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

Active, not recruiting

• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Dementia With Lewy Bodies

• Registration Number: NCT05768425
• Lead Sponsor: Danish Dementia Research Centre

Brief 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.

Study Timeline

• Study Start: 2023-02-01
• Study First Submitted: 2023-02-13
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-14
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-09
• Last Update Posted: 2023-10-10
• Primary Completion: 2032-12
• Study Completion: 2032-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy of Real-time quaking-induced conversion	24 months	Area under the curb

Secondary Outcome Measures

Name	Time	Method
Sense of smell	24 months	Test with Sniffin Sticks 16, Score 0- 16 points
Cognitive function	24 months	Minimal Mental State Examination (MMSE) Score range: 0-30
Dysautonomia	24 months	Unified Parkinsons Rating Scale part I 0-52
Motor functions	24 months	Unified Parkinsons Rating Scale part III Score range: 0-132

Trial Locations

Locations (1)

Danish Dementia Research Centre; 🇩🇰 Copenhagen, Denmark