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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

55 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2032-12-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Dementia With Lewy Bodies Alzheimer Disease Mild Cognitive Impairment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.