Cognitive Effects of Vinpocetine in Healthy Adults and Patients With Epilepsy

• Status: Suspended
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Pilot studies in healthy volunteers and in patients with epilepsy to assess the potential efficacy and safety of different dosages of vinpocetine in improving cognition.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Emory University; Stanford University
• Treatments: Vinca Alkaloids; Vinpocetine

Criteria

Inclusion Criteria - Healthy (enrollment of healthy volunteers has been completed)

1. Healthy adults 18-60 years old

2. Proficient English

3. Use of appropriate contraception if woman of childbearing potential. This must include complete abstinence for the duration of the study or use of a barrier method plus one other contraceptive method (e.g. hormonal contraception or intrauterine device, IUD).

Inclusion Criteria -Epilepsy

1. Adults (18-60 years old) with localization related epilepsy

2. Patient is on stable antiepileptic drug therapy for last 2 months and is willing to remain on same therapy for the duration of the study.

3. Proficient English

4. Patient complains of memory problems.

5. Neurological Disorders Depression Index -Epilepsy (NDDI-E) score <16

6. Mini-Mental Status Exam (MMSE) score <22

7. No history of status epilepticus in last year

8. No prior epilepsy surgeries

9. Stable antiepileptic drug (AED) therapy for last 2 months or more and willing not to change for 2 months. Vinpocetine will be stopped and the patient will be withdrawn from the study if marked changes occur in seizures or if other adverse events occur.

10. Use of appropriate contraception if woman of childbearing potential. This must include complete abstinence for the duration of the study or use of a barrier method plus one other contraceptive method (e.g. hormonal contraception or IUD).

Exclusion Criteria -Healthy:

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

2. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the Columbia Suicide Severity Rating Scale (C-SSRS) at Screening.

3. Use of centrally active medications

4. History of allergy to vinpocetine

5. Scores onintelligence quotient (IQ) <80 or Medical College of Georgia (MCG) Paragraph score < 2 standard deviations below norm.

6. Pregnancy or lactation.

Exclusion Criteria- Epilepsy

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

2. Use of centrally active medications

3. History of allergy to vinpocetine

4. Progressive Cerebral Disease (e.g., Alzheimer's disease)

5. Aphasia

6. Taking more than 3 AEDs

7. Pregnancy or lactation

8. Subject has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt), or has suicidal ideation in the past 6 months as indicated by a positive response ('Yes') to either Question 4 or Question 5 of the C-SSRS at Screening.