A Study of Lanabecestat (LY3314814) in Participants With Mild Alzheimer's Disease Dementia

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

The main purpose of this study is to evaluate the efficacy of the study drug known as lanabecestat in participants with mild Alzheimer's disease (AD) dementia.

Key facts

Study ID

NCT02783573

Run by

AstraZeneca

People needed

1722

Starts

2016-07-01

Expected to finish

2018-09-28

Last updated by the study team

2019-12-03

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant must meet the National Institute on Aging (NIA) and the Alzheimer's Association (AA) (NIA-AA) criteria for probable AD dementia.
• MMSE score of 20 to 26 inclusive at screening visit.
• For a diagnosis of mild AD dementia, participant must have a CDR global score of 0.5 or 1, with the memory box score ≥0.5 at screening.
• Evidence of amyloid pathology.
• The participant must have a reliable study partner with whom he/she cohabits or has regular contact.

You may not qualify if…

• Significant and/or current 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, repetitive head trauma, serious infection of the brain, Parkinson's disease, epilepsy, or cervicocranial vascular disease.
• Participants with 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 assessment, or affect the participant's ability to complete the study. Participants with history of schizophrenia or other chronic psychosis are excluded.
• Within 1 year before the screening visit or between screening and randomization, any of the following: myocardial infarction; moderate or severe congestive heart failure, New York Heart Association class III or IV; hospitalization for, or symptoms of, unstable angina; syncope due to orthostatic hypotension or unexplained syncope; known significant structural heart disease (such as, significant valvular disease, hypertrophic cardiomyopathy); or hospitalization for arrhythmia.
• Congenital QT prolongation.
• Intermittent second- or third-degree atrioventricular (AV) heart block or AV dissociation or history of ventricular tachycardia.
• A corrected QT (QTcF) interval measurement >470 milliseconds (men and women) at screening (as determined at the investigational site).
• History of malignant cancer within the last 5 years.
• History of vitiligo and/or current evidence of post-inflammatory hypopigmentation.
• Calculated creatinine clearance <30 milliliters per minute (Cockcroft-Gault formula; Cockcroft and Gault 1976) at screening.
• Currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Where it is running

• St Josephs Hospital and Medical Center — Phoenix, Arizona, United States
• Four Peaks Neurology — Scottsdale, Arizona, United States
• Arizona Neurology — Scottsdale, Arizona, United States
• Center for Neurosciences — Tucson, Arizona, United States
• NEA Baptist Clinical — Jonesboro, Arkansas, United States
• The Research Center of Southern California — Carlsbad, California, United States
• WCCT Global — Costa Mesa, California, United States
• Neuro-Pain Medical Center — Fresno, California, United States
• Neurology Center of North Orange County — Fullerton, California, United States
• Pacific Neuroscience Medical Group — Oxnard, California, United States
• California Research Foundation — San Diego, California, United States
• Pacific Research Network Inc — San Diego, California, United States
• Sharp Mesa Vista Hospital — San Diego, California, United States
• Syrentis Clinical Research — Santa Ana, California, United States
• Care Access Research — Santa Clarita, California, United States
• California Neuroscience Research — Sherman Oaks, California, United States
• Care Access Research — Valencia, California, United States
• Associated Neurologists, PC - Danbury — Danbury, Connecticut, United States
• Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Research Center for Clinical Studies, Inc — Norwalk, Connecticut, United States
• JEM Research Institute — Atlantis, Florida, United States
• Morton Plant Hospital — Clearwater, Florida, United States
• Brain Matters Research — Delray Beach, Florida, United States
• Xenoscience — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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