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

December 9, 2013 updated by: AbbVie

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

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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Florida
      • Miami, Florida, United States, 33169
        • Site Reference ID/Investigator# 106999
      • Orlando, Florida, United States, 32806
        • Site Reference ID/Investigator# 106998
    • Kansas
      • Overland Park, Kansas, United States, 66212
        • Site Reference ID/Investigator# 107000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group 1, low dose
ABT-354
Placebo
ABT-354 Low Dose
ABT-354 High Dose
EXPERIMENTAL: Group 2, high dose
ABT-354
Placebo
ABT-354 Low Dose
ABT-354 High Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vital signs
Time Frame: Up to Day 10
Up to Day 10
ECG (electrocardiogram)
Time Frame: Up to Day 10
Up to Day 10
Neurological exam
Time Frame: Up to Day 10
Up to Day 10
Laboratory tests
Time Frame: Up to Day 10
Hematology, Chemistry, Urinalysis
Up to Day 10
Number of subject with adverse events
Time Frame: Up to Day 10
Up to Day 10
C-SSRS (Columbia-Suicide Severity Rating Scale)
Time Frame: Up to Day 10
Up to Day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters
Time Frame: Up to Day 10
Cmax, Cmin, Tmax, AUC, t-1/2, CL/F
Up to Day 10

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2013

Primary Completion (ACTUAL)

November 1, 2013

Study Completion (ACTUAL)

November 1, 2013

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 23, 2013

First Posted (ESTIMATE)

July 25, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 9, 2013

Last Verified

December 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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