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

Tracking Information
First Received Date ^ICMJE	October 7, 2004
Last Updated Date	February 20, 2009
Start Date ^ICMJE	April 2004
Current Primary Outcome Measures ^ICMJE
Original Primary Outcome Measures ^ICMJE
Change History	Complete list of historical versions of study NCT00093951 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	SGS742 in Patients With Mild to Moderate Alzheimer's Disease (AD)
Official Title ^ICMJE	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
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.
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Double-Blind, Placebo Control, Safety/Efficacy Study
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Drug: SGS742
Study Arms / Comparison Groups
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.
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	280
Completion Date	December 2004
Primary Completion Date
Eligibility Criteria ^ICMJE	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)
Gender	Both
Ages	55 Years to 90 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States
Expanded Access Status

Administrative Information
NCT ID ^ICMJE	NCT00093951
Responsible Party
Study ID Numbers ^ICMJE	IA0061
Study Sponsor ^ICMJE	Saegis Pharmaceuticals
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	National Institute on Aging (NIA)
Verification Date	February 2009
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP