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

NCT ID: NCT05022186

Last Updated: 2021-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-01

Study Completion Date

2022-12-20

Brief Summary

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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

Detailed Description

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Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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Group receiving Cannabidiol

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

Group Type EXPERIMENTAL

Cannabidiol Oil

Intervention Type DRUG

Patients will use it with specific instructions and they will be monitored at least one time in a month

Group receiving Homotaurine

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

Group Type EXPERIMENTAL

Homotaurine

Intervention Type DRUG

Patients will use it with specific instructions and they will be monitored at least one time in a month

Control group

These patients will not receive treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cannabidiol Oil

Patients will use it with specific instructions and they will be monitored at least one time in a month

Intervention Type DRUG

Homotaurine

Patients will use it with specific instructions and they will be monitored at least one time in a month

Intervention Type DRUG

Other Intervention Names

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CBD 5% Vivimind

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Greek Alzheimer's Association and Related Disorders

OTHER

Sponsor Role collaborator

Aristotle University Of Thessaloniki

OTHER

Sponsor Role lead

Responsible Party

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Magda Tsolaki

Professor of Neurology, Medical School, Aristotle University of Thessaloniki

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Greek Association of Alzheimer's Disease and Related Disorders

Thessaloniki, , Greece

Site Status RECRUITING

Countries

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Greece

Central Contacts

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Thanos Chatzikostopoulos, MSc

Role: CONTACT

6988605949

Facility Contacts

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Thanos Chatzikostopoulos, Psychologist, MSc

Role: primary

6988605949

Magda Tsolaki, Neurologist, Professor

Role: backup

Other Identifiers

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65/06-02-2021

Identifier Type: -

Identifier Source: org_study_id

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