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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00842816

Run by

Sonexa Therapeutics, Inc.

People needed

210

Starts

2009-02-01

Expected to finish

2011-05-01

Last updated by the study team

2012-06-07

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Costa Mesa, California, United States
• Study site — Redlands, California, United States
• Study site — San Diego, California, United States
• Study site — Walnut Creek, California, United States
• Study site — Hamden, Connecticut, United States
• Study site — Brooksville, Florida, United States
• Study site — Deerfield Beach, Florida, United States
• Study site — Delray Beach, Florida, United States
• Study site — Orlando, Florida, United States
• Study site — St. Petersburg, Florida, United States
• Study site — West Palm Beach, Florida, United States
• Study site — Decatur, Georgia, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Summit, New Jersey, United States
• Study site — Toms River, New Jersey, United States
• Study site — Durham, North Carolina, United States
• Study site — Columbus, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Jenkinton, Pennsylvania, United States
• Study site — Norristown, Pennsylvania, United States
• Study site — East Providence, Rhode Island, United States
• Study site — Houston, Texas, United States
• Study site — Wichita Falls, Texas, United States

Full record on ClinicalTrials.gov

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