Clinical trial NCT00842816: Preliminary Efficacy and Safety Study of ST101 Plus Aricept in Alzheimer's Disease
Official title: 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®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Dementia
Alzheimer Type Senile Dementia
Cognitive impairment
Lead sponsor: Sonexa Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2009-02-12
Enrollment: 210
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes:
measure: Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Neuropsychiatric Inventory (NPI)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks
measure: Alzheimer's Disease Cooperative Study- Clinical Global Impression (ADCS-CGI)
timeFrame: Baseline (severity); 4 weeks, 8 weeks, 12 weeks (change)
Other outcomes:
Locations:
city: Tucson
country: United States
state: Arizona
city: Costa Mesa
country: United States
state: California
city: Redlands
country: United States
state: California
city: San Diego
country: United States
state: California
city: Walnut Creek
country: United States
state: California
city: Hamden
country: United States
state: Connecticut
city: Brooksville
country: United States
state: Florida
city: Deerfield Beach
country: United States
state: Florida
city: Delray Beach
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: St. Petersburg
country: United States
state: Florida
city: West Palm Beach
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Indianapolis
country: United States
state: Indiana
city: Shreveport
country: United States
state: Louisiana
city: Summit
country: United States
state: New Jersey
city: Toms River
country: United States
state: New Jersey
city: Durham
country: United States
state: North Carolina
city: Columbus
country: United States
state: Ohio
city: Toledo
country: United States
state: Ohio
city: Jenkinton
country: United States
state: Pennsylvania
city: Norristown
country: United States
state: Pennsylvania
city: East Providence
country: United States
state: Rhode Island
city: Houston
country: United States
state: Texas
city: Wichita Falls
country: United States
state: Texas
city: Bennington
country: United States
state: Vermont
city: Kirkland
country: United States
state: Washington
city: Peterborough
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
Study officials:
References: