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

Sponsor

Sonexa Therapeutics, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT00842816

Collaborator

(none)

210

Enrollment

Locations

Arms

26.9

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer's Disease	Drug: ST101 Drug: ST101 Drug: ST101 Drug: Placebo	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

210 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

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

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2009

Actual Primary Completion Date :

May 1, 2011

Actual Study Completion Date :

May 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 10 mg ST101	Drug: ST101 10 mg; administered once/day
Experimental: 2 60 mg ST101	Drug: ST101 60 mg; administered once/day
Experimental: 3 120 mg ST101	Drug: ST101 120 mg; administered once/day
Placebo Comparator: 4 Placebo	Drug: Placebo placebo tablets to match ST101 tablets

Outcome Measures

Primary Outcome Measures

Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog) [Baseline, 4 weeks, 8 weeks, 12 weeks]

Secondary Outcome Measures

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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	City	State	Country
1	Tucson	Arizona	United States
2	Costa Mesa	California	United States
3	Redlands	California	United States
4	San Diego	California	United States
5	Walnut Creek	California	United States
6	Hamden	Connecticut	United States
7	Brooksville	Florida	United States
8	Deerfield Beach	Florida	United States
9	Delray Beach	Florida	United States
10	Orlando	Florida	United States
11	St. Petersburg	Florida	United States
12	West Palm Beach	Florida	United States
13	Decatur	Georgia	United States
14	Indianapolis	Indiana	United States
15	Shreveport	Louisiana	United States
16	Summit	New Jersey	United States
17	Toms River	New Jersey	United States
18	Durham	North Carolina	United States
19	Columbus	Ohio	United States
20	Toledo	Ohio	United States
21	Jenkinton	Pennsylvania	United States
22	Norristown	Pennsylvania	United States
23	East Providence	Rhode Island	United States
24	Houston	Texas	United States
25	Wichita Falls	Texas	United States
26	Bennington	Vermont	United States
27	Kirkland	Washington	United States
28	Peterborough	Ontario	Canada
29	Toronto	Ontario	Canada
30	Montreal	Quebec	Canada

Sponsors and Collaborators

Sonexa Therapeutics, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sonexa Therapeutics, Inc.

ClinicalTrials.gov Identifier:

NCT00842816

Other Study ID Numbers:

ST101-A001-202

First Posted:

Feb 12, 2009

Last Update Posted:

Jun 7, 2012

Last Verified:

Jun 1, 2012

Keywords provided by Sonexa Therapeutics, Inc.

Dementia

Alzheimer Type Senile Dementia

Cognitive impairment

Additional relevant MeSH terms:

Alzheimer Disease

Study Results

No Results Posted as of Jun 7, 2012