ATH-1017 Treatment in Subjects With Parkinson's Disease Dementia or Dementia With Lewy Bodies (SHAPE Trial)

Summary

This study is designed to evaluate the safety and treatment effects of fosgonimeton (ATH-1017) in subjects with Parkinson's Disease Dementia or Dementia with Lewy Bodies, with a randomized treatment duration of 26 weeks.

Timeline

Start

2022-01-20

Primary completion

2023-04-19

Completion

2023-04-19

Outcome

Missed primary endpoint

Stopped (Enrollment): “Enrollment ended early due to study design limitations.”

release “primary endpoint of SHAPE, a composite score of the change in Event-Related-Potential (ERP) P300 latency and cognitive assessment (ADAS-Cog13), was not met compared with placebo.” leonabio.com ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	fosgonimeton	Small molecule	40 mg	Subcutaneous
Subject	fosgonimeton	Small molecule	70 mg	Subcutaneous

Indications