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

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

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

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: ABT-089; Drug: ABT-089; Drug: ABT-089; Drug: ABT-089; Drug: ABT-089; Drug: ABT-089; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 337
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
    • Sun City, Arizona, United States, 85351
  • California
    • Fresno, California, United States, 93720
    • San Diego, California, United States, 92108
    • Santa Ana, California, United States, 92705
    • Santa Monica, California, United States, 90404
  • Connecticut
    • Hamden, Connecticut, United States, 06518
    • New Haven, Connecticut, United States, 06510
  • Florida
    • Brooksville, Florida, United States, 34613
    • Delray Beach, Florida, United States, 33445
    • Fort Myers, Florida, United States, 33901
    • Hallendale, Florida, United States, 33009
    • Hialeah, Florida, United States, 33016
    • Largo, Florida, United States, 33770
    • Miami, Florida, United States, 33180
    • Palm Beach Gardens, Florida, United States, 33418
    • Sunrise, Florida, United States, 33351
    • Tampa, Florida, United States, 33613
    • West Palm Beach, Florida, United States, 33407
    • West Palm Beach, Florida, United States, 33409
  • Indiana
    • Indianapolis, Indiana, United States, 46260
  • Kentucky
    • Paducah, Kentucky, United States, 42003
  • Massachusetts
    • Pittsfield, Massachusetts, United States, 01201
  • Michigan
    • Grand Rapids, Michigan, United States, 49503
  • Missouri
    • St Louis, Missouri, United States, 63141
  • New Jersey
    • Long Branch, New Jersey, United States, 07740
    • Nutley, New Jersey, United States, 07110
    • Princeton, New Jersey, United States, 08540
    • Ridgewood, New Jersey, United States, 07450
  • New York
    • Albany, New York, United States, 12208
    • Bronx, New York, United States, 10454
    • New York, New York, United States, 10021
    • Staten Island, New York, United States, 10312
  • North Carolina
    • Hickory, North Carolina, United States, 28601
    • Winston-Salem, North Carolina, United States, 27104
  • Ohio
    • Centerville, Ohio, United States, 45459
    • Cleveland, Ohio, United States, 44106
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
    • Norristown, Pennsylvania, United States, 19401
  • Texas
    • San Antonio, Texas, United States, 78229
    • Wichita Falls, Texas, United States, 76309
  • Vermont
    • Bennington, Vermont, United States, 05201

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: E	Drug: ABT-089; 10 mg - capsules once daily for 12 weeks; Drug: ABT-089; 5 mg - capsules once daily for 12 weeks; Drug: ABT-089; 15 mg - capsules once daily for 12 weeks; Drug: ABT-089; 20 mg - capsules once daily for 12 weeks; Drug: ABT-089; 30 mg - capsules once daily for 12 weeks; Drug: ABT-089; 35 mg - capsules once daily for 12 weeks
Experimental: A	Drug: ABT-089; 10 mg - capsules once daily for 12 weeks; Drug: ABT-089; 5 mg - capsules once daily for 12 weeks; Drug: ABT-089; 15 mg - capsules once daily for 12 weeks; Drug: ABT-089; 20 mg - capsules once daily for 12 weeks; Drug: ABT-089; 30 mg - capsules once daily for 12 weeks; Drug: ABT-089; 35 mg - capsules once daily for 12 weeks
Experimental: B	Drug: ABT-089; 10 mg - capsules once daily for 12 weeks; Drug: ABT-089; 5 mg - capsules once daily for 12 weeks; Drug: ABT-089; 15 mg - capsules once daily for 12 weeks; Drug: ABT-089; 20 mg - capsules once daily for 12 weeks; Drug: ABT-089; 30 mg - capsules once daily for 12 weeks; Drug: ABT-089; 35 mg - capsules once daily for 12 weeks
Experimental: C	Drug: ABT-089; 10 mg - capsules once daily for 12 weeks; Drug: ABT-089; 5 mg - capsules once daily for 12 weeks; Drug: ABT-089; 15 mg - capsules once daily for 12 weeks; Drug: ABT-089; 20 mg - capsules once daily for 12 weeks; Drug: ABT-089; 30 mg - capsules once daily for 12 weeks; Drug: ABT-089; 35 mg - capsules once daily for 12 weeks
Experimental: D	Drug: ABT-089; 10 mg - capsules once daily for 12 weeks; Drug: ABT-089; 5 mg - capsules once daily for 12 weeks; Drug: ABT-089; 15 mg - capsules once daily for 12 weeks; Drug: ABT-089; 20 mg - capsules once daily for 12 weeks; Drug: ABT-089; 30 mg - capsules once daily for 12 weeks; Drug: ABT-089; 35 mg - capsules once daily for 12 weeks
Experimental: F	Drug: ABT-089; 10 mg - capsules once daily for 12 weeks; Drug: ABT-089; 5 mg - capsules once daily for 12 weeks; Drug: ABT-089; 15 mg - capsules once daily for 12 weeks; Drug: ABT-089; 20 mg - capsules once daily for 12 weeks; Drug: ABT-089; 30 mg - capsules once daily for 12 weeks; Drug: ABT-089; 35 mg - capsules once daily for 12 weeks
Placebo Comparator: G	Drug: placebo; placebo - capsules once daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety and Tolerability	Baseline to Final Evaluation

Secondary Outcome Measures

Outcome Measure	Time Frame
Pharmacokinetics (how the body handles the study drug)	Baseline to Final Evaluation
Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory)	Baseline to Final Evaluation

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Robert Lenz, MD, PhD, Abbott

Publications and helpful links

General Publications

• Lenz RA, Pritchett YL, Berry SM, Llano DA, Han S, Berry DA, Sadowsky CH, Abi-Saab WM, Saltarelli MD. Adaptive, dose-finding phase 2 trial evaluating the safety and efficacy of ABT-089 in mild to moderate Alzheimer disease. Alzheimer Dis Assoc Disord. 2015 Jul-Sep;29(3):192-9. doi: 10.1097/WAD.0000000000000093.

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: November 7, 2007
• First Submitted That Met QC Criteria: November 7, 2007
• First Posted (Estimate): November 8, 2007

Study Record Updates

• Last Update Posted (Estimate): August 23, 2011
• Last Update Submitted That Met QC Criteria: August 19, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: mild to moderate Alzheimer's disease, memory, cognition, dementia
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: M06-876