Status:
COMPLETED
A Study of ATH-1017 in Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Athira Pharma
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer Disease
Dementia of Alzheimer Type
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
Brief Summary
This study is designed to evaluate treatment effects of ATH-1017 (fosgonimeton) in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.
Detailed Description
This study is designed to assess the correlation of the functional translational biomarker P300 latency and change in ADAS-Cog11 induced by ATH-1017 therapy, over 26-week randomized, double-blind trea...
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)
- 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
- 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
Key Trial Info
Start Date :
November 23 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2022
Estimated Enrollment :
77 Patients enrolled
Trial Details
Trial ID
NCT04491006
Start Date
November 23 2020
End Date
May 20 2022
Last Update
June 12 2023
Active Locations (13)
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1
Syrentis Clinical Research
Santa Ana, California, United States, 92705
2
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
3
iResearch Atlanta
Decatur, Georgia, United States, 30030
4
Neurological Associates of Albany
Albany, New York, United States, 12208