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

Aristotle University Of Thessaloniki

Status and phase: Unknown; Phase 4

Conditions: Mild Cognitive Impairment

Treatments: Drug: Homotaurine; Drug: Cannabidiol Oil

Study type: Interventional

Funder types: Other

Identifiers

NCT05022186

65/06-02-2021

Details and patient eligibility

About

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

Enrollment: 90 estimated patients

Sex: All

Ages: 65 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

---

90 participants in 3 patient groups

Group receiving Cannabidiol

Experimental group

Description:

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

Treatment:

Drug: Cannabidiol Oil

Group receiving Homotaurine

Experimental group

Description:

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

Treatment:

Drug: Homotaurine

Control group

No Intervention group

Description:

These patients will not receive treatment