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

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:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease Dementia

U.S. FDA Resources

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

Estimated Enrollment:	420
Study Start Date:	March 2012
Estimated Study Completion Date:	October 2013
Estimated 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

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

Show 43 Study Locations

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:	May 17, 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 May 22, 2013