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Clinical Trial Summary

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


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT05740683
Study type Observational
Source Danish Dementia Research Centre
Contact Oskar McWilliam
Phone +4535458759
Email oskar.mcwilliam@regionh.dk
Status Recruiting
Phase
Start date February 1, 2023
Completion date December 2032

See also
  Status Clinical Trial Phase
Completed NCT04705805 - Self-assessment of Olfactory Disorders for French Speaking Patients