Status:
TERMINATED
Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
Lead Sponsor:
Athira Pharma
Conditions:
Alzheimer Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE2
PHASE3
Brief Summary
The objective of this study is to determine the safety and tolerability of fosgonimeton (ATH-1017) in subjects with mild to moderate Alzheimer's disease who completed the 26-week randomized treatment ...
Detailed Description
This is a multicenter, seamless, open-label extension (OLEX) study of ATH-1017 treatment in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease who completed 26 weeks treatment ...
Eligibility Criteria
Inclusion
- Subject has completed the Week 26 visit of either of the two blinded parent studies (ATH-1017-AD-0201 or ATH-1017-AD-0202).
- Reliable and capable support person/caregiver who is willing to accept responsibility for supervising the daily treatment or, if required, administering study drug.
- Subject capable of giving signed informed consent, or by a legally acceptable representative.
- Subjects must be in generally good health.
- Male subjects and their partners must agree to continue to use a double-barrier method of contraception during the study, including the follow-up period, unless the partner is not of childbearing potential.
Exclusion
- Subject has experienced a serious adverse event during the parent study, which could present an increased safety risk during the open label extension.
- New diagnosis of severe major depressive disorder even without psychotic features.
- Any subject with formalized delusions or hallucinations.
- Significant suicide risk.
- Newly-diagnosed malignant tumor, except for the following conditions that are stable in the judgement of the investigator:
- Adequately treated squamous and basal cell carcinoma, or squamous and basal cell carcinoma in situ
- Prostate carcinoma in situ
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2024
Estimated Enrollment :
423 Patients enrolled
Trial Details
Trial ID
NCT04886063
Start Date
June 30 2021
End Date
October 23 2024
Last Update
April 1 2025
Active Locations (1)
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1
University of Rochester-AD-CARE Program
Rochester, New York, United States, 14620