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

Athira Pharma

Status and phase

Active, not recruiting

Phase 3

Phase 2

Conditions

Alzheimer Disease

Treatments

Drug: ATH-1017

Study type

Interventional

Funder types

Industry

Identifiers

NCT04886063

ATH-1017-AD-0203

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

450 estimated patients

Sex

All

Ages

55 to 85 years old

Volunteers

No Healthy Volunteers

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