Status:
COMPLETED
ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Athira Pharma
Conditions:
Alzheimer Disease
Dementia of Alzheimer Type
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
PHASE3
Brief Summary
This study is designed to evaluate safety and efficacy of fosgonimeton (ATH-1017) in the treatment of mild to moderate Alzheimer's disease with a randomized treatment duration of 26-weeks.
Detailed Description
The study is designed to evaluate safety and efficacy of ATH-1017 in mild to moderate AD subjects, with randomized, parallel-arm treatment duration of 26 weeks, and based on clinical diagnostic criter...
Eligibility Criteria
Inclusion
- Key
- 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
- 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
Key Trial Info
Start Date :
September 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2024
Estimated Enrollment :
554 Patients enrolled
Trial Details
Trial ID
NCT04488419
Start Date
September 28 2020
End Date
July 15 2024
Last Update
April 4 2025
Active Locations (1)
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1
University of Rochester-AD-CARE Program
Rochester, New York, United States, 14620