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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00555204
• Other study ID #: M06-876
• Status: Terminated
• Phase: Phase 2
• First received: November 7, 2007
• Last updated: August 19, 2011
• Start date: November 2007

Study information

• Verified date: August 2011
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 337
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years to 90 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ABT-089
10 mg - capsules once daily for 12 weeks
• ABT-089
5 mg - capsules once daily for 12 weeks
• ABT-089
15 mg - capsules once daily for 12 weeks
• ABT-089
20 mg - capsules once daily for 12 weeks
• ABT-089
30 mg - capsules once daily for 12 weeks
• ABT-089
35 mg - capsules once daily for 12 weeks
• placebo
placebo - capsules once daily for 12 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability		Baseline to Final Evaluation	Yes
Secondary	Pharmacokinetics (how the body handles the study drug)		Baseline to Final Evaluation	No
Secondary	Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory)		Baseline to Final Evaluation	No