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

August 25, 2021 updated by: Magda Tsolaki, Aristotle University Of Thessaloniki

Comparative Randomized Clinical Trial of the Efficacy of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment and APOE ε4 Carriers

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Greece
      • Thessaloniki, Greece, 54248
        • Recruiting
        • Greek Association of Alzheimer's Disease and Related Disorders
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Mini Mental State Examination (MMSE) score
Time Frame: 12-24 months
12-24 months
Changes in Montreal Cognitive Assessment (MoCA) score
Time Frame: 12-24 months
Screening test to assess general cognitive function
12-24 months
Changes in Functional Cognitive Assessment (FUCAS) score
Time Frame: 12-24 months
Measurement of daily functionality
12-24 months
Changes in Letter & Category Verbal Fluency
Time Frame: 12-24 months
Measurement of verbal fluency, learning, long term memory and categorization skills
12-24 months
Changes in Clinical Dementia Rating Scale score
Time Frame: 12-24 months
Measurement of general cognitive function
12-24 months
Changes in ADAS-COG
Time Frame: 12-24 months
Measurement of general cognitive function
12-24 months
Changes in Rey Auditory Verbal Learning Test
Time Frame: 12-24 months
Screening tool to assess verbal memory and learning
12-24 months
Changes in Rey Osterrieth Complex Figure
Time Frame: 12-24 months
Screening tool to assess visuospatial memory
12-24 months
Changes in Functional Rating Scale for Dementia
Time Frame: 12-24 months
Measurement of daily functionality
12-24 months
Changes in Trail Making Test A & B
Time Frame: 12-24 months
Screening tool to assess working memory and processing speed
12-24 months
Changes in Geriatric Depression Scale
Time Frame: 12-24 months
Screening tool to assess depressive symptoms
12-24 months
Changes in SAST
Time Frame: 12-24 months
Screening tool to assess anxiety
12-24 months
Changes in Beck Anxiety Inventory
Time Frame: 12-24 months
Screening tool to assess anxiety
12-24 months
Changes in Rivermead Behavioural Memory Test
Time Frame: 12-24 months
Screening tool to assess episodic memory and learning
12-24 months
Changes in STROOP Test
Time Frame: 12-24 months
Measurement of selective attention and cognitive flexibility
12-24 months
Changes in Symbol-Digit Test
Time Frame: 12-24 months
Measurement of processing speed, learning and working memory
12-24 months
Changes in BDNF
Time Frame: 12-24 months
Cerebrospinal Fluid Biomarker
12-24 months
Changes in MDA
Time Frame: 12-24 months
Cerebrospinal Fluid Biomarker
12-24 months
Changes in GFAP
Time Frame: 12-24 months
Cerebrospinal Fluid Biomarker
12-24 months
Changes in Tau-protein
Time Frame: 12-24 months
Cerebrospinal Fluid Biomarker
12-24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aristotle University Of Thessaloniki

Collaborators

Greek Alzheimer's Association and Related Disorders

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

December 20, 2022

Study Completion (Anticipated)

December 20, 2022

Study Registration Dates

First Submitted

April 27, 2021

First Submitted That Met QC Criteria

August 25, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 26, 2021

Last Update Submitted That Met QC Criteria

August 25, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 65/06-02-2021

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Participants' personal data will not be shared with other researchers

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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