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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02573740
• Other study ID #: M13-730
• Status: Terminated
• Phase: Phase 1
• Start date: December 2015
• Est. completion date: June 2016

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Drug:
• ABT-957

Other:
• Placebo

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 143182	Cincinnati	Ohio
United States	Site Reference ID/Investigator# 143180	Cypress	California
United States	Site Reference ID/Investigator# 149481	Dallas	Texas
United States	Site Reference ID/Investigator# 143181	Marlton	New Jersey
United States	Site Reference ID/Investigator# 143254	Orem	Utah
United States	Site Reference ID/Investigator# 143178	Orlando	Florida
United States	Site Reference ID/Investigator# 143179	Salt Lake City	Utah
United States	Site Reference ID/Investigator# 143177	Spokane	Washington
United States	Site Reference ID/Investigator# 149484	The Villages	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lon HK, Mendonca N, Goss S, Othman AA, Locke C, Jin Z, Rendenbach-Mueller B. Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Alicapistat, a Selective Inhibitor of Human Calpains 1 and 2 for the Treatment of Alzheimer Disease: An Overview o — View Citation

Outcome

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