes in GFAP [12-24 months]

      Cerebrospinal Fluid Biomarker

    20. Changes in Tau-protein [12-24 months]

      Cerebrospinal Fluid Biomarker

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Greek Association of Alzheimer's Disease and Related Disorders Thessaloniki Greece 54248

    Sponsors and Collaborators

    • Aristotle University Of Thessaloniki
    • Greek Alzheimer's Association and Related Disorders

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Magda Tsolaki, Professor of Neurology, Medical School, Aristotle University of Thessaloniki, Aristotle University Of Thessaloniki
    ClinicalTrials.gov Identifier:
    NCT05022186
    Other Study ID Numbers:
    • 65/06-02-2021
    First Posted:
    Aug 26, 2021
    Last Update Posted:
    Aug 26, 2021
    Last Verified:
    Aug 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Magda Tsolaki, Professor of Neurology, Medical School, Aristotle University of Thessaloniki, Aristotle University Of Thessaloniki
    cannabidiol
    homotaurine
    Mild Cognitive Impairment
    Cognition
    Mental Health
    Additional relevant MeSH terms:
    Cognitive Dysfunction
    Cannabidiol
    Tramiprosate

    Study Results

    No Results Posted as of Aug 26, 2021