Idiopathic AnosmiaAROMANCT05740683
Alpha-synuclein Rt-quic and Neurologic Symptoms in Persons With idiOpathic anosMiA
An observational study of Idiopathic Anosmia and Idiopathic Hyposmia, run by Danish Dementia Research Centre at 2 sites in Denmark.
Trial summary
Test of early warning signs and RT-QuIC in patients with idiopathic olfactory dysfunction Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Idiopathic Anosmia, Idiopathic Hyposmia, Idiopathic Olfactory Dysfunction
- What is being tested?
- RT-QuiC
- How many people
- 100 participants
- Where
- 2 sitesDenmark
- Study dates
- 1 Feb 2023to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
- Age 55 -75 years of age
- Able to give informed consent
- Able to cooperate as evaluated by the PI
Who cannot join
- 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
Show all 13Show fewer
- Terminal illness
- Diagnosed with neurodegenerative disease or major neurological/psychiatric condition.
- Olfactory dysfunction on clinical test
- Overt signs of dementia or PD
- Severe nasal cavity abnormalities or infections.
- Current alcohol or drug abuse
- Diagnosed with neurodegenerative disease or major neurological/psychiatric condition.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kristian S Frederiksen contact
Denmark2 sites, 2 recruiting
- Recruiting
Danish Dementia Research Centre
Copenhagen, 2100
Kristian Steen Frederiksen, MD, PhD, +4535456922, kristian.steen.frederiksen@regionh.dk
Steen Gregers Hasselbalch, DMSc, +45 35 45 69 22, steen.gregers.hasselbalch@regionh.dk
- Recruiting
Oskar McWilliam
Copenhagen, 2100
Gunhild Waldemar, Gunhild.Waldemar.01@regionh.dk
About this study
Test of early warning signs and RT-QuIC in patients with idiopathic olfactory dysfunction
Read the detailed description
Background. The number of persons living with dementia is increasing in Denmark and worldwide because the population is generally growing older. Dementia with Lewy bodies (DLB) is the second most prevalent etiology among the neurodegenerative diseases that give rise to dementia.
DLB is characterized by many prodromal symptoms years before dementia is evident. Currently, little is known about the course of symptoms in the prodromal phase, and furthermore, the diagnosis of DLB can be clinically challenging, especially in the early stages. DLB is like Parkinson's disease (PD), characterized by the accumulation of alpha-synuclein, which misfolds and aggregates within neurons in so-called Lewy Bodies; this assumably drives the neurodegeneration. A novel technique for the measurement of misfolded alpha-synuclein is Real-Time Quaking-Induced Conversion (RT-QuIC), which may be able to support the diagnostic process as well as aid in identifying patients with prodromal DLB. This would enable earlier symptomatic relief and care and potentially promote the search for disease-modifying therapies, which is currently absent.
Objectives. The overarching objective of this project is to identify early clinical warning signs and biomarkers in prodromal DLB.
Method. Study 1: Exploratory cross-sectional case-control study of patients with olfactory dysfunction versus individuals without olfactory dysfunction assessing pathological alpha-synuclein by RT-QuIC and prodromal symptoms of DLB and Parkinson's Disease.
Study 2: Longitudinal follow-up in Danish registries on diagnosing PD and dementia.
- Being tested
- RT-QuiC
- Keywords
- RT-QuIC, alpha-synuclein, Idiopathic anosmia, Idiopathic hyposmia, Idiopathic olfactory dysfunction, Prodromal Parkinsons disease, Prodromal dementia with Lewy bodies
- Medical subject headings
- Parkinson Disease 4, Autosomal Dominant Lewy Body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RT-QuiCDiagnostic test
RT-QuIC measures the ability of aSyn to misfold other aSyn proteins and is an amplification technique.
| Study group | Role | What they receive |
|---|---|---|
| People with idiopathic olfactory dysfunction | Not described Receives: Diagnostic Test: RT-QuiC | |
| People without olfactory dysfunction | Not described Receives: Diagnostic Test: RT-QuiC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Real-time quaking-induced conversion (RT-QuIC) positive for alpha-synuclein (aSyn)
Measured: 24 months
Diagnosis of Parkinson's disease (PD) or dementia
A diagnosis of PD or dementia in national databases.
Measured: 8 years
Secondary outcomes (10)
Smell test
Sniffin Sticks identification test (SIT16)
Measured: 24 months
Smell test
Sniffin Sticks 48 (score 0-48)
Measured: 24 months
Motor function
Movement Disorder's Unified Parkinson's Rating Scale (MDS-UPDRS-III) (score 0-132)
Measured: 24 months
Dysautonomia and non-motor symptoms
Movement Disorder's Unified Parkinson's Rating Scale (MDS-UPDRS-I) (score 0-52)
Measured: 24 months
Subjective motor symptoms
Movement Disorder's Unified Parkinson's Rating Scale (MDS-UPDRS-II) (score 0-52)
Measured: 24 months
Cognition
MoCA, SDMT, Recall test and fluency (Animals/1 min)
Measured: 24 months
Prodromal PD
MDS Prodromal PD probability
Measured: 24 months
REM-sleep
REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) (score 0-13) and REM Sleep Behavior Disorder Single-Question Screen (RBD1Q)
Measured: Ever
Color vision
The Farnsworth-Munsell 100 Hue Color Vision test (score 0-1000)
Measured: Now
Co-morbidities and medication
Co-morbidities and medication
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2023
- Study start1 Feb 2023
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic AnosmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Dementia Research Centre
- Sponsor type
- Research network
- Collaborators
- Danish Reference Center for Prion Diseases, Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Kristian S Frederiksen, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Capital RegionOskar McWilliam, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Capital RegionSteen G Hasselbalch, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Capital RegionGunhild Waldemar, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Capital RegionMarie Brunn, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Capital RegionAnja H Simmonsen, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Capital Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05740683
- Sponsor's protocol ID
- H-22053428
- Acronym
- AROMA
- Status last verified
- Sep 2024
- First submitted
- 13 Feb 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alpha-synuclein Rt-quic and Neurologic Symptoms in Persons With idiOpathic anosMiA
- ClinicalTrials.gov ID
- NCT05740683
- Acronym / sponsor ID
- AROMA / H-22053428
- Keywords
- RT-QuIC, alpha-synuclein, Idiopathic anosmia, Idiopathic hyposmia, Idiopathic olfactory dysfunction, Prodromal Parkinsons disease, Prodromal dementia with Lewy bodies
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Danish Dementia Research CentreResearch network
- Collaborators
- Danish Reference Center for Prion Diseases, Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 23 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Test of early warning signs and RT-QuIC in patients with idiopathic olfactory dysfunction
Detailed description
Background. The number of persons living with dementia is increasing in Denmark and worldwide because the population is generally growing older. Dementia with Lewy bodies (DLB) is the second most prevalent etiology among the neurodegenerative diseases that give rise to dementia.
DLB is characterized by many prodromal symptoms years before dementia is evident. Currently, little is known about the course of symptoms in the prodromal phase, and furthermore, the diagnosis of DLB can be clinically challenging, especially in the early stages. DLB is like Parkinson's disease (PD), characterized by the accumulation of alpha-synuclein, which misfolds and aggregates within neurons in so-called Lewy Bodies; this assumably drives the neurodegeneration. A novel technique for the measurement of misfolded alpha-synuclein is Real-Time Quaking-Induced Conversion (RT-QuIC), which may be able to support the diagnostic process as well as aid in identifying patients with prodromal DLB. This would enable earlier symptomatic relief and care and potentially promote the search for disease-modifying therapies, which is currently absent.
Objectives. The overarching objective of this project is to identify early clinical warning signs and biomarkers in prodromal DLB.
Method. Study 1: Exploratory cross-sectional case-control study of patients with olfactory dysfunction versus individuals without olfactory dysfunction assessing pathological alpha-synuclein by RT-QuIC and prodromal symptoms of DLB and Parkinson's Disease.
Study 2: Longitudinal follow-up in Danish registries on diagnosing PD and dementia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| People with idiopathic olfactory dysfunction | – | Diagnostic Test: RT-QuiC |
| People without olfactory dysfunction | – | Diagnostic Test: RT-QuiC |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
- Age 55 -75 years of age
- Able to give informed consent
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RT-QuiCRT-QuIC measures the ability of aSyn to misfold other aSyn proteins and is an amplification technique. | Diagnostic test | People with idiopathic olfactory dysfunction, People without olfactory dysfunction |
Primary outcome
Real-time quaking-induced conversion (RT-QuIC) positive for alpha-synuclein (aSyn)
Time frame: 24 months
Diagnosis of Parkinson's disease (PD) or dementia
Time frame: 8 years
A diagnosis of PD or dementia in national databases.
10 secondary outcomes
Smell test
Time frame: 24 months
Smell test
Time frame: 24 months
Motor function
Time frame: 24 months
Dysautonomia and non-motor symptoms
Time frame: 24 months
Subjective motor symptoms
Time frame: 24 months
Cognition
Time frame: 24 months
Prodromal PD
Time frame: 24 months
REM-sleep
Time frame: Ever
Color vision
Time frame: Now
Co-morbidities and medication
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kristian S Frederiksen contact
Kristian S Frederiksen principal investigator
Danish Dementia Research Centre, Rigshospitalet, Capital Region
Oskar McWilliam principal investigator
Danish Dementia Research Centre, Rigshospitalet, Capital Region
Steen G Hasselbalch principal investigator
Danish Dementia Research Centre, Rigshospitalet, Capital Region
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Anosmia and Idiopathic Hyposmia, run by Danish Dementia Research Centre at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Oskar McWilliam (+4535458759, oskar.mcwilliam@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Real-time quaking-induced conversion (RT-QuIC) positive for alpha-synuclein (aSyn) (time frame: 24 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.