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 Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: ABT-957
* Other: Placebo for ABT-957


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ABT-957<br>ABT-957 administered twice-daily for 7 days | Drug: ABT-957<br>* ABT-957 administered twice-daily for 7 days<br>|
| Placebo Comparator: Placebo<br>Placebo administered twice-daily for 7 days | Other: Placebo for ABT-957<br>* Placebo for ABT-957 administered twice-daily for 7 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic evaluation of the two ABT-957 diastereomers | maximum observed plasma concentration (Cmax), time to Cmax (peak time, Tmax), plasma concentration at the end of the dosing interval (Ctrough), the area under the plasma concentration-time curve (AUC) during each dosing interval (AUC0-12 and AUC12-24) | Day 7 | 
| Number of subjects with adverse events | Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study | Routinely for the duration of the study, about 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's Disease