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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00842673
Recruitment Status : Completed
First Posted : February 12, 2009
Last Update Posted : June 7, 2012
Information provided by (Responsible Party):
Sonexa Therapeutics, Inc.

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ST101 Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 168 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-Blind Placebo-Controlled Preliminary Study of the Efficacy, Safety and Tolerability of ST101 Tablets in the Treatment of Alzheimer's Disease
Study Start Date : February 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1
30 mg ST101
Drug: ST101
30 mg; administered once/day

Experimental: 2
90 mg ST101
Drug: ST101
90 mg; administered once/day

Experimental: 3
180 mg ST101
Drug: ST101
180 mg; administered once/day

Placebo Comparator: 4
Drug: Placebo
placebo to match ST101 tablets

Primary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog) [ Time Frame: Baseline, 4 weeks, 8 weeks,12 weeks ]

Secondary Outcome Measures :
  1. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
  2. Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks ]
  3. Alzheimer's Disease Cooperative Study- Clinical Global Impression (ADCS-CGI) [ Time Frame: Baseline (severity); 4 weeks, 8 weeks, 12 weeks (change) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00842673

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United States, California
Costa Mesa, California, United States
Redlands, California, United States
San Diego, California, United States
Walnut Creek, California, United States
United States, Florida
Deerfield Beach, Florida, United States
Delray Beach, Florida, United States
Orlando, Florida, United States
West Palm Beach, Florida, United States
United States, Indiana
Indianapolis, Indiana, United States
United States, Louisiana
Shreveport, Louisiana, United States
United States, North Carolina
Durham, North Carolina, United States
United States, Ohio
Toledo, Ohio, United States
United States, Pennsylvania
Jenkinton, Pennsylvania, United States
United States, Texas
Wichita Falls, Texas, United States
United States, Vermont
Bennington, Vermont, United States
Canada, Ontario
Peterborough, Ontario, Canada
Toronto, Ontario, Canada
Canada, Quebec
Montreal, Quebec, Canada
Sponsors and Collaborators
Sonexa Therapeutics, Inc.
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Responsible Party: Sonexa Therapeutics, Inc. Identifier: NCT00842673    
Other Study ID Numbers: ST101-A001-201
First Posted: February 12, 2009    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012
Keywords provided by Sonexa Therapeutics, Inc.:
Alzheimer Type Senile Dementia
Cognitive impairment
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders