Adults 40 to 85, any sex, with Parkinson Disease Dementia or Dementia With Lewy Bodies. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Global Statistical Test (GST) Score at BaselinePrimary· Baseline
The Global Statistical Test (GST) score is a composite of the change from baseline (CFB) z-scores to Week 26 in the Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13-Item Version (ADAS-Cog13; range 0-85; higher scores indicate greater impairment) and Event Related Potential P300 Latency (ERP P300; longer latency (milliseconds) indicates greater impairment). This composite approach was used to assess overall change in disease status and treatment effects of ATH-1017.
The GST score was defined as a single outcome variable based on standardizing and combining individual patient-level
Group
Value
95% CI
Placebo
-0.222
± 0.6365
ATH-1017 40 mg
0.332
± 0.6337
ATH-1017 70 mg
-0.036
± 1.0050
Event-related Potential (ERP) P300 Latency at BaselineSecondary· Baseline
ERP P300 was a method of recording brain activity elicited by external stimuli, for example (e.g.), an oddball auditory stimulus, particularly of working memory access. The participant had to perform a task related to auditory stimuli in order to assess the P300 component (latency). The stimulus consisted of an oddball paradigm with 2 sound stimuli. Stimuli were presented through headphones and auditory stimulation for P300 was assessed in a recording lasting up to 10 minutes. It was calculated as the average across the pre-dose values at Baseline visit.
Group
Value
95% CI
Placebo
381.84
± 51.739
ATH-1017 40 Milligrams (mg)
373.19
± 18.669
ATH-1017 70 mg
367.84
± 45.635
Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at BaselineSecondary· Baseline
The Alzheimer's Disease Assessment Scale - Cognitive Subscale, 13-Item Version (ADAS-Cog13) is designed to measure cognitive symptom change. The test comprises 9 performance items and 4 clinician-rated items (total score ranging from 0 to 85). Higher scores indicate more severe cognitive impairment.
Group
Value
95% CI
Placebo
16.9
± 6.94
ATH-1017 40 Milligrams (mg)
29.7
± 10.03
ATH-1017 70 mg
23.8
± 11.49
Adverse events — posted to ClinicalTrials.gov
Time frame: Up to Week 30.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
5 peer-reviewed publications reference this trial (live from Europe PMC):
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by LeonaBio
Last refreshed: 4 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04831281.