Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease
This study is currently recruiting participants.
Verified April 2013 by AbbVie
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01527916
First received: February 3, 2012
Last updated: April 19, 2013
Last verified: April 2013
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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: placebo Drug: donepezil Drug: ABT-126 |
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 and Active-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease |
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 ]
Secondary Outcome Measures:
- 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
| Estimated Enrollment: | 410 |
| Study Start Date: | February 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: sugar pill |
Drug: placebo
See Arm Description
|
| Active Comparator: donepezil |
Drug: donepezil
See Arm Description
|
|
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
|
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.
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.
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527916
Show 34 Study Locations
Contacts
| Contact: Linda Balen, MS | 847-936-0475 | linda.balen@abbvie.com |
| Contact: Lindsey Bensman, BS | 847-935-1821 | lindsey.bensman@abbvie.com |
Show 34 Study LocationsSponsors 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: | NCT01527916 History of Changes |
| Other Study ID Numbers: | M10-985, 2011-002004-32 |
| Study First Received: | February 3, 2012 |
| Last Updated: | April 19, 2013 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration United Kingdom: Research Ethics Committee Russia: FSI Scientific Center of Expertise of Medical Application Ukraine: Ministry of Health Ukraine: Ethics Committee South Africa: Medicines Control Council South Africa: Human Research Ethics Committee Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Russia: Ministry of Health of the Russian Federation |
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 Donepezil |
Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 22, 2013