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

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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
9
sites
Orlando, Florida 32804
Principal Investigator: Site Reference ID/Investigator# 143178, MD
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Orlando, FL
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Cincinnati, Ohio
Principal Investigator: Site Reference ID/Investigator# 143182, MD
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Cincinnati, OH
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Cypress, California
Principal Investigator: Site Reference ID/Investigator# 143180, MD
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Cypress, CA
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Dallas, TX
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Marlton, New Jersey 08053
Principal Investigator: Site Reference ID/Investigator# 143181, MD, DO
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Marlton, NJ
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Orem, Utah
Principal Investigator: Site Reference ID/Investigator# 143254, DO
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Orem, UT
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Salt Lake City, Utah
Principal Investigator: Site Reference ID/Investigator# 143179, MD
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Salt Lake City, UT
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Spokane, Washington
Principal Investigator: Site Reference ID/Investigator# 143177, MD
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Spokane, WA
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The Villages, FL
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