Overview
Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease
Status:
Enrolling by invitation
Enrolling by invitation
Trial end date:
2023-05-01
2023-05-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The objective of this study is to determine the safety and tolerability of ATH-1017 in subjects with mild to moderate Alzheimer's disease who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202.Phase:
Phase 2Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Athira Pharma
Criteria
Inclusion Criteria:- 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 Criteria:
- 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