SGS742 in Patients With Mild to Moderate Alzheimer's Disease (AD)

December 10, 2009 updated by: Saegis Pharmaceuticals

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase II Study of the Efficacy and Safety of SGS742 in Subjects With Mild to Moderate Alzheimer's Disease

The purpose of this trial is to determine the effect of a new drug, SGS742, on memory and cognition in patients with mild to moderate Alzheimer's disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

SGS742 is a GABA(B) receptor antagonist. It is an orally active drug and possesses neurochemical and psychopharmacologic features that suggest it could improve memory and cognition in humans. The primary objective of the SGS742 clinical trial will be to determine the effect of SGS742 on memory and cognition in individuals diagnosed with mild to moderate Alzheimer's disease. The duration of the study is 3 months with 5 clinic visits.

Study Type

Interventional

Enrollment

280

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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
      • Sun City, Arizona, United States, 85351
        • Dedicated Clinical Research
      • Tucson, Arizona, United States, 85741
        • Northwest NeuroSpecialists, PLLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • Clinical Trials Incorporated
    • California
      • Fresno, California, United States, 93720
        • Margolin Brain Institute
      • Irvine, California, United States, 92618
        • NervePro Research
      • La Jolla, California, United States, 92037
        • Center for Neurologic Studies
      • Pasadena, California, United States, 91105
        • Neuro Therapeutics, Inc.
      • San Diego, California, United States, 92103
        • Pacific Research Network, Inc.
      • San Diego, California, United States, 92108
        • Affiliated Research Institute
      • San Francisco, California, United States, 94109
        • San Francisco Clinical Research Center
      • San Marino, California, United States, 91108
        • Southern California Clinical Research, Inc.
    • Colorado
      • Denver, Colorado, United States, 80218
        • The Mile High Research Center
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Research Center for Clinical Studies, Inc.
      • Stamford, Connecticut, United States, 06902
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Baumel-Eisner Neuromedical Institute, Inc.
      • Bradenton, Florida, United States, 34205
        • Bradenton Neurology, Inc.
      • Delray Beach, Florida, United States, 33445
        • Brain Matters, Inc.
      • Ft. Lauderdale, Florida, United States, 33321
        • Baumel-Eisner Neuromedical Institute
      • Hialeah, Florida, United States, 33016
        • Berma Research Group
      • Miami, Florida, United States, 33125
        • Allied Clinical Trials, The Neurology Group
      • Miami, Florida, United States, 33161
        • Tukoi Institute for Clinical Research
      • Miami Beach, Florida, United States, 33154
        • Baumel-Eisner Neuromedical Institute
      • Ocala, Florida, United States, 34471
        • Ocala Neurodiagnostic Center
      • Orange City, Florida, United States, 32763
      • Palm Springs, Florida, United States, 33461
      • Pompano Beach, Florida, United States, 33064
      • Tampa, Florida, United States, 33613
      • Tampa, Florida, United States, 33647
    • Georgia
      • Decatur, Georgia, United States, 30033
        • Dekalb Neurology Associates, LLC
      • Decatur, Georgia, United States, 30030
        • CSI Research
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • MidAmerica Neuroscience Institute
    • Louisiana
      • Shreveport, Louisiana, United States, 71103
        • Neurology Department, LSU Health Sciences Center
    • Massachusetts
      • Springfield, Massachusetts, United States, 01199
        • Baystate Medical Center
    • Nevada
      • Las Vegas, Nevada, United States, 89102
        • SW Medical Associates
    • New Jersey
      • Manchester, New Jersey, United States, 08759
      • Princeton, New Jersey, United States, 08540
        • Psychopharmacology Research Association of Princeton, P.C.
    • New York
      • Johnson City, New York, United States, 13790
        • United Health Services Office of Clinical Trials
      • New York, New York, United States, 10021
    • North Carolina
      • Raleigh, North Carolina, United States, 27609
      • Raleigh, North Carolina, United States, 27607
        • Raleigh Neurology
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Cleveland, Ohio, United States, 44120
        • University Memory and Aging Center
      • Toledo, Ohio, United States, 43623
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Lynn Health Science Institute
    • Oregon
      • Eugene, Oregon, United States, 97401
        • Oregon Center for Clinical Investigations, Inc.
      • Medford, Oregon, United States, 97504
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
    • Rhode Island
      • E Providence, Rhode Island, United States, 02914
        • RI Mood & Memory Research Institute
    • Tennessee
      • Madison, Tennessee, United States, 37115
    • Texas
      • Austin, Texas, United States, 78757
        • Senior Adults Specialty Research, Inc.
      • Bellaire, Texas, United States, 77401
        • Claghorn-Lesem Research Clinic, Ltd.
      • San Antonio, Texas, United States, 78238
        • Texas Medical Research Associates, LLC
      • San Antonio, Texas, United States, 78229
        • Radiant Research San Antonio
      • Wichita Falls, Texas, United States, 76309
        • Grayline Clinical Drug Trials
    • Vermont
      • Bennington, Vermont, United States, 05201
    • Virginia
      • Richmond, Virginia, United States, 23294
        • National Clinical Research, Inc.

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

55 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 55 to 90 years of age
  • Diagnosed with mild to moderate Alzheimer's disease
  • Willing caregiver
  • In general good health

Exclusion Criteria:

  • Call 1-877-MY-MEMORY and ask to be referred to a study center located near you for entry criteria information.

Prohibited Meds:

  • Alzheimer's medications (Aricept, Exelon, Remydl, Nemenda)

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
  • Masking: Double

Collaborators and Investigators

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

Sponsor

Saegis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2004

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

October 7, 2004

First Submitted That Met QC Criteria

October 7, 2004

First Posted (Estimate)

October 8, 2004

Study Record Updates

Last Update Posted (Estimate)

December 11, 2009

Last Update Submitted That Met QC Criteria

December 10, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IA0061

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.

Clinical Trials on Alzheimer's Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Vietnam

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe