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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01527916
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : November 19, 2014
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: placebo Drug: donepezil Drug: ABT-126 Phase 2

Detailed Description:
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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 438 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2012
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Donepezil

Arm Intervention/treatment
Placebo Comparator: sugar pill Drug: placebo
Placebo Comparator

Active Comparator: donepezil Drug: donepezil
Active Comparator

Experimental: ABT-126 Low Dose
low dose
Drug: ABT-126
low dose, middle dose, high dose

Experimental: ABT-126 Middle Dose
middle dose
Drug: ABT-126
low dose, middle dose, high dose

Experimental: ABT-126 high dose
high dose
Drug: ABT-126
low dose, middle dose, high dose

Primary Outcome Measures :
  1. Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: Measurements up through 24 weeks ]

Secondary Outcome Measures :
  1. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: Measurements up through 24 weeks ]
    Caregiver-based assessment of activities of daily living

  2. Mini Mental Status Exam (MMSE) [ Time Frame: Measurements up through 24 weeks ]
    Questionnaire which provides a quantitative measure of cognition

  3. DEMentia Quality of Life (DEMQOL) [ Time Frame: Measurements up through 24 weeks ]
    Health-related quality of life measurement tool

  4. Clinician Interview-Based Impression of Change - plus (CIBIC-plus) [ Time Frame: Measurements up through 24 weeks ]
    Measures a global impression of change in severity of dementia

  5. Neuropsychiatry Inventory (NPI) [ Time Frame: Measurements up through 24 weeks ]
    Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias

  6. Partner-Patient Questionnaire for Shared Activities (PPQSA) [ Time Frame: Measurements up through 24 weeks ]
    Measures the extent to which mood and mental state interferes with the patient-partner relationship

  7. Resource Use in Dementia (RUD-Lite) [ Time Frame: Measurements up through 24 weeks ]
    Brief measurement tool for resource utilization

  8. EuroQol-5D Questionnaires [ Time Frame: Measurements up through 24 weeks ]
    Assesses patient's mobility, self-care, usual activity, pain/discomfort and anxiety/depression

  9. Wechsler Memory Scale-III (WMS-III) Working Memory Index [ Time Frame: Measurements up through 24 weeks ]
    Assesses working memory

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01527916

  Hide Study Locations
United States, Florida
Site Reference ID/Investigator# 56503
Delray Beach, Florida, United States, 33445
Site Reference ID/Investigator# 56518
Tampa, Florida, United States, 33613
Site Reference ID/Investigator# 56514
West Palm Beach, Florida, United States, 33407
United States, Illinois
Site Reference ID/Investigator# 62611
Elk Grove Village, Illinois, United States, 60007
United States, New York
Site Reference ID/Investigator# 56506
Staten Island, New York, United States, 10312
United States, Pennsylvania
Site Reference ID/Investigator# 82994
Jenkintown, Pennsylvania, United States, 19046
United States, Texas
Site Reference ID/Investigator# 77636
Wichita Falls, Texas, United States, 76309
United States, Vermont
Site Reference ID/Investigator# 56504
Bennington, Vermont, United States, 05201
Site Reference ID/Investigator# 62565
Gdynia, Poland, 81-361
Site Reference ID/Investigator# 62563
Poznan, Poland, 61-853
Site Reference ID/Investigator# 62562
Szczecin, Poland, 71-215
Russian Federation
Site Reference ID/Investigator# 60945
Kazan, Russian Federation, 420012
Site Reference ID/Investigator# 60955
Kazan, Russian Federation, 420097
Site Reference ID/Investigator# 60954
Kirov, Russian Federation, 610014
Site Reference ID/Investigator# 60951
Moscow, Russian Federation, 119048
Site Reference ID/Investigator# 60959
Moscow, Russian Federation, 123995
Site Reference ID/Investigator# 60946
Novosibirsk, Russian Federation, 630064
Site Reference ID/Investigator# 60950
Saratov, Russian Federation, 410060
Site Reference ID/Investigator# 60947
St. Petersburg, Russian Federation, 190020
Site Reference ID/Investigator# 60958
St. Petersburg, Russian Federation, 190103
Site Reference ID/Investigator# 60949
St. Petersburg, Russian Federation, 192019
Site Reference ID/Investigator# 60952
St. Petersburg, Russian Federation, 198510
South Africa
Site Reference ID/Investigator# 60911
Belville, South Africa, 7530
Site Reference ID/Investigator# 76073
Cape Town, South Africa, 7925
Site Reference ID/Investigator# 60912
George, South Africa, 6529
Site Reference ID/Investigator# 60910
Johannesburg, South Africa, 2196
Site Reference ID/Investigator# 60909
Donetsk, Ukraine, 83037
Site Reference ID/Investigator# 60906
Kiev, Ukraine, 04112
Site Reference ID/Investigator# 60905
Poltava, Ukraine, 36006
United Kingdom
Site Reference ID/Investigator# 60960
Bath, United Kingdom, BA1 3NG
Site Reference ID/Investigator# 60963
Blackburn, United Kingdom, BB2 3HH
Site Reference ID/Investigator# 60962
Glasgow, United Kingdom, G20 0XA
Site Reference ID/Investigator# 60961
London, United Kingdom, TW8 8DS
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Laura Gault, MD AbbVie

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01527916     History of Changes
Other Study ID Numbers: M10-985
2011-002004-32 ( EudraCT Number )
First Posted: February 7, 2012    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents