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Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

NCT ID: NCT01908010

Last Updated: 2013-12-11

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

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2013-11-30

Brief Summary

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This study will investigate safety, tolerability and pharmacokinetics of ABT-354 in up to 20 male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.

Detailed Description

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This is a double-blind, placebo-controlled, randomized, multiple-dose, multicenter study. Up to 20 male and female subjects with mild to moderate Alzheimer's disease (AD) who are taking stable doses of acetylcholinesterase inhibitors will be enrolled in this study. Within 28 days prior to study drug administration, subjects will be screened based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD, Mini-Mental State Examination (MMSE) and Modified Hachinski Ischemic Scale (MHIS) scores, medical history, physical examination, neurological examination, vital signs, ECG, laboratory tests and response to Columbia-Suicide Severity Rating Scale (C-SSRS).

The study will be performed in two groups of 10 subjects each. In each group of 10 subjects, 7 subjects will be randomly assigned to receive ABT-354 and 3 subjects to receive matching placebo.

Conditions

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Alzheimer's Disease

Keywords

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Alzheimer's disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group 1, low dose

ABT-354

Group Type EXPERIMENTAL

ABT-354

Intervention Type DRUG

ABT-354 Low Dose

Placebo

Intervention Type DRUG

Placebo

Group 2, high dose

ABT-354

Group Type EXPERIMENTAL

ABT-354

Intervention Type DRUG

ABT-354 High Dose

Placebo

Intervention Type DRUG

Placebo

Interventions

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ABT-354

ABT-354 Low Dose

Intervention Type DRUG

ABT-354

ABT-354 High Dose

Intervention Type DRUG

Placebo

Placebo

Intervention Type DRUG

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
* Has a Mini-Mental State Examination total score of 16 to 26, inclusive, at Screening
* Has a Modified Hachinski Ischemia Scale score of ≤ 4 at Screening
* On a stable dose of - donepezil, galantamine or rivastigmine for at least 30 days prior to study drug administration
* Has had a computerized tomography or magnetic resonance imaging scan, interpreted by a radiologist or neurologist, within 36 months prior to randomization

Exclusion Criteria

* Receipt of any depot drug by injection within 30 days prior to study drug administration
* Receipt of an investigational product within a time period equal to 10 half-lives, if known, or within 6 weeks prior to study drug administration
* History of any significant neurological disease other than Alzheimer's Disease
* History of significant sensitivity or allergy to multiple drugs based on medical records and/or the opinion of the investigator
* Significant current - suicidal ideation within 1 month prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale completed at Screening or any history of suicide attempts
Minimum Eligible Age

55 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gerard Marek, MD

Role: STUDY_DIRECTOR

AbbVie

Locations

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Site Reference ID/Investigator# 106999

Miami, Florida, United States

Site Status

Site Reference ID/Investigator# 106998

Orlando, Florida, United States

Site Status

Site Reference ID/Investigator# 107000

Overland Park, Kansas, United States

Site Status

Countries

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United States

Other Identifiers

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M13-080

Identifier Type: -

Identifier Source: org_study_id