Clinical Trials/NCT01527916

NCT01527916

Completed

Phase 2

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

AbbVie (prior sponsor, Abbott)33 sites in 6 countries438 target enrollmentFebruary 2012

ConditionsAlzheimer's Disease

Interventionsplacebo donepezil ABT-126

Drugsplacebo donepezil ABT-126

Overview

Phase: Phase 2
Intervention: placebo
Conditions: Alzheimer's Disease
Sponsor: AbbVie (prior sponsor, Abbott)
Enrollment: 438
Locations: 33
Primary Endpoint: Alzheimer's Disease Assessment Scale - cognitive subscale
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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.

Registry

clinicaltrials.gov

Start Date

February 2012

End Date

November 2013

Last Updated

11 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AbbVie (prior sponsor, Abbott)

Responsible Party

Sponsor

Eligibility 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
•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
•The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit
•The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit
•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.

Arms & Interventions

sugar pill

Intervention: placebo

donepezil

Intervention: donepezil

ABT-126 Low Dose

low dose

Intervention: ABT-126

ABT-126 Middle Dose

middle dose

Intervention: ABT-126

ABT-126 high dose

high dose

Intervention: ABT-126

Outcomes

Primary Outcomes

Alzheimer's Disease Assessment Scale - cognitive subscale

Time Frame: Measurements up through 24 weeks

Secondary Outcomes

Clinician Interview-Based Impression of Change - plus (CIBIC-plus)(Measurements up through 24 weeks)
Neuropsychiatry Inventory (NPI)(Measurements up through 24 weeks)
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)(Measurements up through 24 weeks)
Mini Mental Status Exam (MMSE)(Measurements up through 24 weeks)
DEMentia Quality of Life (DEMQOL)(Measurements up through 24 weeks)
Partner-Patient Questionnaire for Shared Activities (PPQSA)(Measurements up through 24 weeks)
Resource Use in Dementia (RUD-Lite)(Measurements up through 24 weeks)
EuroQol-5D Questionnaires(Measurements up through 24 weeks)
Wechsler Memory Scale-III (WMS-III) Working Memory Index(Measurements up through 24 weeks)