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

February 10, 2009
June 5, 2012
February 2009
September 2010   (final data collection date for primary outcome measure)
Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog) [ Time Frame: Baseline, 4 weeks, 8 weeks,12 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00842673 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Preliminary Efficacy and Safety Study of ST101 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

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
168
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00842673
ST101-A001-201
No
Sonexa Therapeutics, Inc.
Sonexa Therapeutics, Inc.
Not Provided
Not Provided
Sonexa Therapeutics, Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP