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

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
Are you not currently taking a medication called memantine (Namenda)?
Are you not currently participating in another clinical trial involving an investigational treatment?
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 26

Summary

This trial tests a new drug called fosgonimeton to see if it can help people with mild to moderate Alzheimer's disease think more clearly and perform daily activities better.

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

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You are not currently taking a drug called memantine (Namenda).
Select...
You are not currently enrolled in another study testing an experimental treatment.
Select...
Do you have someone who can help you take the trial drug (fosgonimeton or placebo) every day and stay with you during the trial?
Select...
You are not taking any medications like Aricept, Exelon or Namzaric that are classified as acetylcholinesterase inhibitors.
Select...
You must be between the ages of 55 and 85 to participate.
Select...
You have been diagnosed by a doctor with mild or moderate Alzheimer's disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 26 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
To evaluate the clinical efficacy of ATH1017 in subjects not on background acetylcholinesterase inhibitors (AChEIs)
Secondary study objectives
Activities of Daily Living
Cognition
To determine the effect of ATH1017 on plasma neurofilament light chain (NfL) concentration

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

2Treatment groups
Experimental Treatment
Placebo Group
Group I: DosageExperimental Treatment1 Intervention
Daily subcutaneous (SC) injection of 40mg ATH-1017
Group II: 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
736 Total Patients Enrolled

Media Library

ATH-1017 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04488419 — Phase 2 & 3
Alzheimer's Disease Research Study Groups: Dosage, Placebo
Alzheimer's Disease Clinical Trial 2023: ATH-1017 Highlights & Side Effects. Trial Name: NCT04488419 — Phase 2 & 3
ATH-1017 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04488419 — Phase 2 & 3
Alzheimer's Disease Patient Testimony for trial: Trial Name: NCT04488419 — Phase 2 & 3
~108 spots leftby Dec 2025
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