DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia

N/AActive Not RecruitingNCT05768425

Danish Dementia Research Centre55 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Dementia With Lewy Bodies Alzheimer Disease Mild Cognitive Impairment

Interventions

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.

Cognitive testDIAGNOSTIC_TEST

Minimal Mental State examination (MMSE), Montreal Cognitive Assessment (MoCA)

Motor examinationDIAGNOSTIC_TEST

Unified Parkinsons Rating Scale (UPDRS)

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Danish Dementia Research Centre

Copenhagen, Denmark

Outcomes

Primary Outcomes

Diagnostic accuracy of Real-time quaking-induced conversion

Specificity

Time frame: 24 months

Diagnostic accuracy of Real-time quaking-induced conversion

Sensitivity

Time frame: 24 months

Diagnostic accuracy of Real-time quaking-induced conversion

Area under the curb

Time frame: 24 months

Secondary Outcomes

Sense of smell

Test with Sniffin Sticks 16, Score 0- 16 points

Time frame: 24 months

Dysautonomia

Unified Parkinsons Rating Scale part I 0-52

Time frame: 24 months

Motor functions

Unified Parkinsons Rating Scale part III Score range: 0-132

Time frame: 24 months

Cognitive function

Montreal Cognitive Assesment (MoCA) Score range: 0-30

Time frame: 24 months

Cognitive function

Minimal Mental State Examination (MMSE) Score range: 0-30

Time frame: 24 months

Data from ClinicalTrials.gov

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