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
- Registration Number
- NCT02220738
- Lead Sponsor
- AbbVie
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABT-957 ABT-957 ABT-957 administered twice-daily for 7 days Placebo Placebo for ABT-957 Placebo administered twice-daily for 7 days
- Primary Outcome Measures
Name Time Method Pharmacokinetic evaluation of the two ABT-957 diastereomers Day 7 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)
Number of subjects with adverse events Routinely for the duration of the study, about 7 months Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
Site Reference ID/Investigator# 129545
🇺🇸Glendale, California, United States
Site Reference ID/Investigator# 129435
🇺🇸Orlando, Florida, United States
Site Reference ID/Investigator# 144825
🇺🇸Salt Lake City, Utah, United States
Site Reference ID/Investigator# 129641
🇺🇸New York, New York, United States