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

Primary Purpose

Mild Cognitive Impairment

Status
Unknown status
Phase
Phase 4
Locations
Greece
Study Type
Interventional
Intervention
Cannabidiol Oil
Homotaurine
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring cannabidiol, homotaurine, Mild Cognitive Impairment, Cognition, Mental Health

Eligibility Criteria

65 Years - 85 Years (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Greek Association of Alzheimer's Disease and Related DisordersRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Group receiving Cannabidiol

Group receiving Homotaurine

Control group

Arm Description

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

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

These patients will not receive treatment

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
April 27, 2021
Last Updated
August 25, 2021
Sponsor
Aristotle University Of Thessaloniki
Collaborators
Greek Alzheimer's Association and Related Disorders
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1. Study Identification

Unique Protocol Identification Number
NCT05022186
Brief Title
The Effects of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment
Official Title
Comparative Randomized Clinical Trial of the Efficacy of Cannabidiol and Homotaurine in Patients With Mild Cognitive Impairment and APOE ε4 Carriers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
December 20, 2022 (Anticipated)
Study Completion Date
December 20, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
Collaborators
Greek Alzheimer's Association and Related Disorders

4. Oversight

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
Data Monitoring Committee
Yes

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
cannabidiol, homotaurine, Mild Cognitive Impairment, Cognition, Mental Health

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group receiving Cannabidiol
Arm Type
Experimental
Arm Description
These patients will receive cannabidiol 5% without other medication for cognition and depression
Arm Title
Group receiving Homotaurine
Arm Type
Experimental
Arm Description
These patients will receive Vivimind (homotaurine) without other medication for memory and depression
Arm Title
Control group
Arm Type
No Intervention
Arm Description
These patients will not receive treatment
Intervention Type
Drug
Intervention Name(s)
Cannabidiol Oil
Other Intervention Name(s)
CBD 5%
Intervention Description
Patients will use it with specific instructions and they will be monitored at least one time in a month
Intervention Type
Drug
Intervention Name(s)
Homotaurine
Other Intervention Name(s)
Vivimind
Intervention Description
Patients will use it with specific instructions and they will be monitored at least one time in a month
Primary Outcome Measure Information:
Title
Changes in Mini Mental State Examination (MMSE) score
Time Frame
12-24 months
Title
Changes in Montreal Cognitive Assessment (MoCA) score
Description
Screening test to assess general cognitive function
Time Frame
12-24 months
Title
Changes in Functional Cognitive Assessment (FUCAS) score
Description
Measurement of daily functionality
Time Frame
12-24 months
Title
Changes in Letter & Category Verbal Fluency
Description
Measurement of verbal fluency, learning, long term memory and categorization skills
Time Frame
12-24 months
Title
Changes in Clinical Dementia Rating Scale score
Description
Measurement of general cognitive function
Time Frame
12-24 months
Title
Changes in ADAS-COG
Description
Measurement of general cognitive function
Time Frame
12-24 months
Title
Changes in Rey Auditory Verbal Learning Test
Description
Screening tool to assess verbal memory and learning
Time Frame
12-24 months
Title
Changes in Rey Osterrieth Complex Figure
Description
Screening tool to assess visuospatial memory
Time Frame
12-24 months
Title
Changes in Functional Rating Scale for Dementia
Description
Measurement of daily functionality
Time Frame
12-24 months
Title
Changes in Trail Making Test A & B
Description
Screening tool to assess working memory and processing speed
Time Frame
12-24 months
Title
Changes in Geriatric Depression Scale
Description
Screening tool to assess depressive symptoms
Time Frame
12-24 months
Title
Changes in SAST
Description
Screening tool to assess anxiety
Time Frame
12-24 months
Title
Changes in Beck Anxiety Inventory
Description
Screening tool to assess anxiety
Time Frame
12-24 months
Title
Changes in Rivermead Behavioural Memory Test
Description
Screening tool to assess episodic memory and learning
Time Frame
12-24 months
Title
Changes in STROOP Test
Description
Measurement of selective attention and cognitive flexibility
Time Frame
12-24 months
Title
Changes in Symbol-Digit Test
Description
Measurement of processing speed, learning and working memory
Time Frame
12-24 months
Title
Changes in BDNF
Description
Cerebrospinal Fluid Biomarker
Time Frame
12-24 months
Title
Changes in MDA
Description
Cerebrospinal Fluid Biomarker
Time Frame
12-24 months
Title
Changes in GFAP
Description
Cerebrospinal Fluid Biomarker
Time Frame
12-24 months
Title
Changes in Tau-protein
Description
Cerebrospinal Fluid Biomarker
Time Frame
12-24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Thanos Chatzikostopoulos, MSc
Phone
6988605949
Email
thachatziko@gmail.com
Facility Information:
Facility Name
Greek Association of Alzheimer's Disease and Related Disorders
City
Thessaloniki
ZIP/Postal Code
54248
Country
Greece
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thanos Chatzikostopoulos, Psychologist, MSc
Phone
6988605949
Email
thachatziko@gmail.com
First Name & Middle Initial & Last Name & Degree
Magda Tsolaki, Neurologist, Professor
Email
tsolakim1@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Participants' personal data will not be shared with other researchers

Learn more about this trial

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

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