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

Alzheimer's Disease Clinical Trial

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®)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00842816
• Other study ID #: ST101-A001-202
• Status: Completed
• Phase: Phase 2
• First received: February 10, 2009
• Last updated: June 5, 2012
• Start date: February 2009
• Est. completion date: May 2011

Study information

• Verified date: June 2012
• Source: Sonexa Therapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ST101
10 mg; administered once/day
• ST101
60 mg; administered once/day
• ST101
120 mg; administered once/day
• Placebo
placebo tablets to match ST101 tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sonexa Therapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog)		Baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)		Baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	Neuropsychiatric Inventory (NPI)		Baseline, 4 weeks, 8 weeks, 12 weeks	No
Secondary	Alzheimer's Disease Cooperative Study- Clinical Global Impression (ADCS-CGI)		Baseline (severity); 4 weeks, 8 weeks, 12 weeks (change)	No