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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:
ClinicalTrials.gov Identifier:
NCT00414622
First Posted: December 21, 2006
Last Update Posted: April 19, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
CoMentis
  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
Intervention Model: Parallel Assignment
Masking: Double
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:


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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • probable Alzheimer

Exclusion Criteria:

  • others
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
ClinicalTrials.gov Identifier: NCT00414622     History of Changes
Other Study ID Numbers: GTS21-201
First Submitted: December 19, 2006
First Posted: December 21, 2006
Last Update Posted: April 19, 2007
Last Verified: December 2006

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
Neurocognitive Disorders
Mental Disorders
3-(2,4-dimethoxybenzylidene)anabaseine
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs


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