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

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Athira Pharma

Status and phase

Invitation-only
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 30 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

450 participants in 1 patient group

Treatment
Experimental group
Description:
Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage
Treatment:
Drug: ATH-1017

Trial contacts and locations

51

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Data sourced from clinicaltrials.gov

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