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

This study has been terminated.
Information provided by (Responsible Party):
Abbott Identifier:
First received: November 7, 2007
Last updated: August 19, 2011
Last verified: August 2011
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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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:

Further study details as provided by Abbott:

Primary Outcome Measures:
  • Safety and Tolerability [ Time Frame: Baseline to Final Evaluation ]

Secondary Outcome Measures:
  • Pharmacokinetics (how the body handles the study drug) [ Time Frame: Baseline to Final Evaluation ]
  • Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory) [ Time Frame: Baseline to Final Evaluation ]

Enrollment: 337
Study Start Date: November 2007
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: ABT-089
5 mg - capsules once daily for 12 weeks
Experimental: B Drug: ABT-089
10 mg - capsules once daily for 12 weeks
Experimental: C Drug: ABT-089
15 mg - capsules once daily for 12 weeks
Experimental: D Drug: ABT-089
20 mg - capsules once daily for 12 weeks
Experimental: E Drug: ABT-089
30 mg - capsules once daily for 12 weeks
Experimental: F Drug: ABT-089
35 mg - capsules once daily for 12 weeks
Placebo Comparator: G Drug: placebo
placebo - capsules once daily for 12 weeks


Ages Eligible for Study:   55 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00555204

  Show 42 Study Locations
Sponsors and Collaborators
Study Director: Robert Lenz, MD, PhD Abbott
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Abbott Identifier: NCT00555204     History of Changes
Other Study ID Numbers: M06-876
Study First Received: November 7, 2007
Last Updated: August 19, 2011

Keywords provided by Abbott:
mild to moderate Alzheimer's disease, memory, cognition, dementia

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs processed this record on August 18, 2017