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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ABT-957

ABT-957 administered twice-daily for 7 days

Group Type EXPERIMENTAL

ABT-957

Intervention Type DRUG

ABT-957 administered twice-daily for 7 days

Placebo

Placebo administered twice-daily for 7 days

Group Type PLACEBO_COMPARATOR

Placebo for ABT-957

Intervention Type OTHER

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

Interventions

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ABT-957

ABT-957 administered twice-daily for 7 days

Intervention Type DRUG

Placebo for ABT-957

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

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No