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

Purpose

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

Condition	Intervention	Phase
Alzheimer's Disease	Drug: ABT-089 Drug: placebo	Phase II

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease Memory

U.S. FDA Resources

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

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

Further study details as provided by Abbott:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	400
Study Start Date:	November 2007
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental	Drug: ABT-089 5 mg - capsules once daily for 12 weeks
B: Experimental	Drug: ABT-089 10 mg - capsules once daily for 12 weeks
C: Experimental	Drug: ABT-089 15 mg - capsules once daily for 12 weeks
D: Experimental	Drug: ABT-089 20 mg - capsules once daily for 12 weeks
E: Experimental	Drug: ABT-089 30 mg - capsules once daily for 12 weeks
F: Experimental	Drug: ABT-089 35 mg - capsules once daily for 12 weeks
G: Placebo Comparator	Drug: placebo placebo - capsules once daily for 12 weeks

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00555204

Contacts


Contact: Betty Prine	847-937-6928	betty.prine@abbott.com

Sponsors and Collaborators

Abbott

Investigators


Study Director:	Robert A Lenz, MD, PhD	Abbott

More Information

Responsible Party:	Abbott ( Robert Lenz, MD, PhD, Medical Director )
Study ID Numbers:	M06-876
First Received:	November 7, 2007
Last Updated:	June 18, 2008
ClinicalTrials.gov Identifier:	NCT00555204
Health Authority:	United States: Food and Drug Administration