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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Abbott
ClinicalTrials.gov Identifier:
NCT00555204
First received: November 7, 2007
Last updated: August 19, 2011
Last verified: August 2011

November 7, 2007
August 19, 2011
November 2007
June 2009   (final data collection date for primary outcome measure)
Safety and Tolerability [ Time Frame: Baseline to Final Evaluation ] [ Designated as safety issue: Yes ]
Safety and Tolerability [ Time Frame: Baseline to Final Evaluation ]
Complete list of historical versions of study NCT00555204 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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
  • Drug: placebo
    placebo - capsules once daily for 12 weeks
  • Experimental: A
    Intervention: Drug: ABT-089
  • Experimental: B
    Intervention: Drug: ABT-089
  • Experimental: C
    Intervention: Drug: ABT-089
  • Experimental: D
    Intervention: Drug: ABT-089
  • Experimental: E
    Intervention: Drug: ABT-089
  • Experimental: F
    Intervention: Drug: ABT-089
  • Placebo Comparator: G
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
337
Not Provided
June 2009   (final data collection date for primary outcome measure)

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
Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00555204
M06-876
Yes
Abbott
Abbott
Not Provided
Study Director: Robert Lenz, MD, PhD Abbott
Abbott
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP