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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02573740

Enrollment

Registered

2015-10-12

Start date

2015-12-31

Completion date

2016-06-30

Last updated

2021-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease, Mild Cognitive Impairment

Keywords

Mild Cognitive Impairment, Alzheimer's Disease

Brief summary

This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose study of ABT-957 in participants with mild Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI) due to AD.

Interventions

DRUGABT-957

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Percentage of participants reporting treatment-emergent adverse events	For approximately 84 days
Level of spectrin breakdown product-145 (SBDP-145)	84 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026