Open Label Study of ATH-1017 for Treatment of Mild to Moderate Alzheimer's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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 30 months in subjects with mild to moderate Alzheimer's disease.

Official Title
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Open-Label Extension of Studies ATH-1017-AD-0201 and ATH-1017-AD-0202 in Subjects With Mild to Moderate Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Drug: ATH-1017


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Open label extension
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage | Drug: ATH-1017<br>* Daily subcutaneous (SC) injection of ATH-1017 in a pre-filled syringe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Description - To determine the safety and tolerability of ATH-1017 over an additional 130-week period in subjects with mild to moderate Alzheimer's disease (AD) who completed the 26-week randomized treatment in Study ATH-1017-AD-0201 or Study ATH-1017-AD-0202 | 130 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's, Dementia, ATH-1017, Open Label