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Unknown

ATH-1017 for Alzheimer's Disease

Phase 2 & 3
Waitlist Available
Research Sponsored by Athira Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be older than 18 years old
Must not have
New diagnosis of severe major depressive disorder even without psychotic features
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 210 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing the safety and tolerability of fosgonimeton in Alzheimer's patients who have completed other studies.

Who is the study for?
This trial is for people with mild to moderate Alzheimer's who finished a previous 26-week study of ATH-1017. Participants need a reliable caregiver, must be in good health overall, and men must use contraception. It's not for those who had serious side effects before, have severe depression or psychosis, are at risk of suicide, or were recently diagnosed with cancer (except certain skin or prostate cancers).
What is being tested?
The trial tests the safety and tolerability of fosgonimeton (ATH-1017) in patients with mild to moderate Alzheimer's disease who completed prior studies on this drug. The goal is to see how well they handle the treatment over an extended period.
What are the potential side effects?
While specific side effects aren't listed here, generally the study aims to monitor any adverse reactions from long-term use of ATH-1017 in participants from earlier phases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am a male and will use double contraception during and after the study.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been newly diagnosed with severe depression without psychosis.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~210 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 210 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

Side effects data

From 2022 Phase 2 trial • 77 Patients • NCT04491006
63%
Injection site reaction
22%
Eosinophilia
15%
Injection site vesicles
15%
Fatigue
15%
Headache
15%
Pruritus
11%
Injection site pain
11%
Paraesthesia
11%
Arthralgia
7%
Injection site erythema
7%
Dizziness
7%
Neutrophilia
7%
Fall
7%
Contusion
7%
Post procedural complication
7%
Lipohypertrophy
7%
Pollakiuria
4%
Skin induration
4%
Rash pruritic
4%
Thrombocytopenia
4%
Skin exfoliation
4%
Vertigo
4%
Hip fracture
4%
Injection site induration
4%
Cholinergic syndrome
4%
Injection site paraesthesia
4%
Injection site pruritus
4%
Injection site mass
4%
Chest discomfort
4%
Pain
4%
Flushing
4%
Induration
4%
Immediate post-injection reaction
4%
Application site pruritus
4%
Feeling abnormal
4%
Extensor plantar response
4%
Dementia Alzheimer's type
4%
Syncope
4%
Parosmia
4%
Anaemia
4%
Nausea
4%
Vomiting
4%
Diarrhoea
4%
Toothache
4%
Abdominal pain upper
4%
Wound secretion
4%
Skin abrasion
4%
Joint injury
4%
Pruritus allergic
4%
Hair colour changes
4%
Urticaria
4%
Back pain
4%
Agitation
4%
Disorientation
4%
Delirium
4%
Dysphemia
4%
Electrocardiogram QT prolonged
4%
Eosinophil count increased
4%
White blood cell count increased
4%
Upper respiratory tract infection
4%
Hyperlipidaemia
4%
Hypoglycaemia
4%
Hypotension
4%
Amaurosis fugax
4%
Genital paraesthesia
4%
Pneumonia aspiration
4%
Lung disorder
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
ATH-1017 40 mg
ATH-1017 70 mg

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
Daily subcutaneous (SC) injection of ATH-1017 - 40mg Dosage
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATH-1017
2020
Completed Phase 2
~110

Find a Location

Who is running the clinical trial?

Athira PharmaLead Sponsor
7 Previous Clinical Trials
871 Total Patients Enrolled

Media Library

ATH-1017 (Unknown) Clinical Trial Eligibility Overview. Trial Name: NCT04886063 — Phase 2 & 3
Alzheimer's Disease Research Study Groups: Treatment
Alzheimer's Disease Clinical Trial 2023: ATH-1017 Highlights & Side Effects. Trial Name: NCT04886063 — Phase 2 & 3
ATH-1017 (Unknown) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04886063 — Phase 2 & 3
~233 spots leftby Aug 2028
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