Status:
TERMINATED
An Efficacy and Safety Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Eli Lilly and Company
Conditions:
Alzheimer´s Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
PHASE3
Brief Summary
The purpose of this study is to assess the efficacy and safety of lanabecestat compared with placebo administered for 104 weeks in the treatment of early Alzheimer´s disease. The study will test the h...
Detailed Description
Participants who meet other study entry requirements will be required to undergo either an amyloid positron emission tomography (PET) scan or a lumbar puncture for cerebrospinal fluid (CSF) sampling a...
Eligibility Criteria
Inclusion
- Gradual and progressive change in the participant's memory function over more than 6 months, reported by participant and study partner
- Mini-Mental State Examination score of 20-30 inclusive at screening
- Objective impairment in memory as evaluated by memory test performed at screening
- For a diagnosis of mild Alzheimer's Disease (AD), participant meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable AD
- For a diagnosis of MCI due to AD, participant meets NIA-AA criteria for MCI due to AD
Exclusion
- Significant neurological disease affecting the central nervous system, other than AD, that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson´s disease, or epilepsy or recurrent seizures
- History of clinically evident stroke, or multiple strokes based on history or imaging results
- History of clinically important carotid or vertebrobasilar stenosis or plaque
- History of multiple concussions with sustained cognitive complaints or objective change in neuropsychological function in the last 5 years
- Participants with a current Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition diagnosis of Major Depressive Disorder or any current primary psychiatric diagnosis other than AD if, in the judgment of the investigator, the psychiatric disorder or symptom is likely to confound interpretation of drug effect, affect cognitive assessments, or affect the participant´s ability to complete the study
- History of alcohol or drug abuse or dependence (except nicotine dependence) within 2 years before the screening
- Within 1 year before the screening or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptom of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (eg, significant valvular disease, hypertrophic cardiomyopathy), or hospitalization for arrhythmia
- Congenital QT prolongation
- History of cancer within the last 5 years, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, non-progressive prostate cancer or other cancers with low-risk of recurrence or spread
- Current serious or unstable clinically important systemic illness that, in the judgment of the investigator, is likely to affect cognitive assessment, deteriorate, or affect the participant's safety or ability to complete the study, including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders
Key Trial Info
Start Date :
September 30 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 4 2018
Estimated Enrollment :
2218 Patients enrolled
Trial Details
Trial ID
NCT02245737
Start Date
September 30 2014
End Date
October 4 2018
Last Update
December 3 2019
Active Locations (254)
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1
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
2
St Josephs Hospital and Medical Center
Phoenix, Arizona, United States, 85013
3
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
4
Territory Neurology & Research Institute
Tucson, Arizona, United States, 85704