A Study of the Effectiveness of LY3314814 in Patients with Mild Alzheimer's Disease Dementia

Overview

About this study

The purpose of this study is to evaluate the effectiveness of LY3314814 in the treatment of people who have mild Alzheimer's disease dementia.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Must meet the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable Alzheimer's Disease 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
  • Must have a reliable study partner with whom he/she cohabits or has regular contact

Exclusion Criteria

  • 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
    • Cervicocranial vascular disease
  • 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
    • Affect ability to complete the study
  • History of schizophrenia or other chronic psychosis
  • Within 1 year before the screening visit or between screening and randomization, has had 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
    • 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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Jacksonville, Fla.

Mayo Clinic principal investigator

Neill Graff-Radford, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20306926

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