Dose Escalation Study of Vinpocetine in Healthy Volunteers

Phase I, Open Label, Dose-Escalation Study for Maximum Tolerated Vinpocetine Dose in Healthy Volunteers

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06635746

Enrollment

Registered

2024-10-10

Start date

2025-06-01

Completion date

2026-06-01

Last updated

2024-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fetal Alcohol Spectrum Disorders

Keywords

Cognition, Vinpocetine

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.

Interventions

DRUGVinpocetine

Increasing doses of vinpocetine to assess tolerability.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Adverse Events	Approximately weekly treatments across ~4-6 visits per participant.	Safety Outcome

Contacts

Primary ContactJordan Seliger

jseliger@stanford.edu650-460-9260

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026