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

Abbott

Status and phase: Terminated; Phase 2

Conditions: Alzheimer's Disease

Treatments: Drug: placebo; Drug: ABT-089

Study type: Interventional

Funder types: Industry

Identifiers

NCT00555204

M06-876

Details and patient eligibility

About

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

Enrollment: 337 patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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337 participants in 7 patient groups, including a placebo group

A

Experimental group

Treatment:

Drug: ABT-089

B

Experimental group

Treatment:

Drug: ABT-089

C

Experimental group

Treatment:

Drug: ABT-089

D

Experimental group

Treatment:

Drug: ABT-089

E

Experimental group

Treatment:

Drug: ABT-089

F

Experimental group

Treatment:

Drug: ABT-089

G

Placebo Comparator group

Treatment:

Drug: placebo