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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05768425
Other study ID # H-22046053
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date February 1, 2023
Est. completion date December 2032

Study information

Verified date October 2023
Source Danish Dementia Research Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 55
Est. completion date December 2032
Est. primary completion date December 2032
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Exclusion criteria for patients with DLB: - Patients not able to give informed consent. - Current alcohol or drug abuse - Terminal illness - Diagnosed with major neurological/psychiatric conditions other than DLB. Inclusion criteria for controls (patients with Alzheimer's disease (AD)): - Probable AD (McKhann et al., 2011) or MCI-AD (Albert et al., 2011) - 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 Exclusion criteria for controls (patients with AD): - Patients not able to give consent. - Current alcohol or drug abuse - Terminal illness - Diagnosed with major neurological/psychiatric conditions other than AD.

Study Design


Intervention

Diagnostic Test:
Real-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.
Cognitive test
Minimal Mental State examination (MMSE), Montreal Cognitive Assessment (MoCA)
Motor examination
Unified Parkinsons Rating Scale (UPDRS)

Locations

Country Name City State
Denmark Danish Dementia Research Centre Copenhagen

Sponsors (3)

Lead Sponsor Collaborator
Danish Dementia Research Centre Danish Reference Center for Prion Diseases, Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy of Real-time quaking-induced conversion Specificity 24 months
Primary Diagnostic accuracy of Real-time quaking-induced conversion Sensitivity 24 months
Primary Diagnostic accuracy of Real-time quaking-induced conversion Area under the curb 24 months
Secondary Sense of smell Test with Sniffin Sticks 16, Score 0- 16 points 24 months
Secondary Dysautonomia Unified Parkinsons Rating Scale part I 0-52 24 months
Secondary Motor functions Unified Parkinsons Rating Scale part III Score range: 0-132 24 months
Secondary Cognitive function Montreal Cognitive Assesment (MoCA) Score range: 0-30 24 months
Secondary Cognitive function Minimal Mental State Examination (MMSE) Score range: 0-30 24 months
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