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®)

Sponsors

Lead Sponsor: Sonexa Therapeutics, Inc.

Source Sonexa Therapeutics, Inc.
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.

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.

Overall Status Completed
Start Date February 2009
Completion Date May 2011
Primary Completion Date May 2011
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog) Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary Outcome
Measure Time Frame
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)
Enrollment 210
Condition
Intervention

Intervention Type: Drug

Intervention Name: ST101

Description: 10 mg; administered once/day

Arm Group Label: 1

Intervention Type: Drug

Intervention Name: ST101

Description: 60 mg; administered once/day

Arm Group Label: 2

Intervention Type: Drug

Intervention Name: ST101

Description: 120 mg; administered once/day

Arm Group Label: 3

Intervention Type: Drug

Intervention Name: Placebo

Description: placebo tablets to match ST101 tablets

Arm Group Label: 4

Eligibility

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.

Gender: All

Minimum Age: 50 Years

Maximum Age: N/A

Healthy Volunteers: No

Location
Facility:
| Tucson, Arizona, United States
| Costa Mesa, California, United States
| Redlands, California, United States
| San Diego, California, United States
| Walnut Creek, California, United States
| Hamden, Connecticut, United States
| Brooksville, Florida, United States
| Deerfield Beach, Florida, United States
| Delray Beach, Florida, United States
| Orlando, Florida, United States
| St. Petersburg, Florida, United States
| West Palm Beach, Florida, United States
| Decatur, Georgia, United States
| Indianapolis, Indiana, United States
| Shreveport, Louisiana, United States
| Summit, New Jersey, United States
| Toms River, New Jersey, United States
| Durham, North Carolina, United States
| Columbus, Ohio, United States
| Toledo, Ohio, United States
| Jenkinton, Pennsylvania, United States
| Norristown, Pennsylvania, United States
| East Providence, Rhode Island, United States
| Houston, Texas, United States
| Wichita Falls, Texas, United States
| Bennington, Vermont, United States
| Kirkland, Washington, United States
| Peterborough, Ontario, Canada
| Toronto, Ontario, Canada
| Montreal, Quebec, Canada
Location Countries

Canada

United States

Verification Date

June 2012

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Label: 1

Type: Experimental

Description: 10 mg ST101

Label: 2

Type: Experimental

Description: 60 mg ST101

Label: 3

Type: Experimental

Description: 120 mg ST101

Label: 4

Type: Placebo Comparator

Description: Placebo

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Source: ClinicalTrials.gov