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TerminatedPhase 1

Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment

A Study to Evaluate the Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of Multiple Doses of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment Due to Alzheimer's Disease

Lead sponsor

AbbVie

Asset

ABT-957

Listed sites

9

Recruiting sites

-

Enrollment

8

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criterion

•MCI due to AD

Primary endpoints

•Treatment-emergent adverse events•Level of spectrin breakdown product-145 (SBDP-145)

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 IDM13-730
NCT IDNCT02573740

Timeline

Milestones

Study first posted2015-10-12estimated
Study start2015-12 (month precision)
Primary completion2016-06actual (month precision)
Study completion2016-06actual (month precision)
Last update posted2021-07-06actual

Assets

Drug assets

ABT-957

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years
Maximum age85 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Female participants must have negative results for pregnancy test performed on a serum sample obtained at Screening
•Body Mass Index is 18.0 to 35.0 at Screening
•Meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable Alzheimer's disease (AD).
•Meets the NIA-AA core clinical criteria for Mild Cognitive Impairment due to AD

Exclusion criteria

•Use of any strong inhibitors of drug metabolizing enzymes within 30 days prior to study drug administration
•Consumption of alcohol within 24 hours prior to study drug administration
•Positive screen for non-prescribed drugs of abuse or alcohol
•The participant has clinically significant abnormal laboratory values at Screening as determined by the investigator
•History of a drug or alcohol abuse within 6 months prior to study drug administration
•Current diagnosis of major depression or other major psychiatric disorder

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.

Coverage by outcome category

Safety / tolerability / PK
1
Other (unclassified)
1

Safety / tolerability / PK

1 endpoint
Primary/protocol endpoint

Percentage of participants reporting treatment-emergent adverse events

Time frame:For approximately 84 days

threshold achievement, event

Other (unclassified)

1 endpoint
Primary/protocol endpoint/low confidence

Level of spectrin breakdown product-145 (SBDP-145)

Time frame:84 days

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

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.