Dose Escalation Study of Vinpocetine in Healthy Volunteers

Stanford University

Status and phase: Begins enrollment in 1 month; Phase 1

Conditions: Fetal Alcohol Spectrum Disorders

Treatments: Drug: Vinpocetine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06635746

R61AA031291 (U.S. NIH Grant/Contract)

Protocol: 77615

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Vinpocetine

Experimental group

Description:

Participants will take increasing, single doses of vinpocetine.

Treatment:

Drug: Vinpocetine