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TerminatedNCT00555204Updated Aug 23, 2011

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

A Phase 2 interventional study of ABT-089 and ABT-089 in Alzheimer's Disease, sponsored by Abbott. Terminated at 42 sites in United States. Open to participants aged 55 Years to 90 Years. Per ClinicalTrials.gov, last updated 2011-08-23.

Sponsored by Abbott · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
337
Allocation
Randomized
Ages
55 Years to 90 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Alzheimer's Disease

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Keywords

  • mild to moderate Alzheimer's disease, memory, cognition, dementia
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 337 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Abbott is the lead sponsor of 350 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
337 participants (actual)

Study arms

  • Experimental
    A

    Drug: ABT-089

  • Experimental
    B

    Drug: ABT-089

  • Experimental
    C

    Drug: ABT-089

  • Experimental
    D

    Drug: ABT-089

  • Experimental
    E

    Drug: ABT-089

  • Experimental
    F

    Drug: ABT-089

  • Placebo comparator
    G

    Drug: placebo

Interventions

  • DrugABT-089

    10 mg - capsules once daily for 12 weeks

  • DrugABT-089

    5 mg - capsules once daily for 12 weeks

  • DrugABT-089

    15 mg - capsules once daily for 12 weeks

  • DrugABT-089

    20 mg - capsules once daily for 12 weeks

  • DrugABT-089

    30 mg - capsules once daily for 12 weeks

  • DrugABT-089

    35 mg - capsules once daily for 12 weeks

  • Drugplacebo

    placebo - capsules once daily for 12 weeks

06

What researchers measure

Primary outcomes

  1. Safety and Tolerability

    Time frame: Baseline to Final Evaluation

Secondary outcomes

  1. Pharmacokinetics (how the body handles the study drug)

    Time frame: Baseline to Final Evaluation

  2. Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory)

    Time frame: Baseline to Final Evaluation

07

Study locations

42 sites
  • Phoenix, Arizona 85006, United States
  • Sun City, Arizona 85351, United States
  • Fresno, California 93720, United States
  • San Diego, California 92108, United States
  • Santa Ana, California 92705, United States
  • Santa Monica, California 90404, United States
  • Hamden, Connecticut 06518, United States
  • New Haven, Connecticut 06510, United States
  • Brooksville, Florida 34613, United States
  • Delray Beach, Florida 33445, United States
  • Fort Myers, Florida 33901, United States
  • Hallendale, Florida 33009, United States
  • Hialeah, Florida 33016, United States
  • Largo, Florida 33770, United States
  • Miami, Florida 33180, United States
  • Palm Beach Gardens, Florida 33418, United States
  • Sunrise, Florida 33351, United States
  • Tampa, Florida 33613, United States
  • West Palm Beach, Florida 33407, United States
  • West Palm Beach, Florida 33409, United States
  • Indianapolis, Indiana 46260, United States
  • Paducah, Kentucky 42003, United States
  • Pittsfield, Massachusetts 01201, United States
  • Grand Rapids, Michigan 49503, United States
  • St Louis, Missouri 63141, United States
  • Long Branch, New Jersey 07740, United States
  • Nutley, New Jersey 07110, United States
  • Princeton, New Jersey 08540, United States
  • Ridgewood, New Jersey 07450, United States
  • Albany, New York 12208, United States
  • Bronx, New York 10454, United States
  • New York, New York 10021, United States
  • Staten Island, New York 10312, United States
  • Hickory, North Carolina 28601, United States
  • Winston-Salem, North Carolina 27104, United States
  • Centerville, Ohio 45459, United States
  • Cleveland, Ohio 44106, United States
  • Jenkintown, Pennsylvania 19046, United States
  • Norristown, Pennsylvania 19401, United States
  • San Antonio, Texas 78229, United States
  • Wichita Falls, Texas 76309, United States
  • Bennington, Vermont 05201, United States
08

References and documents

Publications

  • Lenz RA, Pritchett YL, Berry SM, Llano DA, Han S, Berry DA, Sadowsky CH, Abi-Saab WM, Saltarelli MD. Adaptive, dose-finding phase 2 trial evaluating the safety and efficacy of ABT-089 in mild to moderate Alzheimer disease. Alzheimer Dis Assoc Disord. 2015 Jul-Sep;29(3):192-9. doi: 10.1097/WAD.0000000000000093. PubMed 25973909 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 23, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00555204
Lead sponsor
Abbott
Responsible party
Sponsor
First posted
Nov 8, 2007
Start date
Nov 2007
Primary completion
Jun 2009
Last update
Aug 23, 2011

Study contacts

Robert Lenz, MD, PhD
study director · Abbott

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2011. You cannot join it, but the record below documents what was studied.

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