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
Overview
- Phase
- Phase 1
- Intervention
- ABT-957
- Conditions
- Alzheimer's Disease
- Sponsor
- AbbVie
- Enrollment
- 19
- Locations
- 4
- Primary Endpoint
- Pharmacokinetic evaluation of the two ABT-957 diastereomers
- Status
- Terminated
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility 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.
Arms & Interventions
ABT-957
ABT-957 administered twice-daily for 7 days
Intervention: ABT-957
Placebo
Placebo administered twice-daily for 7 days
Intervention: Placebo for ABT-957
Outcomes
Primary Outcomes
Pharmacokinetic evaluation of the two ABT-957 diastereomers
Time Frame: 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
Time Frame: 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