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

Phase 1

Terminated

• Conditions: Alzheimer's Disease; Mild Cognitive Impairment
• Interventions: Drug: ABT-957; Other: Placebo

• Registration Number: NCT02573740
• Lead Sponsor: AbbVie

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-08
• Study First Submitted QC: 2015-10-08
• Study First Posted: 2015-10-12
• Study Start: 2015-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-02
• Last Update Posted: 2021-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ABT-957	ABT-957	ABT-957 given twice a day for 84 days
Placebo	Placebo	Placebo given twice a day for 84 days

Primary Outcome Measures

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

Trial Locations

Locations (9)

Site Reference ID/Investigator# 149481; 🇺🇸 Dallas, Texas, United States

Site Reference ID/Investigator# 143180; 🇺🇸 Cypress, California, United States

Site Reference ID/Investigator# 143178; 🇺🇸 Orlando, Florida, United States

Site Reference ID/Investigator# 143181; 🇺🇸 Marlton, New Jersey, United States

Site Reference ID/Investigator# 149484; 🇺🇸 The Villages, Florida, United States

Site Reference ID/Investigator# 143182; 🇺🇸 Cincinnati, Ohio, United States

Site Reference ID/Investigator# 143179; 🇺🇸 Salt Lake City, Utah, United States

Site Reference ID/Investigator# 143254; 🇺🇸 Orem, Utah, United States

Site Reference ID/Investigator# 143177; 🇺🇸 Spokane, Washington, United States