Status:
COMPLETED
Preliminary Efficacy and Safety Study of ST101 Plus Aricept in Alzheimer's Disease
Lead Sponsor:
Sonexa Therapeutics, Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 ...
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 ar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00842816
Start Date
February 1 2009
End Date
May 1 2011
Last Update
June 7 2012
Active Locations (30)
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1
Tucson, Arizona, United States
2
Costa Mesa, California, United States
3
Redlands, California, United States
4
San Diego, California, United States