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ATH-1017 for Alzheimer's Disease (ACT-AD Trial)

Phase 2
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline (day 1)

Summary

This study is designed to evaluate treatment effects of ATH-1017 (fosgonimeton) in mild to moderate Alzheimer's subjects with a randomized treatment duration of 26-weeks.

Eligible Conditions
  • Alzheimer's Disease
  • Alzheimer's Dementia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline (day 1)
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline (day 1) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Event-related Potential (ERP) P300 Latency at Baseline
Secondary study objectives
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog11) at Baseline

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%
Skin exfoliation
4%
Rash pruritic
4%
Thrombocytopenia
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

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low DoseExperimental Treatment1 Intervention
Daily subcutaneous (SC) injection of Low Dose ATH-1017
Group II: High DoseExperimental Treatment1 Intervention
Daily subcutaneous (SC) injection of High Dose ATH-1017
Group III: PlaceboPlacebo Group1 Intervention
Daily subcutaneous (SC) injection of Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
ATH-1017
2020
Completed Phase 3
~530

Find a Location

Who is running the clinical trial?

Athira PharmaLead Sponsor
7 Previous Clinical Trials
1,217 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,790 Previous Clinical Trials
28,188,755 Total Patients Enrolled
~15 spots leftby Dec 2025
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