AMARANTH

Phase 2

• Conditions: Alzheimer's Disease

• Registration Number: JPRN-jRCT2080222853
• Lead Sponsor: AstraZeneca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-05-21
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Gradual and progressive change in the patient's memory function over more
than 6 months, reported by patient and study partner

-MMSE score of 20-30 inclusive at screening visit

-Objective impairment in memory as evaluated by memory test performed at screening visit

-For a diagnosis of mild Alzheimer's Disease (AD), patient 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, patient meets NIA-AA criteria for MCI due to AD

Exclusion Criteria

-Significant neurological disease affecting the CNS, 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 yrs

-Patients 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 patient's ability to complete the study

-History of alcohol or drug abuse or dependence (except nicotine dependence) within 2 yrs before the screening visit

-Within 1 yr before the screening visit or between screening and baseline, any of the following: myocardial infarction; moderate or severe congestive heart failure, NYHA 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 yrs, with the exception of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical, or non-progressive prostate cancer

-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 patient's safety or ability to complete the study, incl hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, or hematologic disorders

Study & Design

• Study Type: Interventional
• Study Design: Not specified