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

• Status: Terminated
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AbbVie

Criteria

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