Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors



Status:Recruiting
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:55 - 90
Updated:4/21/2016
Start Date:September 2014
End Date:June 2016
Contact:Ramanuj Achari, PhD
Email:ramanuj.achari@abbvie.com
Phone:847-935-2606

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A Multiple-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple
doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.


Inclusion Criteria:

- Meets the National Institute of Neurological and Communicative Disorders and
Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable
Alzheimer's disease (AD);

- Has a Mini-Mental State Examination total score of 16 to 26;

- Has a Modified Hachinski Ischemia Scale score of ≤ 4;

- Is taking a stable dose of donepezil, galantamine or rivastigmine for at least 30
days;

- Has had a computerized tomography or magnetic resonance imaging. The scan must not
show evidence for an alternative etiology for dementia;

- With the exception of a diagnosis of mild-to-moderate AD and the presence of stable
medical conditions, is in general good health.

Exclusion Criteria:

- Positive screen for drugs of abuse, alcohol or cotinine;

- Females must not have positive results for pregnancy;

- Focal neurological signs on examination;

- Has a clinically significant abnormal value, in serum chemistry, hematology or
urinalysis;

- History of any significant neurologic disease other than AD;

- History of head trauma, motor vehicle accident, concussion.
We found this trial at
4
sites
Glendale, California 91206
Principal Investigator: Site Reference ID/Investigator# 129545, MD
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New York, New York 10032
Principal Investigator: Site Reference ID/Investigator# 129641, MD
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New York, NY
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Orlando, Florida 32804
Principal Investigator: Site Reference ID/Investigator# 129435, MD
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Orlando, FL
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Salt Lake City, Utah
Principal Investigator: Site Reference ID/Investigator# 144825, MD
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Salt Lake City, UT
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