NCT00069849

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
1 country

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2003

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2003

Completed
Last Updated

September 4, 2006

Status Verified

August 1, 2006

First QC Date

October 1, 2003

Last Update Submit

August 31, 2006

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • MMSE

Interventions

ABT-089DRUG

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Unknown Facility

Fresno, California, United States

Location

Unknown Facility

San Diego, California, United States

Location

Unknown Facility

Orlando, Florida, United States

Location

Unknown Facility

West Palm Beach, Florida, United States

Location

Unknown Facility

Florence, Kentucky, United States

Location

Unknown Facility

Portland, Oregon, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Bennington, Vermont, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

pozanicline

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Katherine A Tracy, M.D.

    Abbott

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

October 1, 2003

First Posted

October 2, 2003

Study Start

July 1, 2003

Last Updated

September 4, 2006

Record last verified: 2006-08

Locations

US(8)