Clinical trial NCT02220738: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-08-20
Enrollment: 19
Sex: ALL
Minimum age (years): 55
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Pharmacokinetic evaluation of the two ABT-957 diastereomers
timeFrame: Day 7
measure: Number of subjects with adverse events
timeFrame: Routinely for the duration of the study, about 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Site Reference ID/Investigator# 129545
state: California
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 129435
state: Florida
city: New York
country: United States
facility: Site Reference ID/Investigator# 129641
state: New York
city: Salt Lake City
country: United States
facility: Site Reference ID/Investigator# 144825
state: Utah
Study officials:
affiliation: AbbVie
name: Nuno Mendonca, MD
role: STUDY_DIRECTOR
References:
citation: Lon HK, Mendonca N, Goss S, Othman AA, Locke C, Jin Z, Rendenbach-Mueller B. Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Alicapistat, a Selective Inhibitor of Human Calpains 1 and 2 for the Treatment of Alzheimer Disease: An Overview of Phase 1 Studies. Clin Pharmacol Drug Dev. 2019 Apr;8(3):290-303. doi: 10.1002/cpdd.598. Epub 2018 Jul 27.