Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Last updated: October 24, 2014
Sponsor: AbbVie (prior sponsor, Abbott)
Overall Status: Completed

Phase

2

Condition

Memory Loss

Dementia

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT01549834
M11-793
2011-004849-40
  • Ages 55-90
  • All Genders

Study Summary

This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The subject and caregiver must voluntarily sign and date an informed consent. If thesubject does not have the capacity to provide informed consent, full informed consentmust be obtained from the subject's representative and assent must be obtained fromthe subject.

  • The subject is a male or female between the ages of 55 and 90 years, inclusive, atScreening Visit 1. Main Inclusion (Continued):

  • The subject meets the Neurological and Communicative Disorders and Stroke/Alzheimer'sDisease and Related Disorders Association (NINCDS/ADRDA) criteria for probable AD.

  • The subject must be receiving a stable dose of an AChEI (donepezil or rivastigmine)for at least 90 days prior to Screening Visit 1.

  • The subject has a Mini-Mental Status Examination (MMSE) total score of 12 to 24,inclusive, at Screening Visit 1.

  • The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 atScreening Visit 1.

  • The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at ScreeningVisit 1.

  • With the exception of a diagnosis of mild-to-moderate Alzheimer's disease and thepresence of stable medical conditions, the subject is in general good health, basedupon the results of medical history, physical examination, vital signs, laboratoryprofile, and a 12-lead electrocardiogram (ECG).

  • The subject has an identified, reliable caregiver who will provide support and ensurecompliance with the study medication and procedures, and provide accurate informationabout the subject's status during the study.

Exclusion

Exclusion Criteria:

  • The subject has taken galantamine or memantine within 60 days prior to Screening Visit
  • The subject has received excluded concomitant medications.

  • The subject has clinically significant abnormal laboratory values at Screening Visit 1as determined by the investigator.

  • The subject has a history of any significant neurologic disease other than Alzheimer'sdisease including Parkinson's disease, multi-infarct or vascular dementia,Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy,multiple sclerosis, any seizures, mental retardation or a history of significant headtrauma followed by persistent neurologic deficits or known structural brainabnormalities.

  • In the opinion of the investigator, the subject has any clinically significantuncontrolled medical or psychiatric illness.

Study Design

Total Participants: 434
Study Start date:
March 01, 2012
Estimated Completion Date:
October 31, 2013

Study Description

This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 420 adults with mild to moderate Alzheimer's disease who are taking stable doses of acetylcholinesterase inhibitors. Subjects will be randomized to one of two ABT-126 dose arms or placebo for a 24-week treatment period.

Connect with a study center

  • Site Reference ID/Investigator# 71793

    Gatineau, J9A 1K7
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 71794

    Montreal, H3T 1E2
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 71798

    Peterborough, K9H 2P4
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 71795

    Toronto, M3B 2S7
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 71796

    Verdun, H4H 1R3
    Canada

    Site Not Available

  • Site Reference ID/Investigator# 71573

    Dijon Cedex, 21033
    France

    Site Not Available

  • Site Reference ID/Investigator# 77833

    Limoges Cedex, 87042
    France

    Site Not Available

  • Site Reference ID/Investigator# 68706

    Paris, 75013
    France

    Site Not Available

  • Site Reference ID/Investigator# 68704

    Paris Cedex 10, 75475
    France

    Site Not Available

  • Site Reference ID/Investigator# 68705

    Toulouse Cedex 9, 31059
    France

    Site Not Available

  • Site Reference ID/Investigator# 68768

    Berlin, 14050
    Germany

    Site Not Available

  • Site Reference ID/Investigator# 68764

    Freiburg, 79106
    Germany

    Site Not Available

  • Site Reference ID/Investigator# 68767

    Huettenberg, 35625
    Germany

    Site Not Available

  • Site Reference ID/Investigator# 69960

    Mittweida, 09648
    Germany

    Site Not Available

  • Site Reference ID/Investigator# 68765

    Munich, 81675
    Germany

    Site Not Available

  • Site Reference ID/Investigator# 69959

    Schwerin, 19053
    Germany

    Site Not Available

  • Site Reference ID/Investigator# 68730

    Athens, 115 21
    Greece

    Site Not Available

  • Site Reference ID/Investigator# 68732

    Athens, 151 25
    Greece

    Site Not Available

  • Site Reference ID/Investigator# 68733

    Athens, 15123
    Greece

    Site Not Available

  • Site Reference ID/Investigator# 68731

    Haidari, Athens, 12462
    Greece

    Site Not Available

  • Site Reference ID/Investigator# 68729

    Thessaloniki, 56403
    Greece

    Site Not Available

  • Site Reference ID/Investigator# 68735

    Thessaloniki, 570 10
    Greece

    Site Not Available

  • Site Reference ID/Investigator# 67586

    Belville, 7530
    South Africa

    Site Not Available

  • Site Reference ID/Investigator# 67582

    Cape Town, 7405
    South Africa

    Site Not Available

  • Site Reference ID/Investigator# 67584

    George, 6529
    South Africa

    Site Not Available

  • Site Reference ID/Investigator# 67585

    Johannesburg, 2196
    South Africa

    Site Not Available

  • Site Reference ID/Investigator# 67583

    Rosebank, 2196
    South Africa

    Site Not Available

  • Site Reference ID/Investigator# 67787

    Bath, BA1 3NG
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 67784

    Glasgow, G20 0XA
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 67786

    London, TW8 8DS
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 67785

    Manchester, M8 5RB
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 67783

    Warrington, WA2 8WA
    United Kingdom

    Site Not Available

  • Site Reference ID/Investigator# 66528

    Fresno, California 93720
    United States

    Site Not Available

  • Site Reference ID/Investigator# 69602

    Long Beach, California 90806
    United States

    Site Not Available

  • Site Reference ID/Investigator# 66527

    San Francisco, California 94109-4841
    United States

    Site Not Available

  • Site Reference ID/Investigator# 66530

    Hamden, Connecticut 06518
    United States

    Site Not Available

  • Site Reference ID/Investigator# 66522

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Site Reference ID/Investigator# 66524

    Orlando, Florida 32806
    United States

    Site Not Available

  • Site Reference ID/Investigator# 66531

    Tampa, Florida 33613
    United States

    Site Not Available

  • Site Reference ID/Investigator# 66529

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Site Reference ID/Investigator# 66526

    Elk Grove Village, Illinois 60007
    United States

    Site Not Available

  • Site Reference ID/Investigator# 66525

    Staten Island, New York 10312
    United States

    Site Not Available

  • Site Reference ID/Investigator# 66523

    Bennington, Vermont 05201
    United States

    Site Not Available

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