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
  Purpose

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 Intervention Phase
Alzheimer's Disease
Drug: ST101
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Sonexa Therapeutics, Inc.:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale, Cognitive Subscale (ADAS-cog) [ Time Frame: Baseline, 4 weeks, 8 weeks,12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 168
Study Start Date: February 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo
Drug: Placebo
placebo to match ST101 tablets

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842673

Locations
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.
  More Information

No publications provided

Responsible Party: Sonexa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00842673     History of Changes
Other Study ID Numbers: ST101-A001-201
Study First Received: February 10, 2009
Last Updated: June 5, 2012
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by Sonexa Therapeutics, Inc.:
Dementia
Alzheimer Type Senile Dementia
Cognitive impairment

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014