Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01527916
First received: February 3, 2012
Last updated: November 19, 2013
Last verified: November 2013

February 3, 2012
November 19, 2013
February 2012
November 2013   (final data collection date for primary outcome measure)
Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: Measurements up through 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01527916 on ClinicalTrials.gov Archive Site
  • 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
  • Mini Mental Status Exam (MMSE) [ Time Frame: Measurements up through 24 weeks ] [ Designated as safety issue: No ]
    Questionnaire which provides a quantitative measure of cognition
  • 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 24 weeks ] [ Designated as safety issue: No ]
    Assesses working memory
  • 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
  • Mini Mental Status Exam (MMSE) [ Time Frame: Measurements up through 24 weeks ] [ Designated as safety issue: No ]
    Questionnaire which provides a quantitative measure of cognition
  • 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 psychopatholgy 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 24 weeks ] [ Designated as safety issue: No ]
    Assesses working memory
Not Provided
Not Provided
 
Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease
A Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease

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

This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 410 adults with mild to moderate Alzheimer's disease. Subjects will be randomized to one of 5 treatment groups (ABT-126, donepezil or placebo) for a 24-week treatment period.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: placebo
    See Arm Description
  • Drug: donepezil
    See Arm Description
  • Drug: ABT-126
    low dose, middle dose, high dose
  • Placebo Comparator: sugar pill
    Intervention: Drug: placebo
  • Active Comparator: donepezil
    Intervention: Drug: donepezil
  • Experimental: ABT-126 Low Dose
    low dose
    Intervention: Drug: ABT-126
  • Experimental: ABT-126 Middle Dose
    middle dose
    Intervention: Drug: ABT-126
  • Experimental: ABT-126 high dose
    high dose
    Intervention: Drug: ABT-126
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
438
November 2013
November 2013   (final data collection date for primary outcome measure)

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.
  • The subject meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease.
  • The subject has a Mini-Mental Status Examination (MMSE) total score of 10 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 AD 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 is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1, or is participating in cognitive therapy for the treatment of Alzheimer's disease or dementia.
  • 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.
  • The subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.
Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Ukraine,   South Africa,   Russian Federation,   United Kingdom,   Poland
 
NCT01527916
M10-985, 2011-002004-32
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Laura Gault, MD AbbVie
AbbVie
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP