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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SGS742
Sponsored by
Saegis Pharmaceuticals
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer disease, memory, cognition, GABA(B)receptor antagonist

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Dedicated Clinical Research
  • Northwest NeuroSpecialists, PLLC
  • Clinical Trials Incorporated
  • Margolin Brain Institute
  • NervePro Research
  • Center for Neurologic Studies
  • Neuro Therapeutics, Inc.
  • Pacific Research Network, Inc.
  • Affiliated Research Institute
  • San Francisco Clinical Research Center
  • Southern California Clinical Research, Inc.
  • The Mile High Research Center
  • Research Center for Clinical Studies, Inc.
  • Baumel-Eisner Neuromedical Institute, Inc.
  • Bradenton Neurology, Inc.
  • Brain Matters, Inc.
  • Baumel-Eisner Neuromedical Institute
  • Berma Research Group
  • Baumel-Eisner Neuromedical Institute
  • Allied Clinical Trials, The Neurology Group
  • Tukoi Institute for Clinical Research
  • Ocala Neurodiagnostic Center
  • CSI Research
  • DeKalb Neurology Associates, LLC
  • MidAmerica Neuroscience Institute
  • Neurology Department, LSU Health Sciences Center
  • Baystate Medical Center
  • SW Medical Associates
  • Psychopharmacology Research Association of Princeton, P.C.
  • United Health Services Office of Clinical Trials
  • Raleigh Neurology
  • MetroHealth Medical Center
  • University Memory and Aging Center
  • Lynn Health Science Institute
  • Oregon Center for Clinical Investigations, Inc.
  • The Clinical Trial Center, LLC
  • RI Mood & Memory Research Institute
  • Senior Adults Specialty Research, Inc.
  • Claghorn-Lesem Research Clinic, Ltd.
  • Radiant Research San Antonio
  • Texas Medical Research Associates, LLC
  • Grayline Clinical Drug Trials
  • National Clinical Research, Inc.

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
October 7, 2004
Last Updated
December 10, 2009
Sponsor
Saegis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00093951
Brief Title
SGS742 in Patients With Mild to Moderate Alzheimer's Disease (AD)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Saegis Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer disease, memory, cognition, GABA(B)receptor antagonist

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
280 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
SGS742

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013
Country
United States
Facility Name
Dedicated Clinical Research
City
Sun City
State/Province
Arizona
ZIP/Postal Code
85351
Country
United States
Facility Name
Northwest NeuroSpecialists, PLLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Clinical Trials Incorporated
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Margolin Brain Institute
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
NervePro Research
City
Irvine
State/Province
California
ZIP/Postal Code
92618
Country
United States
Facility Name
Center for Neurologic Studies
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
Neuro Therapeutics, Inc.
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
Pacific Research Network, Inc.
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Affiliated Research Institute
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
San Francisco Clinical Research Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
Country
United States
Facility Name
Southern California Clinical Research, Inc.
City
San Marino
State/Province
California
ZIP/Postal Code
91108
Country
United States
Facility Name
The Mile High Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Research Center for Clinical Studies, Inc.
City
Darien
State/Province
Connecticut
ZIP/Postal Code
06820
Country
United States
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06902
Country
United States
Facility Name
Baumel-Eisner Neuromedical Institute, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Bradenton Neurology, Inc.
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34205
Country
United States
Facility Name
Brain Matters, Inc.
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Baumel-Eisner Neuromedical Institute
City
Ft. Lauderdale
State/Province
Florida
ZIP/Postal Code
33321
Country
United States
Facility Name
Berma Research Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Baumel-Eisner Neuromedical Institute
City
Miami Beach
State/Province
Florida
ZIP/Postal Code
33154
Country
United States
Facility Name
Allied Clinical Trials, The Neurology Group
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Facility Name
Tukoi Institute for Clinical Research
City
Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
Ocala Neurodiagnostic Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
City
Palm Springs
State/Province
Florida
ZIP/Postal Code
33461
Country
United States
City
Pompano Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33647
Country
United States
Facility Name
CSI Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
DeKalb Neurology Associates, LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
MidAmerica Neuroscience Institute
City
Lenexa
State/Province
Kansas
ZIP/Postal Code
66214
Country
United States
Facility Name
Neurology Department, LSU Health Sciences Center
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Baystate Medical Center
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01199
Country
United States
Facility Name
SW Medical Associates
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
City
Manchester
State/Province
New Jersey
ZIP/Postal Code
08759
Country
United States
Facility Name
Psychopharmacology Research Association of Princeton, P.C.
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
United Health Services Office of Clinical Trials
City
Johnson City
State/Province
New York
ZIP/Postal Code
13790
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Raleigh Neurology
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
University Memory and Aging Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44120
Country
United States
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43623
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Oregon Center for Clinical Investigations, Inc.
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
City
Bala Cynwyd
State/Province
Pennsylvania
ZIP/Postal Code
19004
Country
United States
Facility Name
The Clinical Trial Center, LLC
City
Jenkintown
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States
Facility Name
RI Mood & Memory Research Institute
City
E Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
City
Madison
State/Province
Tennessee
ZIP/Postal Code
37115
Country
United States
Facility Name
Senior Adults Specialty Research, Inc.
City
Austin
State/Province
Texas
ZIP/Postal Code
78757
Country
United States
Facility Name
Claghorn-Lesem Research Clinic, Ltd.
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Radiant Research San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Texas Medical Research Associates, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78238
Country
United States
Facility Name
Grayline Clinical Drug Trials
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76309
Country
United States
City
Bennington
State/Province
Vermont
ZIP/Postal Code
05201
Country
United States
Facility Name
National Clinical Research, Inc.
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
15451390
Citation
Froestl W, Gallagher M, Jenkins H, Madrid A, Melcher T, Teichman S, Mondadori CG, Pearlman R. SGS742: the first GABA(B) receptor antagonist in clinical trials. Biochem Pharmacol. 2004 Oct 15;68(8):1479-87. doi: 10.1016/j.bcp.2004.07.030.
Results Reference
background

Learn more about this trial

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

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