Preliminary Efficacy and Safety Study of ST101 Plus Aricept in Alzheimer's Disease
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®)
1 other identifier
interventional
210
2 countries
30
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2009
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 10, 2009
CompletedFirst Posted
Study publicly available on registry
February 12, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2011
CompletedJune 7, 2012
June 1, 2012
2.2 years
February 10, 2009
June 5, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog)
Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary Outcomes (3)
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Baseline, 4 weeks, 8 weeks, 12 weeks
Neuropsychiatric Inventory (NPI)
Baseline, 4 weeks, 8 weeks, 12 weeks
Alzheimer's Disease Cooperative Study- Clinical Global Impression (ADCS-CGI)
Baseline (severity); 4 weeks, 8 weeks, 12 weeks (change)
Study Arms (4)
1
EXPERIMENTAL10 mg ST101
2
EXPERIMENTAL60 mg ST101
3
EXPERIMENTAL120 mg ST101
4
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Unknown Facility
Tucson, Arizona, United States
Unknown Facility
Costa Mesa, California, United States
Unknown Facility
Redlands, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Walnut Creek, California, United States
Unknown Facility
Hamden, Connecticut, United States
Unknown Facility
Brooksville, Florida, United States
Unknown Facility
Deerfield Beach, Florida, United States
Unknown Facility
Delray Beach, Florida, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
St. Petersburg, Florida, United States
Unknown Facility
West Palm Beach, Florida, United States
Unknown Facility
Decatur, Georgia, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Shreveport, Louisiana, United States
Unknown Facility
Summit, New Jersey, United States
Unknown Facility
Toms River, New Jersey, United States
Unknown Facility
Durham, North Carolina, United States
Unknown Facility
Columbus, Ohio, United States
Unknown Facility
Toledo, Ohio, United States
Unknown Facility
Jenkinton, Pennsylvania, United States
Unknown Facility
Norristown, Pennsylvania, United States
Unknown Facility
East Providence, Rhode Island, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Wichita Falls, Texas, United States
Unknown Facility
Bennington, Vermont, United States
Unknown Facility
Kirkland, Washington, United States
Unknown Facility
Peterborough, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Montreal, Quebec, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 10, 2009
First Posted
February 12, 2009
Study Start
February 1, 2009
Primary Completion
May 1, 2011
Study Completion
May 1, 2011
Last Updated
June 7, 2012
Record last verified: 2012-06