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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sonexa Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT00842673

First received: February 10, 2009

Last updated: June 5, 2012

Last verified: June 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	February 10, 2009
Last Updated Date	June 5, 2012
Start Date ^ICMJE	February 2009
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 10, 2009)	Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog) [ Time Frame: Baseline, 4 weeks, 8 weeks,12 weeks ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00842673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 10, 2009)	Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ] Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ] [ Designated as safety issue: No ] Alzheimer's Disease Cooperative Study- Clinical Global Impression (ADCS-CGI) [ Time Frame: Baseline (severity); 4 weeks, 8 weeks, 12 weeks (change) ] [ Designated as safety issue: No ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Preliminary Efficacy and Safety Study of ST101 in Alzheimer's Disease
Official Title ^ICMJE	A Double-Blind Placebo-Controlled Preliminary Study of the Efficacy, Safety and Tolerability of ST101 Tablets in the Treatment of Alzheimer's Disease
Brief Summary	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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Drug: ST101 30 mg; administered once/day Drug: ST101 90 mg; administered once/day Drug: ST101 180 mg; administered once/day Drug: Placebo placebo to match ST101 tablets
Study Arm (s)	Experimental: 1 30 mg ST101 Intervention: Drug: ST101 Experimental: 2 90 mg ST101 Intervention: Drug: ST101 Experimental: 3 180 mg ST101 Intervention: Drug: ST101 Placebo Comparator: 4 Placebo Intervention: Drug: Placebo
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	168
Completion Date	September 2010
Primary Completion Date	September 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Diagnostic evidence of mild to moderate Alzheimer's disease. CT or MRI results within the past 12 months that rule out dementia due to non-Alzheimer's etiology. A reliable and capable caregiver. Exclusion Criteria: Subjects who reside in a skilled nursing facility. Subjects with B12 or folate deficiency. Subjects with chronic hepatic disease. Subjects with a recent history of hematologic/oncologic disorders. Subjects who have experienced a myocardial infarction with the past year. Dementia caused or complicated by other organic disease
Gender	Both
Ages	50 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT00842673
Other Study ID Numbers ^ICMJE	ST101-A001-201
Has Data Monitoring Committee	No
Responsible Party	Sonexa Therapeutics, Inc.
Study Sponsor ^ICMJE	Sonexa Therapeutics, Inc.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Sonexa Therapeutics, Inc.
Verification Date	June 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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