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

Study Identifier
M13-334
CT.gov Identifier
NCT02220738
EudraCT Identifier
Not available
EUCTIS ID
Not available
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844-663-3742 or [email protected]

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Study Details

Medical Condition
  • Alzheimer's Disease
    • Study Drug
  • ABT-957
    • Phase
    Phase 1
    Sex
    Female & Male
    Age
    55 - 90 Years
    Inclusion and Exclusion Criteria
    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.

    Protocol Summary

    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.

    Study Locations

    Location
    Status
    Location
    Site Reference ID/Investigator# 129545
    Glendale, California, United States, 91206
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 129435
    Orlando, Florida, United States, 32806
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 129641
    New York, New York, United States, 10019
    Status
    Not applicable
    Location
    Site Reference ID/Investigator# 144825
    Salt Lake City, Utah, United States, 84106
    Status
    Not applicable