# Vinpocetine Mediation of Prior Fetal Alcohol Exposure

> **NIH NIH R61** · STANFORD UNIVERSITY · 2024 · $362,596

## Abstract

Project Summary/Abstract:
There is a compelling need to develop treatments for mental deficiencies from fetal exposure to alcohol. The
impairments are often lifelong and while early intervention services may help reduce some of the effects of
alcohol exposure, there are no cures or adequate specific medical treatments for Fetal Alcohol Spectrum
Disorders (FASD) presently available. Results from studies in humans and animal models suggest that a
disruption in neuronal plasticity is the underlying mechanism responsible for the cognitive impairments caused
by fetal alcohol exposure. Vinpocetine, a phosphodiesterase inhibitor, has been shown in multiple animal
studies, including multiple models of FASD, to improve neuronal plasticity. Therefore, we hypothesize that
vinpocetine may ameliorate the deficits observed in this condition. However, we recently found that the doses
of vinpocetine that are commonly used in humans produce blood levels that are much lower than effective
levels in animal models. Thus, higher doses in humans are needed to produce levels that match effective
levels in animals. Further, dose-response curves are not available from the prior animal studies. Therefore, in
the R61, specific aim 1 is designed to characterize the dose/plasma concentrations response curve for
vinpocetine effects in several FASD animal models. Although vinpocetine is well tolerated in humans at doses
that are typically used, the tolerability of the higher doses is not known. Specific aim 2 in the R61 will determine
the maximum tolerated oral dose of vinpocetine in healthy adult volunteers and develop pilot data on
pharmacokinetic time curve for vinpocetine effects. The data gathered in the proposed series of animal studies
and the Phase I healthy human dose escalation study in the R61 portion will guide specific aim 3, which will
establish a multicenter research team, develop tools for data management and research oversight, develop the
experimental research design, refine a protocol including dosages for the subsequent Phase I and Phase II
studies in the R33, and prepare an operations and procedures manual for the FASD human studies. In the
R33, we propose Phase I and Phase II studies to assess safety and potential cognitive efficacy of doses of
vinpocetine (guided by the findings of the R61 studies) in treating adolescents and adults with FASD.
Therefore, specific aim 4 will assess the safety of doses of vinpocetine in adolescents, while specific aim 5 will
assess the efficacy and safety of vinpocetine to enhance cognition in adolescents and adults with FASD in a
Phase II study. The Phase II study will provide data to determine optimal dose, effect sizes, and best
neuropsychological assessment to be used as the main outcome for a future Phase III trial.

## Key facts

- **NIH application ID:** 10954146
- **Project number:** 1R61AA031291-01A1
- **Recipient organization:** STANFORD UNIVERSITY
- **Principal Investigator:** Julie A Kable
- **Activity code:** R61 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $362,596
- **Award type:** 1
- **Project period:** 2024-09-25 → 2026-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10954146

## Citation

> US National Institutes of Health, RePORTER application 10954146, Vinpocetine Mediation of Prior Fetal Alcohol Exposure (1R61AA031291-01A1). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10954146. Licensed CC0.

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