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

This study has been completed.
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00093951
First received: October 7, 2004
Last updated: December 10, 2009
Last verified: February 2009
History of Changes
  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 2

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

U.S. FDA Resources

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

Estimated Enrollment: 280
Study Start Date: April 2004
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
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:

ClinicalTrials.gov Identifier: NCT00093951     History of Changes
Other Study ID Numbers: IA0061
Study First Received: October 7, 2004
Last Updated: December 10, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute on Aging (NIA):
Alzheimer disease
memory
cognition
GABA(B)receptor antagonist

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
(3-aminopropyl)(n-butyl)phosphinic acid
 Neuroprotective Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
GABA Antagonists
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013