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

June 5, 2012 updated by: Sonexa Therapeutics, Inc.

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®)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

210

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Peterborough, Ontario, Canada
      • Toronto, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Costa Mesa, California, United States
      • Redlands, California, United States
      • San Diego, California, United States
      • Walnut Creek, California, United States
    • Connecticut
      • Hamden, Connecticut, United States
    • Florida
      • 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
    • Georgia
      • Decatur, Georgia, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Louisiana
      • Shreveport, Louisiana, United States
    • New Jersey
      • Summit, New Jersey, United States
      • Toms River, New Jersey, United States
    • North Carolina
      • Durham, North Carolina, United States
    • Ohio
      • Columbus, Ohio, United States
      • Toledo, Ohio, United States
    • Pennsylvania
      • Jenkinton, Pennsylvania, United States
      • Norristown, Pennsylvania, United States
    • Rhode Island
      • East Providence, Rhode Island, United States
    • Texas
      • Houston, Texas, United States
      • Wichita Falls, Texas, United States
    • Vermont
      • Bennington, Vermont, United States
    • Washington
      • Kirkland, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Alzheimer's Disease Assessment Scale, cognitive subscale (ADAS-cog)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Baseline, 4 weeks, 8 weeks, 12 weeks
Neuropsychiatric Inventory (NPI)
Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Baseline, 4 weeks, 8 weeks, 12 weeks
Alzheimer's Disease Cooperative Study- Clinical Global Impression (ADCS-CGI)
Time Frame: Baseline (severity); 4 weeks, 8 weeks, 12 weeks (change)
Baseline (severity); 4 weeks, 8 weeks, 12 weeks (change)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sonexa Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

February 10, 2009

First Submitted That Met QC Criteria

February 11, 2009

First Posted (Estimate)

February 12, 2009

Study Record Updates

Last Update Posted (Estimate)

June 7, 2012

Last Update Submitted That Met QC Criteria

June 5, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ST101-A001-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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