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
Conditions:	Alzheimer Disease, Cognitive Studies
Therapuetic Areas:	Neurology, Psychiatry / Psychology
Healthy:	No
Age Range:	55 - 85
Updated:	7/2/2016
Start Date:	December 2015
End Date:	June 2016

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.

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

We found this trial at

sites

Clinical Trial Facility in Spokane Washington

Spokane, Washington

Principal Investigator: Site Reference ID/Investigator# 143177, MD

from

Spokane, WA