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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2016-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT02220738

Alzheimer's Disease

TERMINATED PHASE1

A Study of the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Anti-Abeta (MABT5102A) in Patients With Alzheimer's Disease

NCT00736775

Alzheimer's Disease

COMPLETED PHASE1

Study of the Effect of SR57667B in Patients With Alzheimer's Disease

NCT00285025

Alzheimer Disease

COMPLETED PHASE2

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

NCT00555204

Alzheimer's Disease

TERMINATED PHASE2

This is a Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease

NCT01676935

Alzheimer's Disease

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease Mild Cognitive Impairment

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ABT-957

ABT-957 given twice a day for 84 days

Group Type EXPERIMENTAL

ABT-957

Intervention Type DRUG

Placebo

Placebo given twice a day for 84 days

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ABT-957

Intervention Type DRUG

Placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No