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

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sonexa Therapeutics, Inc.
• Treatments: Donepezil

Criteria

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.