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

AbbVie

Status and phase

Terminated

Phase 1

Conditions

Alzheimer's Disease

Mild Cognitive Impairment

Treatments

Drug: ABT-957

Other: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02573740

M13-730

Details and patient eligibility

About

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.

Enrollment

8 patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

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