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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
Subject capable of giving signed informed consent, or by a legally acceptable representative
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 130 weeks
Awards & highlights

Study 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).Check my eligibility
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.See study design
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.
Select...
I can sign the consent form myself or have someone legally allowed to do it for me.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~130 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 130 weeks for reporting.

Treatment Details

Study Objectives

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

Side effects data

From 2022 Phase 2 trial • 77 Patients • NCT04491006
81%
Injection site reaction
19%
Eosinophilia
12%
Diarrhoea
12%
Injection site nodule
12%
Dizziness
8%
Headache
8%
Contusion
8%
Back pain
8%
Anaemia
8%
Fall
4%
Adverse drug reaction
4%
Dermatitis
4%
Pruritus
4%
Pain in extremity
4%
Tremor
4%
Vaccination complication
4%
Chest pain
4%
Sensory disturbance
4%
Paraesthesia
4%
Injection site vesicles
4%
Injection site induration
4%
Injection site pruritus
4%
Injection site oedema
4%
Injection site rash
4%
Fatigue
4%
Chest discomfort
4%
Hypersomnia
4%
Dysarthria
4%
Nausea
4%
Vomiting
4%
Colitis
4%
Enteritis
4%
Rib fracture
4%
Night sweats
4%
Polymyalgia rheumatica
4%
Muscle spasms
4%
Anxiety
4%
Confusional state
4%
Hallucination, visual
4%
Depressive symptom
4%
Blood creatinine increased
4%
Blood alkaline phosphatase increased
4%
Urinary tract infection
4%
Hyperlipidaemia
4%
Atrial fibrillation
4%
Vulvovaginal burning sensation
4%
Basal cell carcinoma
4%
Hiatus hernia
4%
Injection site bruising
4%
Injection site paraesthesia
4%
Agitation
4%
Blood glucose increased
4%
Liver function test abnormal
4%
Injection site pain
4%
Hallucination
100%
80%
60%
40%
20%
0%
Study treatment Arm
ATH-1017 70 mg
Placebo
ATH-1017 40 mg

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
~80

Find a Location

Who is running the clinical trial?

Athira PharmaLead Sponsor
6 Previous Clinical Trials
827 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are new participants being admitted to this research endeavor?

"The clinical trial posted on June 30th, 2021 is no longer accepting patients. The last update was made February 28th, 2022. However, over 500 other trials are actively recruiting participants currently."

Answered by AI

What potential risks do patients face when taking ATH-1017?

"The safety rating of ATH-1017 was assigned a 2, as the Phase 2 trial has provided data attesting to its security but no evidence proving efficacy."

Answered by AI

Does this clinical experiment accept participants aged 20 and above?

"As per the terms of this research program, applicants must be between 55 and 85 years old to qualify for inclusion."

Answered by AI

At what number of locations is this trial currently being conducted?

"In addition to the 3 sites previously mentioned, there are 28 other institutions offering this trial; some of these include Indiana University's Neuroscience Center and Mile High Research Center in Denver."

Answered by AI

Who meets the eligibility criteria to participate in this investigation?

"This research programme seeks 300 individuals with Alzheimer's disease aged between 55-85. Those that meet these criteria are eligible to apply for the clinical trial."

Answered by AI

Who else is applying?

What site did they apply to?
Neurobehavioral Clinical Research
What portion of applicants met pre-screening criteria?
Did not meet criteria
~225 spots leftby Jan 2027