En studie av NE3107 i tidlig Parkinson (SUNRISE-PD)
7. august 2026 oppdatert av: BioVie Inc.
En dobbeltblind, randomisert, placebokontrollert studie av NE3107 hos personer med tidlig Parkinsons sykdom
Målet med denne kliniske studien er å finne ut om bezisterim kan behandle bevegelsessymptomer på Parkinsons sykdom hos pasienter som er 45 til 80 år gamle, med generelt god fysisk og mental helse, og som nærmer seg behov for behandling for å lindre symptomene, men som ikke har ennå blitt foreskrevet noen form for levodopa eller medikament med lignende aktivitet. Hovedspørsmålene den tar sikte på å besvare er:
- Vil bezisterim redusere bevegelsessymptomer på Parkinsons sykdom?
- Hvilke medisinske problemer har deltakerne når de tar bezisterim?
Forskere vil sammenligne effekten av bezisterim-behandling med placebo (et stoff som ligner på hverandre som ikke inneholder noe stoff) for å se om bezisterim fungerer for å behandle bevegelsessymptomer på Parkinsons sykdom.
Deltakerne vil
- ha en fysisk undersøkelse som inkluderer et elektrokardiogram
- ta medikament eller placebo to ganger daglig i fire måneder
- besøk et klinisk sted eller motta et hjemmebesøk syv ganger i løpet av fem måneder
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
57
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Michigan
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Farmington Hills, Michigan, Forente stater, 48334
- Quest Research Institute
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New York
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Amherst, New York, Forente stater, 14226
- Dent Neurologic
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North Carolina
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Morrisville, North Carolina, Forente stater, 27560
- Science 37 (Nationwide Site)
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Ohio
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Canton, Ohio, Forente stater, 44718
- Neuroscience Research Center, LLC
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inkluderingskriterier:
- 45 år til 80 år
- diagnostisert med idiopatisk Parkinsons sykdom (PD) innen 18 måneder
- nærmer seg behovet for symptomatisk behandling
- godta å bruke prevensjonstiltak
- gi frivillig samtykke
- villig til å tillate blodinnsamling for DNA-metyleringsanalyse
- bestå alle screeningtester og prosedyrer
Ekskluderingskriterier:
- har tatt levodopa eller et annet lignende legemiddel for de motoriske symptomene på PD
- en kjent eller sterkt mistenkt familiær årsak til PD-diagnose
- alvorlig psykisk helse eller fysisk sykdom
- medisinsk historie med alvorlig psykisk eller fysisk sykdom
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: NE3107
Forsøkspersonene vil motta 20 mg NE3107 BID (administrasjon to ganger daglig; 40 mg daglig) som orale kapsler.
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NE3107 20 mg BID
Andre navn:
|
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Placebo komparator: Placebo
Forsøkspersonene vil motta matchende placebokapsler for oral administrering BID (to ganger daglig).
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Placebo BID
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Monocyte Lymphocyte Ratio (MLR)
Tidsramme: 12 Weeks
|
A unitless inflammatory biomarker calculated by dividing the absolute peripheral blood monocyte count by the absolute peripheral blood lymphocyte count, using values derived from clinical hematology (complete blood count with differential)
|
12 Weeks
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Systemic Inflammation Response Index (SIRI)
Tidsramme: 12 weeks
|
A unitless measure of systemic inflammation calculated as the product of the absolute blood neutrophil count and absolute blood monocyte count divided by the absolute blood lymphocyte count in samples obtained for clinical hematology testing.
|
12 weeks
|
|
Change in Neutrophil-to-Lymphocyte Ratio (NLR)
Tidsramme: 12 weeks
|
A unitless measure of systemic inflammation calculated as the ratio of the absolute peripheral blood neutrophil count to the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
|
12 weeks
|
|
Change in Systemic Immune-Inflammation Index (SII)
Tidsramme: 12 weeks
|
A unitless composite measure of systemic inflammation and immune status calculated as the product of the absolute peripheral blood platelet count and neutrophil count divided by the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
|
12 weeks
|
|
Change in Platelet-to-Lymphocyte Ratio (PLR)
Tidsramme: 12 weeks
|
A unitless measure of systemic inflammation calculated as the ratio of the absolute peripheral blood platelet count to the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
|
12 weeks
|
|
Change in Aggregate Index of Systemic Inflammation (AISI)
Tidsramme: 12 weeks
|
A unitless composite measure of systemic inflammation calculated as the product of the absolute peripheral blood neutrophil count, monocyte count, and platelet count divided by the absolute peripheral blood lymphocyte count obtained from routine clinical hematology assessments.
|
12 weeks
|
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Change in the Composite Benefit Score (CBS)
Tidsramme: 12 weeks
|
Early Parkinson's Neuro-Inflammatory Composite-15 (EPNIC-15), a composite endpoint consisting of 15 clinically relevant motor and non-motor measures derived from MDS-UPDRS Parts I, II, and III and PDSS-2 assessments.
Lower scores indicate improvement in Parkinson's disease symptoms.
|
12 weeks
|
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Change in MDS-UPDRS modified Part III
Tidsramme: 12 weeks
|
Change from baseline in MDS-UPDRS Modified Part III score, a clinician-rated measure of Parkinson's disease motor signs assessed using a modified Part III examination.
The scale evaluates motor manifestations including speech, tremor, rigidity, bradykinesia, gait, posture, and postural stability.
Higher scores indicate worse motor impairment.
|
12 weeks
|
|
Change in MDS-UPDRS Part II scores
Tidsramme: 12 weeks
|
Change from baseline in MDS-UPDRS Part II score.
MDS-UPDRS Part II assesses the impact of Parkinson's disease motor symptoms on activities of daily living, with higher scores indicating greater impairment and negative changes indicating improvement.
|
12 weeks
|
|
Change in MDS-UPDRS Part I scores
Tidsramme: 12 weeks
|
Change from baseline in MDS-UPDRS Part I score.
MDS-UPDRS Part I assesses non-motor experiences of daily living in Parkinson's disease, with higher scores indicating greater symptom burden and negative changes indicating improvement.
|
12 weeks
|
|
Change in MDS-UPDRS combined scores
Tidsramme: 12 weeks
|
Change from baseline in the combined MDS-UPDRS score (Parts I + II + III).
The combined score assesses overall Parkinson's disease burden across non-motor symptoms, activities of daily living, and motor signs, with higher scores indicating greater impairment and negative changes indicating improvement.
|
12 weeks
|
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Change in PDQ-39 score
Tidsramme: 12 weeks
|
Change from baseline in PDQ-39 total score.
The Parkinson's Disease Questionnaire-39 (PDQ-39) assesses health-related quality of life across eight domains affected by Parkinson's disease.
Higher scores indicate worse quality of life and negative changes indicate improvement.
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12 weeks
|
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Clinician's General Impression of Improvement (CGI-I)
Tidsramme: 12 weeks
|
Clinician's Global Impression of Improvement (CGI-I) score.
The CGI-I is a clinician-rated measure of overall change in a participant's condition compared with baseline, scored on a 7-point scale from 1 (very much improved) to 7 (very much worse).
Lower scores indicate greater improvement.
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12 weeks
|
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Clinician's General Impression of Severity (CGI-S)
Tidsramme: 12 weeks
|
Change from baseline in Clinician's Global Impression of Severity (CGI-S) score.
The CGI-S is a clinician-rated measure of overall illness severity scored on a 7-point scale from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Higher scores indicate greater severity and negative changes indicate improvement.
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12 weeks
|
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Change in PARCOMS-Motor (modified to adjust for missing MDS-UPDRS Part III scores)
Tidsramme: 12 weeks
|
Change from baseline in modified PARCOMS-Motor score.
PARCOMS-Motor is a composite measure of Parkinson's disease motor symptoms derived from MDS-UPDRS motor assessments.
The score was modified to adjust for missing MDS-UPDRS Part III data.
Higher scores indicate greater motor impairment and negative changes indicate improvement
|
12 weeks
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in PDSS-2
Tidsramme: 12 weeks
|
Change from baseline in PDSS-2 total score.
The Parkinson's Disease Sleep Scale-2 (PDSS-2) assesses sleep disturbances and nocturnal symptoms associated with Parkinson's disease.
Higher scores indicate worse sleep impairment and negative changes indicate improvement.
|
12 weeks
|
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Change in DNA methylation
Tidsramme: 12 weeks
|
Change from baseline in DNA methylation levels measured in peripheral blood samples.
DNA methylation is an epigenetic biomarker associated with regulation of gene expression and cellular function.
|
12 weeks
|
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Percent change in hematologic inflammatory biomarker indices
Tidsramme: 12 weeks
|
Percent change from baseline in hematologic inflammatory biomarker indices (MLR, NLR, PLR, SIRI, SII, and AISI) derived from routine hematology testing.
These indices are calculated from peripheral blood cell counts and are used as measures of systemic inflammation.
|
12 weeks
|
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Change in plasma biomarkers of inflammation
Tidsramme: 12 week
|
Change from baseline in plasma biomarkers of inflammation measured in peripheral blood samples.
Plasma inflammatory biomarkers are indicators of immune and inflammatory activity that may reflect biological responses to treatment.
|
12 week
|
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Interaction between baseline inflammation level and treatment effect on changes in circulating inflammatory indices
Tidsramme: 12 weeks
|
Interaction between baseline inflammation level and treatment effect on changes in circulating inflammatory indices.
Analysis of whether treatment effects on MLR, NLR, PLR, SIRI, SII, and AISI vary according to baseline systemic inflammation status.
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12 weeks
|
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Interaction between baseline inflammation level and treatment effect on changes in clinical endpoints
Tidsramme: 12 weeks
|
Interaction between baseline inflammation level and treatment effect on changes in clinical endpoints.
Analysis of whether treatment effects on clinical measures vary according to baseline systemic inflammation status.
|
12 weeks
|
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Interaction between change in inflammation level and treatment effect on changes in circulating inflammatory indices
Tidsramme: 12 week
|
Relationship between change in inflammation level and change from baseline in circulating inflammatory indices (MLR, NLR, PLR, SIRI, SII, and AISI).
Analysis of whether treatment-related changes in systemic inflammation are associated with changes in circulating inflammatory biomarkers.
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12 week
|
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Interaction between change in inflammation level and treatment effect on changes in clinical endpoints
Tidsramme: 12 weeks
|
Relationship between change in inflammation level and change from baseline in clinical endpoints.
Analysis of whether treatment-related changes in systemic inflammation are associated with changes in clinical measures of Parkinson's disease.
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12 weeks
|
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Percent of subjects with any improvement from baseline as measured by CGI-I
Tidsramme: 12 weeks
|
Percent of participants with improvement on CGI-I.
Improvement is defined as a CGI-I score of 1 (very much improved), 2 (much improved), or 3 (minimally improved).
The CGI-I is a clinician-rated measure of overall change from baseline
|
12 weeks
|
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Percent of subjects with any improvement from baseline as measured by CGI-S
Tidsramme: 12 weeks
|
Percent of participants with improvement in CGI-S score from baseline.
Improvement is defined as any decrease from baseline in the Clinician's Global Impression of Severity (CGI-S) score.
The CGI-S is a clinician-rated measure of overall illness severity scored from 1 (normal, not at all ill) to 7 (among the most extremely ill patients).
Lower scores indicate less severe illness.
|
12 weeks
|
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Biological and disease phenotype subgroup analyses for changes in circulating inflammatory biomarker indices
Tidsramme: 12 weeks
|
Biological and disease phenotype subgroup analyses of changes in circulating inflammatory biomarker indices (MLR, NLR, PLR, SIRI, SII, and AISI).
Analyses will evaluate whether treatment-related changes in inflammatory biomarkers differ across predefined biological and disease phenotype subgroups.
|
12 weeks
|
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Biological and disease phenotype subgroup for changes in clinical endpoints
Tidsramme: 12 weeks
|
Biological and disease phenotype subgroup analyses of changes in clinical endpoints.
Analyses will evaluate whether treatment-related changes in clinical outcome measures differ across predefined biological and disease phenotype subgroups.
|
12 weeks
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Samarbeidspartnere og etterforskere
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Publikasjoner og nyttige lenker
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Hjelpsomme linker
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
26. mars 2025
Primær fullføring (Faktiske)
1. mai 2026
Studiet fullført (Faktiske)
31. mai 2026
Datoer for studieregistrering
Først innsendt
24. desember 2024
Først innsendt som oppfylte QC-kriteriene
2. januar 2025
Først lagt ut (Faktiske)
3. januar 2025
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
11. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NE3107-PD-202
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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