Clinical trial NCT00093951: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Keywords: Alzheimer disease
memory
cognition
GABA(B)receptor antagonist
Lead sponsor: National Institute on Aging (NIA)
Sponsor class: NIH
First posted: 2004-10-08
Enrollment: 280
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

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.

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)

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