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

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

NCT01549834•AbbVie (prior sponsor, Abbott)

View on ClinicalTrials.gov

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 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

Age

55 - 90 years

Sex

ALL

Healthy Volunteers

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.

Locations (43)

Site Reference ID/Investigator# 66528

Fresno, California, United States

Site Reference ID/Investigator# 69602

Long Beach, California, United States

Site Reference ID/Investigator# 66527

San Francisco, California, United States

Site Reference ID/Investigator# 66530

Hamden, Connecticut, United States

Site Reference ID/Investigator# 66522

Delray Beach, Florida, United States

Site Reference ID/Investigator# 66524

Orlando, Florida, United States

Site Reference ID/Investigator# 66531

Tampa, Florida, United States

Site Reference ID/Investigator# 66529

West Palm Beach, Florida, United States

Site Reference ID/Investigator# 66526

Elk Grove Village, Illinois, United States

Site Reference ID/Investigator# 66525

Staten Island, New York, United States

Key Dates

Start Date

March 1, 2012

Primary Completion Date

October 1, 2013

Completion Date

October 1, 2013

Last Updated

October 31, 2014

Enrollment

434

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

ABT-126

DRUG

ABT-126

DRUG

placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 31, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

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