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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05022186
Recruitment Status : Recruiting
First Posted : August 26, 2021
Last Update Posted : August 26, 2021
Sponsor:
Collaborator:
Greek Alzheimer's Association and Related Disorders
Information provided by (Responsible Party):
Magda Tsolaki, 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

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Drug: Cannabidiol Oil Drug: Homotaurine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : April 1, 2021
Estimated Primary Completion Date : December 20, 2022
Estimated Study Completion Date : December 20, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

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 Name: 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 Name: Vivimind

No Intervention: Control group
These patients will not receive treatment



Primary Outcome Measures :
  1. Changes in Mini Mental State Examination (MMSE) score [ Time Frame: 12-24 months ]
  2. Changes in Montreal Cognitive Assessment (MoCA) score [ Time Frame: 12-24 months ]
    Screening test to assess general cognitive function

  3. Changes in Functional Cognitive Assessment (FUCAS) score [ Time Frame: 12-24 months ]
    Measurement of daily functionality

  4. Changes in Letter & Category Verbal Fluency [ Time Frame: 12-24 months ]
    Measurement of verbal fluency, learning, long term memory and categorization skills

  5. Changes in Clinical Dementia Rating Scale score [ Time Frame: 12-24 months ]
    Measurement of general cognitive function

  6. Changes in ADAS-COG [ Time Frame: 12-24 months ]
    Measurement of general cognitive function

  7. Changes in Rey Auditory Verbal Learning Test [ Time Frame: 12-24 months ]
    Screening tool to assess verbal memory and learning

  8. Changes in Rey Osterrieth Complex Figure [ Time Frame: 12-24 months ]
    Screening tool to assess visuospatial memory

  9. Changes in Functional Rating Scale for Dementia [ Time Frame: 12-24 months ]
    Measurement of daily functionality

  10. Changes in Trail Making Test A & B [ Time Frame: 12-24 months ]
    Screening tool to assess working memory and processing speed

  11. Changes in Geriatric Depression Scale [ Time Frame: 12-24 months ]
    Screening tool to assess depressive symptoms

  12. Changes in SAST [ Time Frame: 12-24 months ]
    Screening tool to assess anxiety

  13. Changes in Beck Anxiety Inventory [ Time Frame: 12-24 months ]
    Screening tool to assess anxiety

  14. Changes in Rivermead Behavioural Memory Test [ Time Frame: 12-24 months ]
    Screening tool to assess episodic memory and learning

  15. Changes in STROOP Test [ Time Frame: 12-24 months ]
    Measurement of selective attention and cognitive flexibility

  16. Changes in Symbol-Digit Test [ Time Frame: 12-24 months ]
    Measurement of processing speed, learning and working memory

  17. Changes in BDNF [ Time Frame: 12-24 months ]
    Cerebrospinal Fluid Biomarker

  18. Changes in MDA [ Time Frame: 12-24 months ]
    Cerebrospinal Fluid Biomarker

  19. Changes in GFAP [ Time Frame: 12-24 months ]
    Cerebrospinal Fluid Biomarker

  20. Changes in Tau-protein [ Time Frame: 12-24 months ]
    Cerebrospinal Fluid Biomarker



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05022186


Contacts
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Contact: Thanos Chatzikostopoulos, MSc 6988605949 thachatziko@gmail.com

Locations
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Greece
Greek Association of Alzheimer's Disease and Related Disorders Recruiting
Thessaloniki, Greece, 54248
Contact: Thanos Chatzikostopoulos, Psychologist, MSc    6988605949    thachatziko@gmail.com   
Contact: Magda Tsolaki, Neurologist, Professor       tsolakim1@gmail.com   
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Greek Alzheimer's Association and Related Disorders
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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: August 26, 2021    Key Record Dates
Last Update Posted: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Participants' personal data will not be shared with other researchers

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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, Aristotle University Of Thessaloniki:
cannabidiol
homotaurine
Mild Cognitive Impairment
Cognition
Mental Health
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Cannabidiol
Tramiprosate
Anticonvulsants
GABA Agonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs