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

Sponsor:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00555204

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

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Memory

U.S. FDA Resources

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 ]

Enrollment:	337
Study Start Date:	November 2007
Estimated Primary Completion Date:	June 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

Ages Eligible for Study:	55 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Show 42 Study Locations

Sponsors and Collaborators

Abbott

Investigators

Study Director:

Daniel Llano, MD, PhD

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Daniel Llano, MD, PhD, Associate Medical Director )
Study ID Numbers:	M06-876
Study First Received:	November 7, 2007
Last Updated:	June 10, 2009
ClinicalTrials.gov Identifier:	NCT00555204 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Abbott:

mild to moderate Alzheimer's disease, memory, cognition, dementia

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Central Nervous System Diseases
Enzyme Inhibitors
Cholinergic Agents

Brain Diseases
Neurodegenerative Diseases
Pharmacologic Actions
Cholinesterase Inhibitors
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Dementia
Tauopathies

ClinicalTrials.gov processed this record on November 27, 2009