GTS21-201 for Alzheimer Disease:GTS-21 Administered Daily... | NCT00414622

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

NCT00414622

Sponsor

CoMentis

Status

Completed

Last Update Posted

Apr 19, 2007Estimated

Enrollment

Phase

Phase 2

Conditions

Alzheimer Disease

Interventions

DMXB-A

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2006

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Yes

Start Date

Nov 2006

Primary Completion Date

Not provided

Completion Date

Apr 2007Actual

First Submitted Date

Dec 19, 2006

First Submission Date that Met QC Criteria

Dec 20, 2006

First Posted Date

Dec 21, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 18, 2007

Last Update Posted Date

Apr 19, 2007Estimated

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
DMXB-A	Drug

Measure	Description	Time Frame
CDR

Measure	Description	Time Frame
ADAS-cog

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

probable Alzheimer

Exclusion Criteria:

others

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Henry Hsu, MD	CoMentis	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Clinical Dept.		280 South San Francisco	California		United States

Type	Date	Date Unknown
Release	Aug 16, 2010
Reset	Sep 9, 2010

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Aug 16, 2010			Sep 9, 2010

Condition Browse Module

MeSH Terms

ID	Term
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C088936	3-(2,4-dimethoxybenzylidene)anabaseine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided