Back to resultsGTS21-201 for Alzheimer Disease:GTS-21 Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
DMXB-A
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer, Probable Alzheimer disease
Eligibility Criteria
Inclusion Criteria:
- probable Alzheimer
Exclusion Criteria:
- others
Sites / Locations
- Clinical Dept.
Outcomes
Primary Outcome Measures
CDR
Secondary Outcome Measures
ADAS-cog
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00414622
Brief Title
GTS21-201 for Alzheimer Disease:GTS-21 Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2006
Overall Recruitment Status
Completed
Study Start Date
November 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CoMentis
4. Oversight
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer, Probable Alzheimer disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
DMXB-A
Primary Outcome Measure Information:
Title
CDR
Secondary Outcome Measure Information:
Title
ADAS-cog
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
probable Alzheimer
Exclusion Criteria:
others
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Hsu, MD
Organizational Affiliation
CoMentis
Official's Role
Study Director
Facility Information:
Facility Name
Clinical Dept.
City
280 South San Francisco
State/Province
California
Country
United States
12. IPD Sharing Statement
Learn more about this trial
GTS21-201 for Alzheimer Disease:GTS-21 Administered Daily for 28 Days to Participants With Probable Alzheimer's Disease
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