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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00093951
• Other study ID #: IA0061
• Status: Completed
• Phase: Phase 2
• First received: October 7, 2004
• Last updated: December 10, 2009
• Start date: April 2004
• Est. completion date: September 2007

Study information

• Verified date: February 2009
• Source: National Institute on Aging (NIA)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• SGS742

Locations

Country	Name	City	State
United States	Senior Adults Specialty Research, Inc.	Austin	Texas
United States	Claghorn-Lesem Research Clinic, Ltd.	Bellaire	Texas
United States	Baumel-Eisner Neuromedical Institute, Inc.	Boca Raton	Florida
United States	Bradenton Neurology, Inc.	Bradenton	Florida
United States	MetroHealth Medical Center	Cleveland	Ohio
United States	University Memory and Aging Center	Cleveland	Ohio
United States	Research Center for Clinical Studies, Inc.	Darien	Connecticut
United States	CSI Research	Decatur	Georgia
United States	DeKalb Neurology Associates, LLC	Decatur	Georgia
United States	Brain Matters, Inc.	Delray Beach	Florida
United States	The Mile High Research Center	Denver	Colorado
United States	RI Mood & Memory Research Institute	E Providence	Rhode Island
United States	Oregon Center for Clinical Investigations, Inc.	Eugene	Oregon
United States	Margolin Brain Institute	Fresno	California
United States	Baumel-Eisner Neuromedical Institute	Ft. Lauderdale	Florida
United States	Berma Research Group	Hialeah	Florida
United States	NervePro Research	Irvine	California
United States	The Clinical Trial Center, LLC	Jenkintown	Pennsylvania
United States	United Health Services Office of Clinical Trials	Johnson City	New York
United States	Center for Neurologic Studies	La Jolla	California
United States	SW Medical Associates	Las Vegas	Nevada
United States	MidAmerica Neuroscience Institute	Lenexa	Kansas
United States	Clinical Trials Incorporated	Little Rock	Arkansas
United States	Allied Clinical Trials, The Neurology Group	Miami	Florida
United States	Tukoi Institute for Clinical Research	Miami	Florida
United States	Baumel-Eisner Neuromedical Institute	Miami Beach	Florida
United States	Ocala Neurodiagnostic Center	Ocala	Florida
United States	Lynn Health Science Institute	Oklahoma City	Oklahoma
United States	Neuro Therapeutics, Inc.	Pasadena	California
United States	Psychopharmacology Research Association of Princeton, P.C.	Princeton	New Jersey
United States	Raleigh Neurology	Raleigh	North Carolina
United States	National Clinical Research, Inc.	Richmond	Virginia
United States	Radiant Research San Antonio	San Antonio	Texas
United States	Texas Medical Research Associates, LLC	San Antonio	Texas
United States	Affiliated Research Institute	San Diego	California
United States	Pacific Research Network, Inc.	San Diego	California
United States	San Francisco Clinical Research Center	San Francisco	California
United States	Southern California Clinical Research, Inc.	San Marino	California
United States	Neurology Department, LSU Health Sciences Center	Shreveport	Louisiana
United States	Baystate Medical Center	Springfield	Massachusetts
United States	Dedicated Clinical Research	Sun City	Arizona
United States	Northwest NeuroSpecialists, PLLC	Tucson	Arizona
United States	Grayline Clinical Drug Trials	Wichita Falls	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Saegis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation