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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:
Information provided by:
CoMentis
ClinicalTrials.gov Identifier:
NCT00414622
First received: December 19, 2006
Last updated: April 18, 2007
Last verified: December 2006
  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:


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
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, see Learn About Clinical Studies.

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:
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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 25, 2014