NCT00414622

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for phase_2 alzheimer-disease

Timeline
Completed

Started Nov 2006

Shorter than P25 for phase_2 alzheimer-disease

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 21, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 19, 2007

Status Verified

December 1, 2006

First QC Date

December 19, 2006

Last Update Submit

April 18, 2007

Conditions

Alzheimer Disease

Keywords

AlzheimerProbable Alzheimer disease

Outcome Measures

Primary Outcomes (1)

  • CDR

Secondary Outcomes (1)

  • ADAS-cog

Interventions

DMXB-ADRUG

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • probable Alzheimer

You may not qualify if:

  • others

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Dept.

280 South San Francisco, California, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

3-(2,4-dimethoxybenzylidene)anabaseine

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Henry Hsu, MD

    CoMentis

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Expanded Access
Yes

Study Record Dates

First Submitted

December 19, 2006

First Posted

December 21, 2006

Study Start

November 1, 2006

Study Completion

April 1, 2007

Last Updated

April 19, 2007

Record last verified: 2006-12

Locations

US(1)