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α-synuclein seeding-aktivitet i lukteslimhinnen i COVID-19

23. september 2026 oppdatert av: Medical University Innsbruck

α-synuclein seeding-aktivitet i lukteslimhinnen i COVID-19 - En pilotstudie

Loss of the sense of smell is a characteristic feature of COVID-19 and likely related to viral invasion of the olfactory mucosa but is also a prodromal feature of PD. This constellation has kindled concerns that COVID-19 - similar to the Spanish Flu Pandemic in 1918 - might trigger a second wave of post-infectious parkinsonism. The main objective of the study is to probe for the presence of pathological α-synuclein assemblies in the olfactory mucosa of patients with COVID-19.

Studieoversikt

Status

Fullført

Forhold

Detaljert beskrivelse

Deposits of misfolded proteins are the cause of frequent neurological diseases such as Alzheimer's or Parkinson's disease. In Parkinson's disease, the misfolded protein alpha-synuclein is found in the olfactory mucosa of the nose, which contains nerve cells responsible for smell perception, from which the misfolded alpha-synuclein spreads further into the brain. The mechanisms that lead to this misfolding and the resulting damage to the nervous system are still unclear. One hypothesis is that inflammatory processes such as viral infections trigger the misfolding of alpha-synuclein in Parkinson's disease and can lead to its deposition. Based on this assumption and the striking involvement of the sense of smell in SARS-CoV-2 infection (COVID-19), the aim of this study is to investigate the olfactory epithelium of the nasal mucosa of COVID-19 patients for possible alpha-synuclein deposits by using nasal swabs.

We hypothesize that the invasion of olfactory neurons and subsequent inflammatory responses could trigger α-synuclein misfolding and aggregation. Therefore, we aim to investigate for the presence of α-synuclein seeding activity in the olfactory mucosa of subjects who have recovered from COVID-19 by using Real-time Quaking-Induced Conversion (RT-QuIC).

Studietype

Observasjonsmessig

Registrering (Faktiske)

188

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Innsbruck, Østerrike
        • Medical University of Innsbruck

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Person living in the Tirol area

Beskrivelse

Inclusion Criteria:

  1. Participants must be 18 years or older;

  2. Participants are able to understand the aim of the study and the planned procedures;

  3. Written informed consent form;

  4. Participants fulfilling the criteria for one of the following groups:

    1. COVID-19 patients with OD:

      • Prior history of COVID-19 (clinical documentation plus corresponding positive PCR test) at least 3 months ago;
      • OD (Sniffin' sticks discrimination and identification both <13/16 items correct) persisting for at least 3 months after SARS-CoV-2 infection;
      • Negative antigen test on day of study inclusion;
      • No evidence of structural nasal pathologies possibly responsible for OD.
    2. COVID-19 patients without OD:

      • Prior history of COVID-19 (clinical documentation plus corresponding positive PCR test) at least 3 months ago;
      • No history of/current OD (Sniffin' sticks discrimination and identification both >12/16 items correct);
      • Negative antigen test on day of study inclusion.
    3. Healthy Controls:

      • No history of COVID-19 and negative SARS-CoV-2 antibody test unless subject is vaccinated;
      • Negative antigen test on day of study inclusion;
      • No history of OD;
      • Subjective and objective normal olfactory function (Sniffin' sticks discrimination and identification both >12/16 items correct). 10 Application for Clinical Research
    4. Patients with Parkinson's disease (n = 50):

      • Confirmed diagnosis of PD according to diagnostic criteria.
      • No history of COVID-19 and negative SARS-CoV-2 antibody test unless subject is vaccinated;
      • Negative antigen test on day of study inclusion;

Exclusion Criteria:

  1. Patients:

    • History of OD prior to SARS-CoV-2 infection;
    • Pre-existent relevant neurological disorder;
    • Positive SARS-CoV-2 antigen test on day of study inclusion;
    • Patients with OD only: structural pathology possibly responsible for OD.
  2. Healthy controls:

    • Pre-existent relevant neurological disorder;
    • History of/presence of olfactory dysfunction (Sniffin' sticks discrimination and identification both <13/16 items correct);
    • Positive SARS-CoV-2 antigen test on day of study inclusion;
    • Positive SARS-CoV-2 antibody test unless subject is vaccinated.
  3. Patients with Parkinson's disease:

    • History of COVID-19;
    • Positive SARS-CoV-2 antigen test on day of study inclusion;
    • Positive SARS-CoV-2 antibody test unless subject is vaccinated.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Observasjonsmodeller: CASE_CONTROL
  • Tidsperspektiver: PROSPECTIVE

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
COVID-19 patients with olfactory dysfunction

COVID-19 patients with olfactory dysfunction

RT-QuIC is increasingly used as diagnostic tools in synucleinopathies and has shown high sensitivity and specificity for the detection of α-synuclein seeds in CSF and tissue samples, including the olfactory mucosa in different patients' cohorts including Parkinson's patientients, patients with REM sleep behavior disorder (RBD), and patients with dementia with Lewy bodies.

COVID-19 patients without olfactory dysfunction

COVID-19 patients without olfactory dysfunction

RT-QuIC is increasingly used as diagnostic tools in synucleinopathies and has shown high sensitivity and specificity for the detection of α-synuclein seeds in CSF and tissue samples, including the olfactory mucosa in different patients' cohorts including Parkinson's patientients, patients with REM sleep behavior disorder (RBD), and patients with dementia with Lewy bodies.

Healthy controls

Healthy controls

RT-QuIC is increasingly used as diagnostic tools in synucleinopathies and has shown high sensitivity and specificity for the detection of α-synuclein seeds in CSF and tissue samples, including the olfactory mucosa in different patients' cohorts including Parkinson's patientients, patients with REM sleep behavior disorder (RBD), and patients with dementia with Lewy bodies.

Patients with Parkinson's disease

Patients with Parkinson's disease

RT-QuIC is increasingly used as diagnostic tools in synucleinopathies and has shown high sensitivity and specificity for the detection of α-synuclein seeds in CSF and tissue samples, including the olfactory mucosa in different patients' cohorts including Parkinson's patientients, patients with REM sleep behavior disorder (RBD), and patients with dementia with Lewy bodies.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Demonstration of ⍺-synuclein seeding activity in the OM (assessed by RT-QuIC) in subjects who recovered from COVID-19 compared to healthy controls.
Tidsramme: 2 years

detection ⍺-synuclein seeding activity in olfactory mucosa of different patient groups

2 years

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Beatrice Heim, MD PhD, Medical University Innsbruck

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)

11. august 2022

Primær fullføring (Faktiske)

31. desember 2024

Studiet fullført (Faktiske)

31. desember 2024

Datoer for studieregistrering

Først innsendt

1. juni 2022

Først innsendt som oppfylte QC-kriteriene

1. juni 2022

Først lagt ut (Faktiske)

2. juni 2022

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

28. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

23. september 2026

Sist bekreftet

1. april 2025

Mer informasjon

Begreper knyttet til denne studien

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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