Open-Label Extension of Studies ATH-1017-AD-0201 and ATH-1017-AD-0202 in Subjects With Mild to Moderate Alzheimer's Disease
Open-Label Extension of Studies ATH-1017-AD-0201 and ATH-1017-AD-0202 in Subjects With Mild to Moderate Alzheimer's Disease
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 in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202.
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 in the randomized, placebo-controlled, double-blind studies, ATH-1017-AD-0201 and ATH-1017-AD-0202. This OLEX study will provide additional, longer-term safety and tolerability information on ATH-1017 administration up to 48 months in subjects with mild to moderate Alzheimer's disease.
Inclusion Criteria:
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: