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

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02220738

Enrollment

Registered

2014-08-20

Start date

2014-09-30

Completion date

2016-03-31

Last updated

2021-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease

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.

Interventions

DRUGABT-957

ABT-957 administered twice-daily for 7 days

OTHERPlacebo for ABT-957

Placebo for ABT-957 administered twice-daily for 7 days

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

55 Years to 90 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026