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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01549834
First received: March 7, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: ABT-126
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: Measurements up through 24 weeks ] [ Designated as safety issue: No ]
    An assessment tool which focuses on cognitive function and memory


Secondary Outcome Measures:
  • Mini Mental Status Exam [ Time Frame: Measurements up through 24 weeks ] [ Designated as safety issue: No ]
    Questionnaire which provides a quantitative measure of cognition

  • Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Measurements up through 24 weeks ] [ Designated as safety issue: No ]
    Caregiver-based assessment of activities of daily living

  • DEMentia Quality of Life (DEMQOL) [ Time Frame: Measurements up through 24 weeks ] [ Designated as safety issue: No ]
    Health-related quality of life measurement tool

  • Clinician Interview-Based Impression of Change - plus (CIBIC-plus) [ Time Frame: Measurements up through 24 weeks ] [ Designated as safety issue: No ]
    Measures a global impression of change in severity of dementia

  • Neuropsychiatry Inventory (NPI) [ Time Frame: Measurements up through 24 weeks ] [ Designated as safety issue: No ]
    Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias

  • Partner-Patient Questionnaire for Shared Activities (PPQSA) [ Time Frame: Measurements up through 24 weeks ] [ Designated as safety issue: No ]
    Measures the extent to which mood and mental state interferes with the patient-partner relationship

  • Resource Use in Dementia (RUD-Lite) [ Time Frame: Measurements up through 24 weeks ] [ Designated as safety issue: No ]
    Brief measurement tool for resource utilization

  • EuroQol-5D Questionnaires [ Time Frame: Measurements up through 24 weeks ] [ Designated as safety issue: No ]
    Assesses patient's mobility, self-care, usual activity, pain/discomfort and anxiety/depression

  • Wechsler Memory Scale-III (WMS-III) Working Memory Index [ Time Frame: Measurements up through 18 weeks ] [ Designated as safety issue: No ]
    Assesses working memory


Enrollment: 434
Study Start Date: March 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-126 Low Dose
low dose
Drug: ABT-126
See Arm Description
Experimental: ABT-126 High Dose
high dose
Drug: ABT-126
See Arm Description
Placebo Comparator: sugar pill Drug: placebo
See Arm Description

Detailed 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.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject.
  • The subject is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1. Main Inclusion (Continued):
  • The subject meets the Neurological and Communicative Disorders and Stroke/Alzheimer's Disease 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 at Screening Visit 1.
  • The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit 1.
  • With the exception of a diagnosis of mild-to-moderate Alzheimer's disease and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
  • The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study.

Exclusion Criteria:

  • The subject has taken galantamine or memantine within 60 days prior to Screening Visit 1.
  • The subject has received excluded concomitant medications.
  • The subject has clinically significant abnormal laboratory values at Screening Visit 1 as determined by the investigator.
  • The subject has a history of any significant neurologic disease other than Alzheimer's disease 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 head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
  • In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01549834

  Hide Study Locations
Locations
United States, California
Site Reference ID/Investigator# 66528
Fresno, California, United States, 93720
Site Reference ID/Investigator# 69602
Long Beach, California, United States, 90806
Site Reference ID/Investigator# 66527
San Francisco, California, United States, 94109-4841
United States, Connecticut
Site Reference ID/Investigator# 66530
Hamden, Connecticut, United States, 06518
United States, Florida
Site Reference ID/Investigator# 66522
Delray Beach, Florida, United States, 33445
Site Reference ID/Investigator# 66524
Orlando, Florida, United States, 32806
Site Reference ID/Investigator# 66531
Tampa, Florida, United States, 33613
Site Reference ID/Investigator# 66529
West Palm Beach, Florida, United States, 33407
United States, Illinois
Site Reference ID/Investigator# 66526
Elk Grove Village, Illinois, United States, 60007
United States, New York
Site Reference ID/Investigator# 66525
Staten Island, New York, United States, 10312
United States, Vermont
Site Reference ID/Investigator# 66523
Bennington, Vermont, United States, 05201
Canada
Site Reference ID/Investigator# 71793
Gatineau, Canada, J9A 1K7
Site Reference ID/Investigator# 71794
Montreal, Canada, H3T 1E2
Site Reference ID/Investigator# 71798
Peterborough, Canada, K9H 2P4
Site Reference ID/Investigator# 71795
Toronto, Canada, M3B 2S7
Site Reference ID/Investigator# 71796
Verdun, Canada, H4H 1R3
France
Site Reference ID/Investigator# 71573
Dijon Cedex, France, 21033
Site Reference ID/Investigator# 77833
Limoges Cedex, France, 87042
Site Reference ID/Investigator# 68706
Paris, France, 75013
Site Reference ID/Investigator# 68704
Paris Cedex 10, France, 75475
Site Reference ID/Investigator# 68705
Toulouse Cedex 9, France, 31059
Germany
Site Reference ID/Investigator# 68768
Berlin, Germany, 14050
Site Reference ID/Investigator# 68764
Freiburg, Germany, 79106
Site Reference ID/Investigator# 68767
Huettenberg, Germany, 35625
Site Reference ID/Investigator# 69960
Mittweida, Germany, 09648
Site Reference ID/Investigator# 68765
Munich, Germany, 81675
Site Reference ID/Investigator# 69959
Schwerin, Germany, 19053
Greece
Site Reference ID/Investigator# 68730
Athens, Greece, 115 21
Site Reference ID/Investigator# 68732
Athens, Greece, 151 25
Site Reference ID/Investigator# 68733
Athens, Greece, 15123
Site Reference ID/Investigator# 68731
Haidari, Athens, Greece, 12462
Site Reference ID/Investigator# 68729
Thessaloniki, Greece, 56403
Site Reference ID/Investigator# 68735
Thessaloniki, Greece, 570 10
South Africa
Site Reference ID/Investigator# 67586
Belville, South Africa, 7530
Site Reference ID/Investigator# 67582
Cape Town, South Africa, 7405
Site Reference ID/Investigator# 67584
George, South Africa, 6529
Site Reference ID/Investigator# 67585
Johannesburg, South Africa, 2196
Site Reference ID/Investigator# 67583
Rosebank, South Africa, 2196
United Kingdom
Site Reference ID/Investigator# 67787
Bath, United Kingdom, BA1 3NG
Site Reference ID/Investigator# 67784
Glasgow, United Kingdom, G20 0XA
Site Reference ID/Investigator# 67786
London, United Kingdom, TW8 8DS
Site Reference ID/Investigator# 67785
Manchester, United Kingdom, M8 5R8
Site Reference ID/Investigator# 67783
Warrington, United Kingdom, WA2 8WA
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: Laura Gault, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01549834     History of Changes
Other Study ID Numbers: M11-793, 2011-004849-40
Study First Received: March 7, 2012
Last Updated: November 4, 2013
Health Authority: United States: Food and Drug Administration
United Kingdom: Medicines and Healthcare Products Regulatory Agency
South Africa: Medicines Control Council
Canada: Health Canada
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 28, 2014