Preliminary Efficacy and Safety Study of ST101 Plus Aricept 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: NCT00842816
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 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 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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 210 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 in Subjects Concurrently Receiving Donepezil (Aricept®)
Study Start Date : February 2009
Primary Completion Date : May 2011
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Donepezil
U.S. FDA Resources

Arm Intervention/treatment
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
Drug: Placebo
placebo tablets 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

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

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.

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): NCT00842816

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Sponsors and Collaborators
Sonexa Therapeutics, Inc.

Responsible Party: Sonexa Therapeutics, Inc. Identifier: NCT00842816     History of Changes
Other Study ID Numbers: ST101-A001-202
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:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents