NCT01072812

Study of the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Subjects With Amnestic Mild Cognitive Impairment

An Open-Label, Two-Stage Study to Evaluate the Pharmacokinetics and Pharmacodynamics of POSIPHEN® in Plasma and CSF After a 10-Day Treatment Period in Subjects With Amnestic Mild Cognitive Impairment

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Annovis Bio Inc. · Industry
• Sex: All
• Age: 55 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This trial will determine the pharmacokinetics of Posiphen® in both plasma and CSF after a 10-day treatment period with Posiphen® in subjects with amnestic MCI. The effects of this treatment on biomarkers will also be determined in CSF, whole blood, and plasma or serum as primary pharmacodynamic (PD) objectives.

Conditions

• Alzheimer's Disease
• Amnestic Mild Cognitive Impairment

Interventions

Type	Name	Description
DRUG	Posiphen® tartrate capsules	Capsules administered (240 mg/day) for 10 days Capsules administered (160 mg/day) for 10 days

Timeline

• Start date: 2010-02-01
• Primary completion: 2010-07-01
• Completion: 2010-07-01
• First posted: 2010-02-22
• Last updated: 2015-04-22

Locations

1 site across 1 country: United States