Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease
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|ClinicalTrials.gov Identifier: NCT01527916|
Recruitment Status : Completed
First Posted : February 7, 2012
Last Update Posted : November 19, 2014
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|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: placebo Drug: donepezil Drug: ABT-126||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||438 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|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|
|Placebo Comparator: sugar pill||
|Active Comparator: donepezil||
Experimental: ABT-126 Low Dose
low dose, middle dose, high dose
Experimental: ABT-126 Middle Dose
low dose, middle dose, high dose
Experimental: ABT-126 high dose
low dose, middle dose, high dose
- Alzheimer's Disease Assessment Scale - cognitive subscale [ Time Frame: Measurements up through 24 weeks ]
- 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
- Mini Mental Status Exam (MMSE) [ Time Frame: Measurements up through 24 weeks ]Questionnaire which provides a quantitative measure of cognition
- DEMentia Quality of Life (DEMQOL) [ Time Frame: Measurements up through 24 weeks ]Health-related quality of life measurement tool
- 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
- Neuropsychiatry Inventory (NPI) [ Time Frame: Measurements up through 24 weeks ]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 ]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 ]Brief measurement tool for resource utilization
- EuroQol-5D Questionnaires [ Time Frame: Measurements up through 24 weeks ]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 ]Assesses working memory
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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|
- 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.
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT01527916
|Study Director:||Laura Gault, MD||AbbVie|
|Responsible Party:||AbbVie (prior sponsor, Abbott)|
|Other Study ID Numbers:||
2011-002004-32 ( EudraCT Number )
|First Posted:||February 7, 2012 Key Record Dates|
|Last Update Posted:||November 19, 2014|
|Last Verified:||November 2014|
Central Nervous System Diseases
Nervous System Diseases
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs