ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
Sponsored by Athira Pharma
About this trial
Last updated 7 months ago
Study ID
Status
Type
Phase
Placebo
Accepting
Not accepting
Trial Timing
Ended a year ago
What is this trial about?
What are the Participation Requirements?
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)
- Body mass index (BMI) of ≥ 18 and ≤ 35 kg/m2 at Screening
- Reliable and capable support person/caregiver
- Treatment-free (subjects not receiving acetylcholinesterase inhibitor [AChEI]
treatment), defined as:
- Treatment-naïve, OR
- Subjects who received an AChEI in the past and discontinued at least 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
- 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
- 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 cardiac arrhythmia (including atrial fibrillation),
cardiomyopathy, or cardiac conduction defect (note: pacemaker is acceptable)
- Subject has either hypertension or symptomatic hypotension
- Clinically significant ECG abnormality at Screening
- Chronic kidney disease with estimated glomerular filtration rate (eGFR) <45 mL/min
- 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
- Acetylcholinesterase inhibitors in any dosage form
- 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