A Study of the Safety and Efficacy of Multiple Doses of A... | NCT00069849

Studies
A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease

NCT00069849

Sponsor

Abbott

Status

Terminated

Last Update Posted

Sep 4, 2006Estimated

Enrollment

Phase

Phase 2

Conditions

Alzheimer's Disease

Interventions

ABT-089

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

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2006

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 1, 2003

First Submission Date that Met QC Criteria

Oct 1, 2003

First Posted Date

Oct 2, 2003Estimated

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

Aug 31, 2006

Last Update Posted Date

Sep 4, 2006Estimated

Description Module

Brief Summary

The purpose of this study is to compare the safety and efficacy of 2 mg, 4 mg, and 20 mg of ABT-089 BID to placebo in adults with Alzheimer's disease.

Detailed Description

Not provided

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
ABT-089	Drug

Measure	Description	Time Frame
MMSE

Eligibility Module

Eligibility Criteria

INCLUSION CRITERIA:

Current diagnosis of probable Alzheimer's disease.
ADAS-cog score of at least 12 and MMSE score of 10 to 26.
Non-smoker
Must have legally authorized representative and a reliable caregiver. The caregiver and legally authorized representative may be the same person.
Fluent in English.

EXCLUSION CRITERIA:

Use of cholinesterase inhibitors or any other drugs to treat Alzheimer's disease in the last 6 weeks.
Has clinically significant or uncontrolled medical condition other than Alzheimer's disease.
Nursing home resident.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Katherine A Tracy, M.D.	Abbott	Study Director

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

Facility	Status	City	State	ZIP	Country	Contacts
		Fresno	California		United States