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

CoMentis has indicated that access to an investigational treatment associated with this study is available outside the clinical trial.

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

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

Keywords provided by CoMentis:

Alzheimer
Probable Alzheimer disease

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-(2,4-dimethoxybenzylidene)anabaseine
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on February 09, 2012