Actively Recruiting
Alpha-synuclein RT-QuIC and Neurologic Symptoms in Persons With Idiopathic Anosmia
Led by Danish Dementia Research Centre · Updated on 2024-10-02
100
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
D
Danish Dementia Research Centre
Lead Sponsor
D
Danish Reference Center for Prion Diseases, Rigshospitalet
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating early warning signs and biomarkers for dementia with Lewy bodies (DLB), a common cause of dementia linked to the buildup of misfolded alpha-synuclein protein in the brain. The study focuses on people with idiopathic olfactory dysfunction—loss or reduction of smell without known cause—to better understand symptom progression and improve early diagnosis, potentially aiding future treatments. Participants include people with and without olfactory dysfunction. The study uses Real-Time Quaking-Induced Conversion (RT-QuIC), a laboratory technique that detects misfolded alpha-synuclein, to assess samples from participants. It involves an exploratory cross-sectional case-control design and a long-term follow-up using Danish health registries to track diagnoses of Parkinson's disease or dementia. During the study, participants undergo smell tests, motor function exams, cognitive assessments, and evaluations of other symptoms related to Parkinson's disease and DLB at regular intervals over 24 months and longer. Researchers monitor the presence of misfolded alpha-synuclein and track diagnoses over up to 8 years. This observational study helps identify early signs and disease progression markers while participants continue their usual care.
CONDITIONS
Brief Title
Alpha-synuclein Rt-quic and Neurologic Symptoms in Persons With idiOpathic anosMiA
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 55 to 75 years
- Slowly progressing and non-fluctuating idiopathic olfactory dysfunction
- Able to give informed consent and cooperate as evaluated by the principal investigator
- Control participants aged 55 to 75 years
- Control participants able to give informed consent and cooperate as evaluated by the principal investigator
You will not qualify if you...
- Diagnosed with neurodegenerative disease or major neurological/psychiatric condition
- Anosmia or hyposmia caused by sino-nasal disease, trauma, infection, congenital conditions, surgery, toxins, or drugs affecting smell
- Olfactory dysfunction responsive to corticosteroids if tried
- Severe nasal cavity abnormalities or infections
- Overt signs of dementia or Parkinson's disease
- Current alcohol or drug abuse
- Terminal illness
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 months
Participants undergo testing including the RT-QuIC diagnostic test to measure alpha-synuclein misfolding and other assessments related to olfactory function and neurologic symptoms.
Multiple visits over 24 months for assessments including smell tests, motor function, cognition, and symptom tracking
Duration - Up to 8 to 10 years
Participants are followed longitudinally through Danish registries to monitor diagnoses of Parkinson's disease, dementia, and other related health outcomes.
Observational follow-up via registry data with no required visits
Trial Site Locations
Total: 2 locations
1
Danish Dementia Research Centre
Copenhagen, Denmark, 2100
Actively Recruiting
2
Oskar McWilliam
Copenhagen, Denmark, 2100
Actively Recruiting
Research Team
O
Oskar McWilliam
K
Kristian S Frederiksen
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Frequently Asked Questions
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