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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Aristotle University Of Thessaloniki

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 20, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 26, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings