GTS21-201 for Alzheimer Disease:GTS-21 Administered Daily for 28 Days to Participants With Probable Alzheimer’s Disease - Full Text View

Sponsor:	CoMentis
Information provided by:	CoMentis
ClinicalTrials.gov Identifier:	NCT00414622

Purpose

A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days to Participants With Probable Alzheimer’s Disease

Condition	Intervention	Phase
Alzheimer Disease	Drug: DMXB-A	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days to Participants With Probable Alzheimer’s Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Gts 21

U.S. FDA Resources

Further study details as provided by CoMentis:

Primary Outcome Measures:

CDR

Secondary Outcome Measures:

ADAS-cog

Estimated Enrollment:	60
Study Start Date:	November 2006
Study Completion Date:	April 2007

Detailed Description:

A Double Blind, Placebo-Controlled Randomized Study to Compare the Safety and Tolerability of GTS-21 (25 Mg TID, 50 Mg TID, 75 Mg TID and 150 Mg TID) When Administered Daily for 28 Days to Participants With Probable Alzheimer’s Disease

Eligibility

Ages Eligible for Study:	50 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

probable Alzheimer

Exclusion Criteria:

others

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00414622

Locations

United States, California
Clinical Dept.
280 South San Francisco, California, United States

Sponsors and Collaborators

CoMentis

Investigators

Study Director:

Henry Hsu, MD

CoMentis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	GTS21-201
Study First Received:	December 19, 2006
Last Updated:	April 18, 2007
ClinicalTrials.gov Identifier:	NCT00414622 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by CoMentis:

Alzheimer
Probable Alzheimer disease

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on November 09, 2009