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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05022186
• Other study ID #: 65/06-02-2021
• Status: Recruiting
• Phase: Phase 4
• Start date: April 1, 2021
• Est. completion date: December 20, 2022

Study information

• Verified date: August 2021
• Source: Aristotle University Of Thessaloniki
• Contact: Thanos Chatzikostopoulos, MSc
• Phone: 6988605949
• Email: thachatziko[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: December 20, 2022
• Est. primary completion date: December 20, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

Inclusion Criteria:

• Diagnosis of Mild Cognitive Impairment
• Carry APOE e4 gene

Exclusion Criteria:

• Diagnosis of Dementia
• Patients who receive medication for memory or depression
• Patients who do not carry APOE e4 gene

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• Cannabidiol Oil
Patients will use it with specific instructions and they will be monitored at least one time in a month
• Homotaurine
Patients will use it with specific instructions and they will be monitored at least one time in a month

Locations

Country	Name	City	State
Greece	Greek Association of Alzheimer's Disease and Related Disorders	Thessaloniki

Sponsors (2)

Lead Sponsor	Collaborator
Aristotle University Of Thessaloniki	Greek Alzheimer's Association and Related Disorders

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Mini Mental State Examination (MMSE) score		12-24 months
Primary	Changes in Montreal Cognitive Assessment (MoCA) score	Screening test to assess general cognitive function	12-24 months
Primary	Changes in Functional Cognitive Assessment (FUCAS) score	Measurement of daily functionality	12-24 months
Primary	Changes in Letter & Category Verbal Fluency	Measurement of verbal fluency, learning, long term memory and categorization skills	12-24 months
Primary	Changes in Clinical Dementia Rating Scale score	Measurement of general cognitive function	12-24 months
Primary	Changes in ADAS-COG	Measurement of general cognitive function	12-24 months
Primary	Changes in Rey Auditory Verbal Learning Test	Screening tool to assess verbal memory and learning	12-24 months
Primary	Changes in Rey Osterrieth Complex Figure	Screening tool to assess visuospatial memory	12-24 months
Primary	Changes in Functional Rating Scale for Dementia	Measurement of daily functionality	12-24 months
Primary	Changes in Trail Making Test A & B	Screening tool to assess working memory and processing speed	12-24 months
Primary	Changes in Geriatric Depression Scale	Screening tool to assess depressive symptoms	12-24 months
Primary	Changes in SAST	Screening tool to assess anxiety	12-24 months
Primary	Changes in Beck Anxiety Inventory	Screening tool to assess anxiety	12-24 months
Primary	Changes in Rivermead Behavioural Memory Test	Screening tool to assess episodic memory and learning	12-24 months
Primary	Changes in STROOP Test	Measurement of selective attention and cognitive flexibility	12-24 months
Primary	Changes in Symbol-Digit Test	Measurement of processing speed, learning and working memory	12-24 months
Primary	Changes in BDNF	Cerebrospinal Fluid Biomarker	12-24 months
Primary	Changes in MDA	Cerebrospinal Fluid Biomarker	12-24 months
Primary	Changes in GFAP	Cerebrospinal Fluid Biomarker	12-24 months
Primary	Changes in Tau-protein	Cerebrospinal Fluid Biomarker	12-24 months