Bob DeMarco Alzheimer's Reading Room

Sunday, February 15, 2009

Clinical Trial: Efficacy and Safety Study of ST101 Plus Aricept in Alzheimer's Disease


This study is not yet open for participant recruitment; however, it is expected to start soon and the locations are already up and listed. If you are interested you might want to check the locations and make contact now.

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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Eligibility

Ages Eligible for Study: 50 Years and older
Genders Eligible for Study: Both
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

Locations
Go here to check the list of participating locations.

Responsible Party: Sonexa Therapeutics, Inc. ( Barbara Finn/Sr. VP Regulatory Affairs and QA )
Study ID Numbers: ST101-A001-202
Study First Received: February 10, 2009
Last Updated: February 11, 2009
ClinicalTrials.gov Identifier: NCT00842816 history of changes since first registered
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Alzheimer disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Information provided by Sonexa Therapeutics, Inc.

Previously on the Alzheimer's Reading Room