TerminatedPhase 2

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

A Randomized, Double-Blind, Placebo-Controlled Study Using a Bayesian Adaptive Design to Evaluate the Efficacy and Safety of ABT-089 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Lead sponsor

Abbott

Asset

ABT-089

Listed sites

Recruiting sites

Enrollment

337

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 12-26•Study partner/caregiver required•AD symptomatic therapy: stable

Primary endpoint

•Safety and Tolerability

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDM06-876

NCT IDNCT00555204

Timeline

Milestones

Study start2007-11 (month precision)

Study first posted2007-11-08estimated

Primary completion2009-06actual (month precision)

Last update posted2011-08-23estimated

Assets

Drug assets

ABT-089

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age90 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Memory

1 endpoint

Secondary/protocol endpoint

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

Time frame:Baseline to Final Evaluation

descriptive

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Safety and Tolerability

Time frame:Baseline to Final Evaluation

descriptive

Secondary/protocol endpoint

Pharmacokinetics (how the body handles the study drug)

Time frame:Baseline to Final Evaluation

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.
PMID25973909via DERIVED

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.