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

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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

0

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Data sourced from clinicaltrials.gov

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