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

NCT ID: NCT00842816

Last Updated: 2012-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

10 mg ST101

Group Type EXPERIMENTAL

ST101

Intervention Type DRUG

10 mg; administered once/day

2

60 mg ST101

Group Type EXPERIMENTAL

ST101

Intervention Type DRUG

60 mg; administered once/day

3

120 mg ST101

Group Type EXPERIMENTAL

ST101

Intervention Type DRUG

120 mg; administered once/day

4

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo tablets to match ST101 tablets

Interventions

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ST101

10 mg; administered once/day

Intervention Type DRUG

ST101

60 mg; administered once/day

Intervention Type DRUG

ST101

120 mg; administered once/day

Intervention Type DRUG

Placebo

placebo tablets to match ST101 tablets

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sonexa Therapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Tucson, Arizona, United States

Site Status

Costa Mesa, California, United States

Site Status

Redlands, California, United States

Site Status

San Diego, California, United States

Site Status

Walnut Creek, California, United States

Site Status

Hamden, Connecticut, United States

Site Status

Brooksville, Florida, United States

Site Status

Deerfield Beach, Florida, United States

Site Status

Delray Beach, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

St. Petersburg, Florida, United States

Site Status

West Palm Beach, Florida, United States

Site Status

Decatur, Georgia, United States

Site Status

Indianapolis, Indiana, United States

Site Status

Shreveport, Louisiana, United States

Site Status

Summit, New Jersey, United States

Site Status

Toms River, New Jersey, United States

Site Status

Durham, North Carolina, United States

Site Status

Columbus, Ohio, United States

Site Status

Toledo, Ohio, United States

Site Status

Jenkinton, Pennsylvania, United States

Site Status

Norristown, Pennsylvania, United States

Site Status

East Providence, Rhode Island, United States

Site Status

Houston, Texas, United States

Site Status

Wichita Falls, Texas, United States

Site Status

Bennington, Vermont, United States

Site Status

Kirkland, Washington, United States

Site Status

Peterborough, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

Other Identifiers

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ST101-A001-202

Identifier Type: -

Identifier Source: org_study_id

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