Dementia With Lewy Bodies, Alzheimer Disease, Mild Cognitive Impairment
Conditions
Keywords
RT-QuIC, Dementia with Lewy bodies, CSF, Saliva, Olfactory mucosa, Urine, Feces, Blood, Skin
Brief summary
This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens.
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. A novel technique for the measurement of misfolded alpha-synuclein (aSyn) is Real-Time Quaking-Induced Conversion (RT-QuIC), which may be able to support the diagnostic process. Objective: Determining which biospecimen alone or in conjunction with other biospecimens can most accurately discriminate patients with DLB from Alzheimer's disease (AD) assessed by RT-QuIC for aSyn. Design: Cross-sectional case-control study of the diagnostic accuracy of pathological alpha-synuclein assessed by RT-QuIC in different biospecimens (CSF, skin, olfactory mucosa, saliva, feces, and urine) from patients with DLB versus AD. Patients will also be scored with tests for cognitive function, dysautonomia, and movement disorders.
Interventions
DIAGNOSTIC_TESTReal-time quaking-induced conversion (RT-QuIC)
RT-QuIC measures the ability of alpha-synuclein (aSyn) to misfold other aSyn proteins and is an amplification technique.
DIAGNOSTIC_TESTCognitive test
Minimal Mental State examination (MMSE), Montreal Cognitive Assessment (MoCA)
DIAGNOSTIC_TESTMotor examination
Unified Parkinsons Rating Scale (UPDRS)
Sponsors
Danish Reference Center for Prion Diseases, Rigshospitalet
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
Danish Dementia Research Centre
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
for healthy controls (HC): * Age 18 - 40 years of age * Able to cooperate as evaluated by the primary investigator (PI) * Able to give informed consent
Exclusion criteria
* Signs of neurological/psychiatric conditions * Known genetic neurodegenerative disease in close family Inclusion criteria for patients with Dementia with Lewy Bodies (DLB): * Probable DLB (McKeith et al., 2017) or MCI-LB (McKeith et al., 2020) * Age \> 50 years of age * Able to give informed consent * Able to cooperate as evaluated by the PI * MCI, mild or moderate dementia, and MMSE \> 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic accuracy of Real-time quaking-induced conversion | 24 months | Specificity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Sense of smell | 24 months | Test with Sniffin Sticks 16, Score 0- 16 points |
| Dysautonomia | 24 months | Unified Parkinsons Rating Scale part I 0-52 |
| Motor functions | 24 months | Unified Parkinsons Rating Scale part III Score range: 0-132 |
| Cognitive function | 24 months | Montreal Cognitive Assesment (MoCA) Score range: 0-30 |
Countries
Denmark
Outcome results
None listed