NCT05768425

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 55 (estimated)
• Sponsor: Danish Dementia Research Centre · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dementia With Lewy Bodies
• Alzheimer Disease
• Mild Cognitive Impairment

Interventions

Type	Name	Description
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.
DIAGNOSTIC_TEST	Cognitive test	Minimal Mental State examination (MMSE), Montreal Cognitive Assessment (MoCA)
DIAGNOSTIC_TEST	Motor examination	Unified Parkinsons Rating Scale (UPDRS)

Timeline

• Start date: 2023-02-01
• Primary completion: 2032-12-01
• Completion: 2032-12-01
• First posted: 2023-03-14
• Last updated: 2023-10-10

Locations

1 site across 1 country: Denmark