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TerminatedPhase 1

Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

A Multiple-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Lead sponsor

AbbVie

Asset

ABT-957

Listed sites

4

Recruiting sites

-

Enrollment

19

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 16-26•AD symptomatic therapy: stable

Primary endpoints

•Pharmacokinetic evaluation of the two ABT-957 diastereomers•Adverse events

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 IDM13-334
NCT IDNCT02220738

Timeline

Milestones

Study first posted2014-08-20estimated
Study start2014-09 (month precision)
Primary completion2016-03actual (month precision)
Study completion2016-03actual (month precision)
Last update posted2021-07-06actual

Assets

Drug assets

ABT-957

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

•Meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable Alzheimer's disease (AD);
•Has a Mini-Mental State Examination total score of 16 to 26;
•Has a Modified Hachinski Ischemia Scale score of ≤ 4;
•Is taking a stable dose of donepezil, galantamine or rivastigmine for at least 30 days;
•Has had a computerized tomography or magnetic resonance imaging. The scan must not show evidence for an alternative etiology for dementia;
•With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, is in general good health

Exclusion criteria

•Positive screen for drugs of abuse, alcohol or cotinine;
•Females must not have positive results for pregnancy;
•Focal neurological signs on examination;
•Has a clinically significant abnormal value, in serum chemistry, hematology or urinalysis;
•History of any significant neurologic disease other than AD;
•History of head trauma, motor vehicle accident, concussion.

Endpoints (2)

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.

Safety / tolerability / PK

2 endpoints
Primary/protocol endpoint

Pharmacokinetic evaluation of the two ABT-957 diastereomers

Time frame:Day 7

time to event, event

Primary/protocol endpoint

Number of subjects with adverse events

Time frame:Routinely for the duration of the study, about 7 months

event count, event

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

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.