NCT05740683

Brief Summary

Test of early warning signs and RT-QuIC in patients with idiopathic olfactory dysfunction

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
80mo left

Started Feb 2023

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress33%
Feb 2023Dec 2032

Study Start

First participant enrolled

February 1, 2023

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

February 13, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2032

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2032

Last Updated

October 2, 2024

Status Verified

September 1, 2024

Enrollment Period

9.8 years

First QC Date

February 13, 2023

Last Update Submit

September 30, 2024

Conditions

Idiopathic AnosmiaIdiopathic HyposmiaIdiopathic Olfactory Dysfunction

Keywords

RT-QuICalpha-synucleinIdiopathic anosmiaIdiopathic hyposmiaIdiopathic olfactory dysfunctionProdromal Parkinsons diseaseProdromal dementia with Lewy bodies

Outcome Measures

Primary Outcomes (2)

  • Real-time quaking-induced conversion (RT-QuIC) positive for alpha-synuclein (aSyn)

    24 months

  • Diagnosis of Parkinson's disease (PD) or dementia

    A diagnosis of PD or dementia in national databases.

    8 years

Secondary Outcomes (10)

  • Smell test

    24 months

  • Smell test

    24 months

  • Motor function

    24 months

  • Dysautonomia and non-motor symptoms

    24 months

  • Subjective motor symptoms

    24 months

  • +5 more secondary outcomes

Study Arms (2)

People with idiopathic olfactory dysfunction

Diagnostic Test: RT-QuiC

People without olfactory dysfunction

Diagnostic Test: RT-QuiC

Interventions

RT-QuiCDIAGNOSTIC_TEST

RT-QuIC measures the ability of aSyn to misfold other aSyn proteins and is an amplification technique.

People with idiopathic olfactory dysfunctionPeople without olfactory dysfunction

Eligibility Criteria

Age55 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Fifty patients with idiopathic olfactory dysfunction (iOD) will be recruited from an anosmia clinic and community with posters in relevant newspapers and clinics. Also, 50 controls will be recruited from the community with posters in relevant newspapers and clinics.

You may qualify if:

  • Age 55 -75 years of age
  • Slowly progressing and non-fluctuating iOD
  • Able to give informed consent and to cooperate as evaluated by the PI

You may not qualify if:

  • Diagnosed with a neurodegenerative disease or major neurological/psychiatric condition.
  • Anosmia/hyposmia caused by sino-nasal disease (including chronic rhinitis and allergy), after trauma, infection, congenial, olfactory dysfunction due to surgery, or toxins/drugs affecting the olfactory function.
  • Olfactory dysfunction with response to systemic or local corticosteroids if tried
  • Severe nasal cavity abnormalities or infections.
  • Overt signs of dementia or PD
  • Current alcohol or drug abuse
  • Terminal illness
  • Diagnosed with neurodegenerative disease or major neurological/psychiatric condition.
  • Age 55 -75 years of age
  • Able to give informed consent
  • Able to cooperate as evaluated by the PI
  • Olfactory dysfunction on clinical test
  • Overt signs of dementia or PD
  • Severe nasal cavity abnormalities or infections.
  • Current alcohol or drug abuse
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Danish Dementia Research Centre

Copenhagen, 2100, Denmark

RECRUITING

Oskar McWilliam

Copenhagen, 2100, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Olfactory mucosa, skin, saliva and blood

MeSH Terms

Conditions

Parkinson Disease 4, Autosomal Dominant Lewy Body

Study Officials

  • Kristian S Frederiksen

    Danish Dementia Research Centre, Rigshospitalet, Capital Region

    PRINCIPAL INVESTIGATOR

  • Oskar McWilliam

    Danish Dementia Research Centre, Rigshospitalet, Capital Region

    PRINCIPAL INVESTIGATOR

  • Steen G Hasselbalch

    Danish Dementia Research Centre, Rigshospitalet, Capital Region

    PRINCIPAL INVESTIGATOR

  • Gunhild Waldemar

    Danish Dementia Research Centre, Rigshospitalet, Capital Region

    PRINCIPAL INVESTIGATOR

  • Marie Brunn

    Danish Dementia Research Centre, Rigshospitalet, Capital Region

    PRINCIPAL INVESTIGATOR

  • Anja H Simmonsen

    Danish Dementia Research Centre, Rigshospitalet, Capital Region

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Oskar McWilliam

CONTACT

+4535458759oskar.mcwilliam@regionh.dk

Kristian S Frederiksen

CONTACT

Kristian.Steen.Frederiksen@regionh.dk

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2023

First Posted

February 23, 2023

Study Start

February 1, 2023

Primary Completion (Estimated)

December 1, 2032

Study Completion (Estimated)

December 1, 2032

Last Updated

October 2, 2024

Record last verified: 2024-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)