NCT06635746

Brief Summary

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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
1mo left

Started Jun 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress94%
Jun 2025Jun 2026

First Submitted

Initial submission to the registry

October 8, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 10, 2024

Completed
8 months until next milestone

Study Start

First participant enrolled

June 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

October 10, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 8, 2024

Last Update Submit

October 8, 2024

Conditions

Fetal Alcohol Spectrum Disorders

Keywords

CognitionVinpocetine

Outcome Measures

Primary Outcomes (1)

  • Adverse Events

    Safety Outcome

    Approximately weekly treatments across ~4-6 visits per participant.

Study Arms (1)

Vinpocetine

EXPERIMENTAL

Participants will take increasing, single doses of vinpocetine.

Drug: Vinpocetine

Interventions

VinpocetineDRUG

Increasing doses of vinpocetine to assess tolerability.

Vinpocetine

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy adults 18-40 years old.
  • Proficient English.
  • Use of appropriate contraception if woman of childbearing potential.

You may not qualify if:

  • Major medical disease (e.g., epilepsy, diabetes, heart disease, active cancer, depression).
  • Those who score \>18 overall on the BDI-II or \>0 for item #9 (suicidal thoughts) at screening.
  • Use of centrally active medications.
  • History of allergy to vinpocetine.
  • IQ\<80.
  • BMI≥30.
  • Pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Interventions

vinpocetine

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Central Study Contacts

Jordan Seliger

CONTACT

650-460-9260jseliger@stanford.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Neurology

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 10, 2024

Study Start

June 1, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

October 10, 2024

Record last verified: 2024-10