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.
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
Cincinnati, Ohio
Principal Investigator: Site Reference ID/Investigator# 143182, MD
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Cypress, California
Principal Investigator: Site Reference ID/Investigator# 143180, MD
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Marlton, New Jersey 08053
Principal Investigator: Site Reference ID/Investigator# 143181, MD, DO
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Orem, Utah
Principal Investigator: Site Reference ID/Investigator# 143254, DO
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Orlando, Florida 32804
Principal Investigator: Site Reference ID/Investigator# 143178, MD
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Salt Lake City, Utah
Principal Investigator: Site Reference ID/Investigator# 143179, MD
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Spokane, Washington
Principal Investigator: Site Reference ID/Investigator# 143177, MD
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