NCT05740683

Alpha-synuclein Rt-quic and Neurologic Symptoms in Persons With idiOpathic anosMiA

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Danish Dementia Research Centre · Network
• Sex: All
• Age: 55 Years – 75 Years
• Healthy volunteers: —

Summary

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.

Conditions

• Idiopathic Anosmia
• Idiopathic Hyposmia
• Idiopathic Olfactory Dysfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	RT-QuiC	RT-QuIC measures the ability of aSyn to misfold other aSyn proteins and is an amplification technique.

Timeline

• Start date: 2023-02-01
• Primary completion: 2032-12-01
• Completion: 2032-12-01
• First posted: 2023-02-23
• Last updated: 2024-10-02

Locations

2 sites across 1 country: Denmark