NCT02925650

Safety, Tolerability, PK and PD of Posiphen® in Subjects With Early Alzheimer's Disease

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamic (PD) Effects of Posiphen® in Subjects With Early Alzheimer's Disease (AD)

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 18 (actual)
• Sponsor: Annovis Bio Inc. · Industry
• Sex: All
• Age: 55 Years – 89 Years
• Healthy volunteers: Not accepted

Summary

This study evaluates the safety and pharmacological effects of 3 different doses of Posiphen® when compared to a placebo, in adult male and female patients with early Alzheimer's disease (AD).

Detailed description

Posiphen®, which was discovered by the US National Institute on Aging (NIA) is a small, orally active, experimental drug that specifically inhibits the synthesis of amyloid precursor protein (APP), Tau and α-Synuclein. It is distinct from other Alzheimer's disease drugs currently in development, because it inhibits the formation of several toxic proteins, rather than removing individual toxic protein after they are produced. Posiphen has potential utility as a disease modifying treatment for AD. The present study will confirm the pharmacokinetics (PK) of Posiphen and its metabolites in plasma and cerebral spinal fluid (CSF). It will also measure the effects of a 23-25 day treatment period with Posiphen on the CSF and plasma levels of a number of biomarkers, inflammatory factors and control proteins. It will also expand the safety data in humans by extending the treatment period from 10 days to a treatment period from 23-25 days. In addition, this study will measure concentrations of various soluble biomarkers in CSF and use the SILK™ assay methods to directly measure the effect of Posiphen on the fractional synthesis rate of Aβ40 in CSF, which will help guide the further development of Posiphen and determine the feasibility of SILK™ in a multicenter trial.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	Posiphen	oral solid dosage form capsule
DRUG	Placebo	oral solid dosage form capsule

Timeline

• Start date: 2017-03-02
• Primary completion: 2021-12-10
• Completion: 2021-12-31
• First posted: 2016-10-06
• Last updated: 2023-05-09
• Results posted: 2023-05-09

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study