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 |
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.
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
Orlando, Florida 32804
Principal Investigator: Site Reference ID/Investigator# 129435, MD
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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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Salt Lake City, Utah
Principal Investigator: Site Reference ID/Investigator# 144825, MD
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