UnknownPhase 4

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

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

Lead sponsor

Aristotle University Of Thessaloniki

Assets

Cannabidiol / Homotaurine

Listed sites

Recruiting sites

Enrollment

estimated

Study population

MCI / preclinical Alzheimer’s

Key I/E criterion

•Age 65-85

Primary endpoints

•Mini-Mental State Examination (MMSE)•Montreal Cognitive Assessment (MoCA)•Changes in Functional Cognitive Assessment (FUCAS) score

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID65/06-02-2021

NCT IDNCT05022186

Timeline

Milestones

Study start2021-04-01actual

Study first posted2021-08-26actual

Last update posted2021-08-26actual

Primary completion2022-12-20estimated

Study completion2022-12-20estimated

Assets

Drug assets

Cannabidiol Homotaurine

Study populations

Who this study enrolls

MCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age65 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (20)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Memory

Global cognition

Behavior / neuropsychiatric

Fluid / digital biomarkers

Executive function / language

Neurodegeneration biomarkers

Other (unclassified)

Global cognition

5 endpoints

Primary/protocol endpoint

Changes in Mini Mental State Examination (MMSE) score

Time frame:12-24 months

Mini-Mental State Examination (MMSE)

descriptive

Primary/protocol endpoint

Changes in Montreal Cognitive Assessment (MoCA) score

Time frame:12-24 months

Montreal Cognitive Assessment (MoCA)

descriptive

Primary/protocol endpoint

Changes in Functional Cognitive Assessment (FUCAS) score

Time frame:12-24 months

descriptive

Primary/protocol endpoint

Changes in Clinical Dementia Rating Scale score

Time frame:12-24 months

descriptive

Primary/protocol endpoint

Changes in ADAS-COG

Time frame:12-24 months

ADAS-Cog

descriptive

Memory

6 endpoints

Primary/protocol endpoint

Changes in Letter & Category Verbal Fluency

Time frame:12-24 months

categorical status, descriptive

Primary/protocol endpoint

Changes in Rey Auditory Verbal Learning Test

Time frame:12-24 months

descriptive

Primary/protocol endpoint

Changes in Rey Osterrieth Complex Figure

Time frame:12-24 months

descriptive

Primary/protocol endpoint

Changes in Trail Making Test A & B

Time frame:12-24 months

descriptive

Primary/protocol endpoint

Changes in Rivermead Behavioural Memory Test

Time frame:12-24 months

descriptive

Primary/protocol endpoint

Changes in Symbol-Digit Test

Time frame:12-24 months

descriptive

Executive function / language

1 endpoint

Primary/protocol endpoint

Changes in STROOP Test

Time frame:12-24 months

descriptive

Behavior / neuropsychiatric

3 endpoints

Primary/protocol endpoint

Changes in Geriatric Depression Scale

Time frame:12-24 months

descriptive

Primary/protocol endpoint

Changes in SAST

Time frame:12-24 months

descriptive

Primary/protocol endpoint

Changes in Beck Anxiety Inventory

Time frame:12-24 months

descriptive

Neurodegeneration biomarkers

1 endpoint

Primary/protocol endpoint

Changes in GFAP

Time frame:12-24 months

descriptive

Fluid / digital biomarkers

3 endpoints

Primary/protocol endpoint

Changes in BDNF

Time frame:12-24 months

descriptive

Primary/protocol endpoint

Changes in MDA

Time frame:12-24 months

descriptive

Primary/protocol endpoint

Changes in Tau-protein

Time frame:12-24 months

descriptive

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Changes in Functional Rating Scale for Dementia

Time frame:12-24 months

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.