Overview

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