Text Size

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

This study has been completed.
Sponsor:
Information provided by:
CoMentis
ClinicalTrials.gov Identifier:
NCT00414622
First received: December 19, 2006
Last updated: April 18, 2007
Last verified: December 2006
History of Changes
  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 2

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:

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 May 21, 2013