Dose Escalation Study of Vinpocetine in Healthy Volunteers

NCT ID: NCT06635746

Last Updated: 2024-10-10

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-06-01

Brief Summary

The objective of this study is to determine whether vinpocetine is safe when taken at higher doses.

Detailed Description

The planned study seeks to provide preliminary data to assess the benefits and safety for vinpocetine to address cognitive problems in two groups of patients. One group are patients with epilepsy in whom cognitive problems are common, but there is currently no specific treatment available. Vinpocetine has been shown to improve memory in animals and also has anticonvulsant activity. The other group are people who suffer cognitive/behavioral problems from fetal exposure to alcohol or anticonvulsant drugs. In animals, vinpocetine has been shown to mitigate these deficits. We propose to extend our prior preliminary studies by conducting a Phase I study in healthy volunteers, a Phase I study in adolescents with cognitive impairments from fetal alcohol exposure, then Phase II studies in patients with epilepsy and in adolescents/adults with cognitive impairments from fetal alcohol or antiseizure medication (e.g., valproate) exposure. The proposed investigations are guided by prior PK and PD studies in animals and humans. They are designed to provide data on the dosages needed to provide levels comparable to effective animal studies and provide data on the potential efficacy and safety of vinpocetine in improving cognition in order to direct more definitive randomized trials in the future.

Specific Aim: To determine the maximum tolerated oral dose of vinpocetine in healthy adult volunteers and develop data on pharmacokinetic response curve for vinpocetine effects.

Conditions

Fetal Alcohol Spectrum Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Vinpocetine

Participants will take increasing, single doses of vinpocetine.

Group Type: EXPERIMENTAL

Vinpocetine

Intervention Type: DRUG

Increasing doses of vinpocetine to assess tolerability.

Interventions

Vinpocetine

Increasing doses of vinpocetine to assess tolerability.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy adults 18-40 years old.

2. Proficient English.

3. Use of appropriate contraception if woman of childbearing potential.

Exclusion Criteria

1. Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression).

2. Those who score >18 overall on the BDI-II or >0 for item #9 (suicidal thoughts) at screening.

3. Use of centrally active medications.

4. History of allergy to vinpocetine.

5. IQ<80.

6. BMI≥30.

7. Pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Kimford Jay Meador

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jordan Seliger

Role: CONTACT

jseliger@stanford.edu

650-460-9260

Other Identifiers

R61AA031291

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Protocol: 77615

Identifier Type: -

Identifier Source: org_study_id