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

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

Trial contacts and locations

42

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