Test of early warning signs and RT-QuIC in patients with idiopathic olfactory dysfunction
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 Type
OBSERVATIONAL
Enrollment
100
RT-QuIC measures the ability of aSyn to misfold other aSyn proteins and is an amplification technique.
Danish Dementia Research Centre
Copenhagen, Denmark
RECRUITINGOskar McWilliam
Copenhagen, Denmark
RECRUITINGReal-time quaking-induced conversion (RT-QuIC) positive for alpha-synuclein (aSyn)
Time frame: 24 months
Diagnosis of Parkinson's disease (PD) or dementia
A diagnosis of PD or dementia in national databases.
Time frame: 8 years
Smell test
Sniffin Sticks identification test (SIT16)
Time frame: 24 months
Smell test
Sniffin Sticks 48 (score 0-48)
Time frame: 24 months
Motor function
Movement Disorder's Unified Parkinson's Rating Scale (MDS-UPDRS-III) (score 0-132)
Time frame: 24 months
Dysautonomia and non-motor symptoms
Movement Disorder's Unified Parkinson's Rating Scale (MDS-UPDRS-I) (score 0-52)
Time frame: 24 months
Subjective motor symptoms
Movement Disorder's Unified Parkinson's Rating Scale (MDS-UPDRS-II) (score 0-52)
Time frame: 24 months
Cognition
MoCA, SDMT, Recall test and fluency (Animals/1 min)
Time frame: 24 months
Prodromal PD
MDS Prodromal PD probability
Time frame: 24 months
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REM-sleep
REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ) (score 0-13) and REM Sleep Behavior Disorder Single-Question Screen (RBD1Q)
Time frame: Ever
Color vision
The Farnsworth-Munsell 100 Hue Color Vision test (score 0-1000)
Time frame: Now
Co-morbidities and medication
Co-morbidities and medication
Time frame: 10 years