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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sonexa Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT00842816
First received: February 10, 2009
Last updated: June 5, 2012
Last verified: June 2012
History of Changes
  Purpose

This study will investigate the ability of ST101 to improve memory in people with Alzheimer's disease who currently receive 10 mg Aricept® (donepezil) per day. 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. All eligible subjects will be provided with bottles of 10 mg Aricept (donepezil) during the study drug administration part of the study.


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 in Subjects Concurrently Receiving Donepezil (Aricept®)

Resource links provided by NLM:

U.S. FDA Resources

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: 210
Study Start Date: February 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
10 mg ST101
 Drug: ST101
10 mg; administered once/day
Experimental: 2
60 mg ST101
 Drug: ST101
60 mg; administered once/day
Experimental: 3
120 mg ST101
 Drug: ST101
120 mg; administered once/day
Placebo Comparator: 4
Placebo
 Drug: Placebo
placebo tablets 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:

  • Subjects must be receiving concurrent treatment with 10 mg/day of Aricept (donepezil). The dose shall have been stable for three (3) months (90 days) prior to Screening.
  • Diagnostic evidence of Moderate to Moderately Severe Probable Alzheimer's disease
  • CT or MRI results within the past 18 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00842816

  Show 30 Study Locations
Sponsors and Collaborators
Sonexa Therapeutics, Inc.
  More Information

No publications provided

Responsible Party: Sonexa Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT00842816     History of Changes
Other Study ID Numbers: ST101-A001-202
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 May 19, 2013