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

July 2, 2021 updated by: AbbVie

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Cypress, California, United States, 90630
        • Site Reference ID/Investigator# 143180
    • Florida
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 143178
      • The Villages, Florida, United States, 32162
        • Site Reference ID/Investigator# 149484
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Site Reference ID/Investigator# 143181
    • Ohio
      • Cincinnati, Ohio, United States, 45255
        • Site Reference ID/Investigator# 143182
    • Texas
      • Dallas, Texas, United States, 75231
        • Site Reference ID/Investigator# 149481
    • Utah
      • Orem, Utah, United States, 84058
        • Site Reference ID/Investigator# 143254
      • Salt Lake City, Utah, United States, 84107
        • Site Reference ID/Investigator# 143179
    • Washington
      • Spokane, Washington, United States, 99202
        • Site Reference ID/Investigator# 143177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ABT-957
ABT-957 given twice a day for 84 days
Drug: ABT-957
Placebo Comparator: Placebo
Placebo given twice a day for 84 days
Other: Placebo

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: Nuno Mendonca, MD, AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

October 8, 2015

First Submitted That Met QC Criteria

October 8, 2015

First Posted (Estimate)

October 12, 2015

Study Record Updates

Last Update Posted (Actual)

July 6, 2021

Last Update Submitted That Met QC Criteria

July 2, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M13-730

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Mild Cognitive Impairment

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Senegal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe