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

This study has been completed.

First Received: October 7, 2004 Last Updated: February 20, 2009 History of Changes

Sponsored by:	Saegis Pharmaceuticals
Information provided by:	National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:	NCT00093951

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease	Drug: SGS742	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Memory

Drug Information available for: (3-aminopropyl)(n-butyl)phosphinic acid

U.S. FDA Resources

Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment:	280
Study Start Date:	April 2004
Estimated Study Completion Date:	December 2004

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

Ages Eligible for Study:	55 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00093951

Show 59 Study Locations

Sponsors and Collaborators

Saegis Pharmaceuticals

More Information

Publications:

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.

Study ID Numbers:	IA0061
Study First Received:	October 7, 2004
Last Updated:	February 20, 2009
ClinicalTrials.gov Identifier:	NCT00093951 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Institute on Aging (NIA):

Alzheimer disease
memory
cognition
GABA(B)receptor antagonist

Study placed in the following topic categories:

Neurotransmitter Agents
Delirium, Dementia, Amnestic, Cognitive Disorders
(3-aminopropyl)(n-butyl)phosphinic acid
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Brain Diseases
Dementia
Neuroprotective Agents
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
(3-aminopropyl)(n-butyl)phosphinic acid
Alzheimer Disease
Nervous System Diseases
Physiological Effects of Drugs
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Neuroprotective Agents

Protective Agents
Pharmacologic Actions
GABA Antagonists
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
GABA Agents
Dementia
Tauopathies
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 13, 2009