Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease - Tabular View

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Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease

This study is currently recruiting participants.
Information provided by Abbott

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease

Official Title ^†

A Randomized, Double-Blind, Placebo-Controlled Study Using a Bayesian Adaptive Design to Evaluate the Efficacy and Safety of ABT-089 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Brief Summary

The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for Alzheimer's disease.

Detailed Description

Study Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary Outcome Measure ^†

Safety and Tolerability [ Time Frame: Baseline to Final Evaluation ] [ Designated as safety issue: Yes ]

Secondary Outcome Measure ^†

Pharmacokinetics (how the body handles the study drug) [ Time Frame: Baseline to Final Evaluation ] [ Designated as safety issue: No ]
Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory) [ Time Frame: Baseline to Final Evaluation ] [ Designated as safety issue: No ]

Condition ^†

Alzheimer's Disease

Intervention ^†

Drug: ABT-089
Drug: placebo

MEDLINE PMIDs

Links

Recruitment Information Fields

Recruitment Status ^†

Recruiting

Enrollment ^†

400

Start Date ^†

November 2007

Completion Date

Eligibility Criteria ^†

Inclusion Criteria:

Patient has mild to moderate Alzheimer's disease
Patient has been receiving a stable dose of an acetylcholinesterase inhibitor
Patient has a MMSE score between 12 and 26
Patient has a MHIS score of less than or equal to 4
Females must be postmenopausal for at least two years or surgically sterile
Patient has an identified, reliable, caregiver who will support him/her to ensure compliance with treatment and will accompany them to each outpatient visit

Exclusion Criteria:

Patient is living in a nursing home
Patient has a history of any significant neurologic disease other than Alzheimer's disease
Patient has any uncontrolled medical illness
Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence

Gender

Both

Ages

55 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^††

Contact: Betty Prine

847-937-6928

betty.prine@abbott.com

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00555204

Organization ID

M06-876

Secondary IDs ^††

Study Sponsor ^†

Abbott

Collaborators ^††

Investigators ^†

Study Director:

Robert A Lenz, MD, PhD

Abbott

Information Provided By

Abbott

Verification Date

August 2008

First Received Date ^†

November 7, 2007

Last Updated Date

August 29, 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.