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

NCT05022186 | Unknown Phase 4 DMC

• 1 other identifier: 65/06-02-2021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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

Conditions

Mild Cognitive Impairment

Keywords

cannabidiol; homotaurine; Mild Cognitive Impairment; Cognition; Mental Health

Outcome Measures

Primary Outcomes (20)

• Changes in Mini Mental State Examination (MMSE) score

  12-24 months

• Changes in Montreal Cognitive Assessment (MoCA) score

  Screening test to assess general cognitive function

  12-24 months

• Changes in Functional Cognitive Assessment (FUCAS) score

  Measurement of daily functionality

  12-24 months

• Changes in Letter & Category Verbal Fluency

  Measurement of verbal fluency, learning, long term memory and categorization skills

  12-24 months

• Changes in Clinical Dementia Rating Scale score

  Measurement of general cognitive function

  12-24 months

• Changes in ADAS-COG

  Measurement of general cognitive function

  12-24 months

• Changes in Rey Auditory Verbal Learning Test

  Screening tool to assess verbal memory and learning

  12-24 months

• Changes in Rey Osterrieth Complex Figure

  Screening tool to assess visuospatial memory

  12-24 months

• Changes in Functional Rating Scale for Dementia

  Measurement of daily functionality

  12-24 months

• Changes in Trail Making Test A & B

  Screening tool to assess working memory and processing speed

  12-24 months

• Changes in Geriatric Depression Scale

  Screening tool to assess depressive symptoms

  12-24 months

• Changes in SAST

  Screening tool to assess anxiety

  12-24 months

• Changes in Beck Anxiety Inventory

  Screening tool to assess anxiety

  12-24 months

• Changes in Rivermead Behavioural Memory Test

  Screening tool to assess episodic memory and learning

  12-24 months

• Changes in STROOP Test

  Measurement of selective attention and cognitive flexibility

  12-24 months

• Changes in Symbol-Digit Test

  Measurement of processing speed, learning and working memory

  12-24 months

• Changes in BDNF

  Cerebrospinal Fluid Biomarker

  12-24 months

• Changes in MDA

  Cerebrospinal Fluid Biomarker

  12-24 months

• Changes in GFAP

  Cerebrospinal Fluid Biomarker

  12-24 months

• Changes in Tau-protein

  Cerebrospinal Fluid Biomarker

  12-24 months

Study Arms (3)

Group receiving Cannabidiol

EXPERIMENTAL

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

Drug: Cannabidiol Oil

Group receiving Homotaurine

EXPERIMENTAL

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

Drug: Homotaurine

Control group

NO INTERVENTION

These patients will not receive treatment

Interventions

Cannabidiol Oil DRUG

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

Also known as: CBD 5%

Group receiving Cannabidiol

Homotaurine DRUG

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

Also known as: Vivimind

Group receiving Homotaurine

Eligibility Criteria

• Age: 65 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Diagnosis of Mild Cognitive Impairment
• Carry APOE ε4 gene

You may not qualify if:

• Diagnosis of Dementia
• Patients who receive medication for memory or depression
• Patients who do not carry APOE ε4 gene

Sponsors & Collaborators

• Aristotle University Of Thessaloniki: lead
• Greek Alzheimer's Association and Related Disorders: collaborator

Study Sites (1)

Greek Association of Alzheimer's Disease and Related Disorders

Thessaloniki, 54248, Greece

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction; Psychological Well-Being

Interventions

Cannabidiol; 5''-hydroxycannabidiol glucoside; tramiprosate

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Personal Satisfaction; Behavior

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Central Study Contacts

Thanos Chatzikostopoulos, MSc

CONTACT

6988605949; thachatziko@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Medical School, Aristotle University of Thessaloniki

Study Record Dates

• First Submitted: April 27, 2021
• First Posted: August 26, 2021
• Study Start: April 1, 2021
• Primary Completion: December 20, 2022
• Study Completion: December 20, 2022
• Last Updated: August 26, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

GR (1)