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

AbbVie

Status and phase

Terminated

Phase 1

Conditions

Alzheimer's Disease

Treatments

Other: Placebo for ABT-957

Drug: ABT-957

Study type

Interventional

Funder types

Industry

Identifiers

NCT02220738

M13-334

Details and patient eligibility

About

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.

Enrollment

19 patients

Sex

All

Ages

55 to 90 years old

Volunteers

No 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.