Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
NCT ID: NCT01549834
Last Updated: 2014-10-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
434 participants
INTERVENTIONAL
2012-03-31
2013-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ABT-126 Low Dose
low dose
ABT-126
Low Dose
ABT-126 High Dose
high dose
ABT-126
High Dose
sugar pill
Placebo
placebo
Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ABT-126
Low Dose
ABT-126
High Dose
placebo
Placebo
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
55 Years
90 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AbbVie (prior sponsor, Abbott)
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Laura Gault, MD
Role: STUDY_DIRECTOR
AbbVie
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Site Reference ID/Investigator# 66523
Bennington, Vermont, United States
Site Reference ID/Investigator# 71793
Gatineau, , Canada
Site Reference ID/Investigator# 71794
Montreal, , Canada
Site Reference ID/Investigator# 71798
Peterborough, , Canada
Site Reference ID/Investigator# 71795
Toronto, , Canada
Site Reference ID/Investigator# 71796
Verdun, , Canada
Site Reference ID/Investigator# 71573
Dijon, , France
Site Reference ID/Investigator# 77833
Limoges, , France
Site Reference ID/Investigator# 68706
Paris, , France
Site Reference ID/Investigator# 68704
Paris, , France
Site Reference ID/Investigator# 68705
Toulouse, , France
Site Reference ID/Investigator# 68768
Berlin, , Germany
Site Reference ID/Investigator# 68764
Freiburg im Breisgau, , Germany
Site Reference ID/Investigator# 68767
Hüttenberg, , Germany
Site Reference ID/Investigator# 69960
Mittweida, , Germany
Site Reference ID/Investigator# 68765
Munich, , Germany
Site Reference ID/Investigator# 69959
Schwerin, , Germany
Site Reference ID/Investigator# 68730
Athens, , Greece
Site Reference ID/Investigator# 68732
Athens, , Greece
Site Reference ID/Investigator# 68733
Athens, , Greece
Site Reference ID/Investigator# 68731
Haidari, Athens, , Greece
Site Reference ID/Investigator# 68729
Thessaloniki, , Greece
Site Reference ID/Investigator# 68735
Thessaloniki, , Greece
Site Reference ID/Investigator# 67586
Belville, , South Africa
Site Reference ID/Investigator# 67582
Cape Town, , South Africa
Site Reference ID/Investigator# 67584
George, , South Africa
Site Reference ID/Investigator# 67585
Johannesburg, , South Africa
Site Reference ID/Investigator# 67583
Rosebank, , South Africa
Site Reference ID/Investigator# 67787
Bath, , United Kingdom
Site Reference ID/Investigator# 67784
Glasgow, , United Kingdom
Site Reference ID/Investigator# 67786
London, , United Kingdom
Site Reference ID/Investigator# 67785
Manchester, , United Kingdom
Site Reference ID/Investigator# 67783
Warrington, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. 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. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2011-004849-40
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M11-793
Identifier Type: -
Identifier Source: org_study_id