A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease

Alzheimer's Disease Clinical Trial

Official title:

A Study of the Safety and Efficacy of Multiple Doses of ABT-089 in Subjects With Alzheimer's Disease

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00069849
• Other study ID #: M03-614
• Status: Terminated
• Phase: Phase 2
• First received: October 1, 2003
• Last updated: August 31, 2006
• Start date: July 2003

Study information

• Verified date: August 2006
• 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 compare the safety and efficacy of 2 mg, 4 mg, and 20 mg of ABT-089 BID to placebo in adults with Alzheimer's disease.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 64
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

INCLUSION CRITERIA:

• Current diagnosis of probable Alzheimer's disease.

• ADAS-cog score of at least 12 and MMSE score of 10 to 26.

• Non-smoker

• Must have legally authorized representative and a reliable caregiver. The caregiver and legally authorized representative may be the same person.

• Fluent in English.

EXCLUSION CRITERIA:

• Use of cholinesterase inhibitors or any other drugs to treat Alzheimer's disease in the last 6 weeks.

• Has clinically significant or uncontrolled medical condition other than Alzheimer's disease.

• Nursing home resident.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ABT-089

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	MMSE