NCT00842816

Preliminary Efficacy and Safety Study of ST101 Plus Aricept in Alzheimer's Disease

A Double-Blind Placebo-Controlled Preliminary Study of the Efficacy, Safety and Tolerability of ST101 Tablets in the Treatment of Alzheimer's Disease in Subjects Concurrently Receiving Donepezil (Aricept®)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 210 (actual)
• Sponsor: Sonexa Therapeutics, Inc. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the ability of ST101 to improve memory in people with Alzheimer's disease who currently receive 10 mg Aricept® (donepezil) per day. This study also will examine the safety and tolerability of the drug. This study is evaluating 3 different dose levels of ST101 and placebo. Patients will have a 1 in 4 chance of getting placebo. All eligible subjects will be provided with bottles of 10 mg Aricept (donepezil) during the study drug administration part of the study.

Detailed description

Alzheimer's disease (AD) is a progressive and fatal neurological illness. It produces changes in the brain that include loss of cells and accumulation of abnormal protein deposits. Initial symptoms are cognitive, with deficiencies in short-term memory the most common symptom. As the disease progresses so does the severity of cognitive deficiency. Loss of speech and immobility occur in the terminal stages There is no cure for AD and no marketed treatment that modifies the underlying disease process. Available therapies improve some symptoms of AD by increasing brain concentrations of molecules involved in cognition. ST101 differs from marketed therapies in that it has demonstrated two actions in animal research testing. It improves cognition and it also reduces the accumulation of abnormal protein deposits in the brain. These two properties suggest that ST101 may be a promising agent for the treatment of AD. This study is designed as a preliminary dose exploration/proof-of¬concept investigation of the ability of ST101 to improve cognition during 12 weeks of administration.

Conditions

• Alzheimer's Disease

Interventions

Type	Name	Description
DRUG	ST101	10 mg; administered once/day
DRUG	ST101	60 mg; administered once/day
DRUG	ST101	120 mg; administered once/day
DRUG	Placebo	placebo tablets to match ST101 tablets

Timeline

• Start date: 2009-02-01
• Primary completion: 2011-05-01
• Completion: 2011-05-01
• First posted: 2009-02-12
• Last updated: 2012-06-07

Locations

30 sites across 2 countries: United States, Canada