A Translational Study of ATH-1017 in Mild to Moderate Alzheimer's Disease

• Status: Active, not recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to evaluate treatment effects of ATH-1017 in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Athira Pharma
• Collaborator: National Institute on Aging (NIA)

Criteria

Key Inclusion Criteria:

• Age 55 to 85 years

• Mild-to-moderate AD dementia subjects, MMSE 14-24, CDR 1 or 2 at Screening

• Clinical diagnosis of dementia, due probably to AD, by Revised National Institute on Aging-Alzheimer's Association criteria (McKhann, 2011)

• Reliable and capable support person/caregiver

• Treatment-free or receiving stable acetylcholinesterase inhibitor (AChEI) treatment, defined as:

• Treatment-naïve, OR

• Subjects are on a stable, approved dose of an AChEI (except for donepezil at 23 mg PO) for at least 3 months before Screening OR

• Subjects who received an AChEI in the past and discontinued 4 weeks prior to Screening

Key Exclusion Criteria:

• History of significant neurologic disease, other than AD, that may affect cognition, or concurrent with the onset of dementia

• History of unexplained loss of consciousness, and epileptic fits (unless febrile)

• Subject has atypical variant presentation of AD, if known from medical history, particularly non-amnestic AD

• History of brain MRI scan indicative of any other significant abnormality

• Hearing test result considered unacceptable for auditory ERP P300 assessment

• Diagnosis of severe major depressive disorder even without psychotic features

• Significant suicide risk

• History within 2 years of Screening, or current diagnosis of psychosis

• Myocardial infarction or unstable angina within the last 6 months

• Clinically significant (in the judgment of the investigator) cardiac arrhythmia (including atrial fibrillation), cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)

• Subject has either hypertension (supine diastolic blood pressure > 95 mmHg), or symptomatic hypotension in the judgment of the investigator

• Clinically significant ECG abnormality at Screening

• Renal insufficiency (serum creatinine > 2.0 mg/dL)

• Hepatic impairment with alanine aminotransferase or aspartate aminotransferase > 2 times the upper limit of normal, or Child-Pugh class B and C

• Malignant tumor within 3 years before Screening

• Memantine in any form, combination or dosage within 4 weeks prior to Screening

• Donepezil at 23 mg PO

• The subject has received active amyloid or tau immunization (i.e., vaccination for Alzheimer's disease) at any time, or passive immunization (i.e., monoclonal antibodies for Alzheimer's disease) within 6 months of Screening