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| Name | Class |
|---|---|
| Danish Reference Center for Prion Diseases, Rigshospitalet | UNKNOWN |
| Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet | UNKNOWN |
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This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dementia with Lewy Bodies (DLB) | Mild cognitive impairment (MCI) to moderate dementia with probable DLB No other severe neurological or psychiatric diseases. No alcohol or drug abuse. |
| |
| Alzheimers disease (AD) | MCI to moderate dementia with probable AD. No other severe neurological or psychiatric diseases. No alcohol or drug abuse. |
| |
| Healthy Controls (HC) | Young healthy controls under the age of 40. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real-time quaking-induced conversion (RT-QuIC) | Diagnostic Test | RT-QuIC measures the ability of alpha-synuclein (aSyn) to misfold other aSyn proteins and is an amplification technique. |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic accuracy of Real-time quaking-induced conversion | Specificity | 24 months |
| Diagnostic accuracy of Real-time quaking-induced conversion | Sensitivity | 24 months |
| Diagnostic accuracy of Real-time quaking-induced conversion | Area under the curb | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sense of smell | Test with Sniffin Sticks 16, Score 0- 16 points | 24 months |
| Dysautonomia | Unified Parkinsons Rating Scale part I 0-52 |
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Inclusion criteria for healthy controls (HC):
Exclusion criteria
Inclusion criteria for patients with Dementia with Lewy Bodies (DLB):
Exclusion criteria for patients with DLB:
Inclusion criteria for controls (patients with Alzheimer's disease (AD)):
Exclusion criteria for controls (patients with AD):
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Twenty-five patients with probable DLB or mild cognitive impairment with Lewy bodies (MCI-LB) and 25 patients with AD or MCI-AD controls will be included from the memory clinic.
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| Name | Affiliation | Role |
|---|---|---|
| Oskar McWilliam | Danish Dementia Research Centre, Rigshospitalet, Capital Region | Principal Investigator |
| Kristian S Frederiksen | Danish Dementia Research Centre, Rigshospitalet, Capital Region | Principal Investigator |
| Anja H Simmonsen | Danish Dementia Research Centre, Rigshospitalet, Capital Region | Principal Investigator |
| Steen G Hasselbalch | Danish Dementia Research Centre, Rigshospitalet, Capital Region | Principal Investigator |
| Gunhild Waldemar | Danish Dementia Research Centre, Rigshospitalet, Capital Region | Principal Investigator |
| Marie Brunn | Danish Dementia Research Centre, Rigshospitalet, Capital Region | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Danish Dementia Research Centre | Copenhagen | 2100 | Denmark |
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Cerebrospinal fluid, olfactory mucosa, saliva, skin, urine, feces and blood
| Cognitive test | Diagnostic Test | Minimal Mental State examination (MMSE), Montreal Cognitive Assessment (MoCA) |
|
| Motor examination | Diagnostic Test | Unified Parkinsons Rating Scale (UPDRS) |
|
| 24 months |
| Motor functions | Unified Parkinsons Rating Scale part III Score range: 0-132 | 24 months |
| Cognitive function | Montreal Cognitive Assesment (MoCA) Score range: 0-30 | 24 months |
| Cognitive function | Minimal Mental State Examination (MMSE) Score range: 0-30 | 24 months |
| ID | Term |
|---|---|
| D020961 | Lewy Body Disease |
| D000544 | Alzheimer Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D003704 | Dementia |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D003072 | Cognition Disorders |
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