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Acetylcholinesterase Inhibitor

ATH-1017 for Parkinson's Disease

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 week 2, 12, 20, and 26
Awards & highlights

Study Summary

This trial is studying fosgonimeton (ATH-1017) to see if it is safe and works in people with Parkinson's Disease Dementia or Dementia with Lewy Bodies.

Eligible Conditions
  • Parkinson's Disease
  • Dementia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 2, 12, 20, and 26
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 2, 12, 20, and 26 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall treatment effect of ATH-1017 as reflected by the Global Statistical Test
Secondary outcome measures
Activities of Daily Living
Clinical Global Impression of Change
Cognition
+1 more
Other outcome measures
Motor Function

Side effects data

From 2022 Phase 2 trial • 77 Patients • NCT04491006
63%
Injection site reaction
22%
Eosinophilia
15%
Pruritus
15%
Headache
15%
Injection site vesicles
15%
Fatigue
11%
Injection site pain
11%
Arthralgia
11%
Paraesthesia
7%
Neutrophilia
7%
Injection site erythema
7%
Lipohypertrophy
7%
Fall
7%
Dizziness
7%
Contusion
7%
Post procedural complication
7%
Pollakiuria
4%
Injection site induration
4%
Back pain
4%
Skin exfoliation
4%
Hyperlipidaemia
4%
Application site pruritus
4%
Genital paraesthesia
4%
Injection site pruritus
4%
Induration
4%
Dementia Alzheimer's type
4%
Injection site paraesthesia
4%
Immediate post-injection reaction
4%
Syncope
4%
Vomiting
4%
Rash pruritic
4%
Agitation
4%
Anaemia
4%
White blood cell count increased
4%
Urticaria
4%
Pruritus allergic
4%
Hypoglycaemia
4%
Electrocardiogram QT prolonged
4%
Hypotension
4%
Eosinophil count increased
4%
Amaurosis fugax
4%
Pneumonia aspiration
4%
Feeling abnormal
4%
Extensor plantar response
4%
Hip fracture
4%
Cholinergic syndrome
4%
Injection site mass
4%
Chest discomfort
4%
Flushing
4%
Parosmia
4%
Thrombocytopenia
4%
Nausea
4%
Diarrhoea
4%
Toothache
4%
Abdominal pain upper
4%
Skin abrasion
4%
Joint injury
4%
Skin induration
4%
Disorientation
4%
Delirium
4%
Upper respiratory tract infection
4%
Vertigo
4%
Lung disorder
4%
Dysphemia
4%
Wound secretion
4%
Pain
4%
Hair colour changes
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: 70mg DoseExperimental Treatment1 Intervention
Daily subcutaneous injection of 70mg ATH-1017
Group II: 40mg DoseExperimental Treatment1 Intervention
Daily subcutaneous injection of 40mg ATH-1017
Group III: PlaceboPlacebo Group1 Intervention
Daily subcutaneous injection of Placebo
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
6 Previous Clinical Trials
1,213 Total Patients Enrolled

Frequently Asked Questions

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

Is this research project open to participants who are 45 years of age or older?

"This clinical trial requires participants to be between 40 and 85 years of age."

Answered by AI

Are there any available openings for participants in this medical trial?

"Affirmative, the data posted on clinicaltrials.gov reveals that this experiment is currently recruiting patients. This study was initially publicized on January 20th 2022 and recently modified on May 17th 2022. In total, 75 participants need to be sourced from 10 different trial sites."

Answered by AI

How much danger is posed by the use of ATH-1017?

"The safety rating of ATH-1017 is a 2, as it has only been tested in Phase 2 trials thus far. While data supports its level of security, there is yet to be any clinical evidence confirming efficacy."

Answered by AI

Who has the qualifications to join this clinical experiment?

"This medical study seeks to enrol 75 participants with Camurati-Engelmann Syndrome aged between 40 and 85."

Answered by AI

What is the participant count for this clinical investigation?

"Affirmative. The information found on clinicaltrials.gov illustrates that this medical experiment is recruiting individuals presently. This project was initially publicized on January 20th, 2022 and just recently updated on May 17th, 2022. Approximately 75 participants are needed across 10 different sites for the trial to be successful."

Answered by AI

How many sites are currently offering participation in this trial?

"This medical trial is being administered at 10 different facilities, including Decatur, Kirkland and West Palm Beach. To make the process more convenient for participants, it's wise to opt for the clinic closest to you."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)
2022. "ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04831281.
~9 spots leftby May 2025
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