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A Double-Blind Placebo-Controlled Preliminary Study of the Efficacy, Safety and Tolerability of ST101 Tablets in the Treatment of Alzheimer's Disease
This study will investigate the ability of ST101 to improve memory in people with Alzheimer's disease. 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.
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.
Age
50 - No limit years
Sex
ALL
Healthy Volunteers
No
Costa Mesa, California, United States
Redlands, California, United States
San Diego, California, United States
Walnut Creek, California, United States
Deerfield Beach, Florida, United States
Delray Beach, Florida, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
Indianapolis, Indiana, United States
Shreveport, Louisiana, United States
Start Date
February 1, 2009
Primary Completion Date
September 1, 2010
Completion Date
September 1, 2010
Last Updated
June 7, 2012
168
ACTUAL participants
ST101
DRUG
ST101
DRUG
ST101
DRUG
Placebo
DRUG
Lead Sponsor
Sonexa Therapeutics, Inc.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07033494