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

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ClinicalTrials.gov Identifier: NCT05768425
Recruitment Status : Recruiting
First Posted : March 14, 2023
Last Update Posted : March 14, 2023
Sponsor:
Collaborators:
Danish Reference Center for Prion Diseases, Rigshospitalet
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
Information provided by (Responsible Party):
Danish Dementia Research Centre

Study Description
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Brief Summary:
This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens.

Condition or disease Intervention/treatment
Dementia With Lewy Bodies Alzheimer Disease Mild Cognitive Impairment Diagnostic Test: Real-time quaking-induced conversion (RT-QuIC) Diagnostic Test: Cognitive test Diagnostic Test: Motor examination

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 Design
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Study Type : Observational
Estimated Enrollment : 55 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia - DISPLAY
Actual Study Start Date : February 1, 2023
Estimated Primary Completion Date : December 2032
Estimated Study Completion Date : December 2032

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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.
 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)
Alzheimers disease (AD)
MCI to moderate dementia with probable AD. No other severe neurological or psychiatric diseases. No alcohol or drug abuse.
 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)
Healthy Controls (HC)
Young healthy controls under the age of 40.
 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)


Outcome Measures
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Primary Outcome Measures :
  1. Diagnostic accuracy of Real-time quaking-induced conversion [ Time Frame: 24 months ]
    Specificity

  2. Diagnostic accuracy of Real-time quaking-induced conversion [ Time Frame: 24 months ]
    Sensitivity

  3. Diagnostic accuracy of Real-time quaking-induced conversion [ Time Frame: 24 months ]
    Area under the curb


Secondary Outcome Measures :
  1. Sense of smell [ Time Frame: 24 months ]
    Test with Sniffin Sticks 16, Score 0- 16 points

  2. Dysautonomia [ Time Frame: 24 months ]
    Unified Parkinsons Rating Scale part I 0-52

  3. Motor functions [ Time Frame: 24 months ]
    Unified Parkinsons Rating Scale part III Score range: 0-132

  4. Cognitive function [ Time Frame: 24 months ]
    Montreal Cognitive Assesment (MoCA) Score range: 0-30

  5. Cognitive function [ Time Frame: 24 months ]
    Minimal Mental State Examination (MMSE) Score range: 0-30


Biospecimen Retention:   Samples Without DNA
Cerebrospinal fluid, olfactory mucosa, saliva, skin, urine, feces and blood

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Twenty-five patients with probable DLB or mild cognitive impairment with Lewy bodies (MCI-LB) and 25 patients with AD or MCI-AD controls will be included from the memory clinic.
Criteria

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.
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05768425


Contacts
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Contact: Oskar McWilliam +4535 45 87 59 oskar.mcwilliam@regionh.dk
Contact: Kristian S Frederiksen +4535456922 Kristian.Steen.Frederiksen@regionh.dk

Locations
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Denmark
Danish Dementia Research Centre Recruiting
Copenhagen, Denmark, 2100
Contact: Kristian Steen Frederiksen, MD, PhD    +4535456922    kristian.steen.frederiksen@regionh.dk   
Contact: Steen Gregers Hasselbalch, DMSc    +45 35 45 69 22    steen.gregers.hasselbalch@regionh.dk   
Sponsors and Collaborators
Danish Dementia Research Centre
Danish Reference Center for Prion Diseases, Rigshospitalet
Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
Investigators
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Principal Investigator: Oskar McWilliam Danish Dementia Research Centre, Rigshospitalet, Capital Region
Principal Investigator: Kristian S Frederiksen Danish Dementia Research Centre, Rigshospitalet, Capital Region
Principal Investigator: Anja H Simmonsen Danish Dementia Research Centre, Rigshospitalet, Capital Region
Principal Investigator: Steen G Hasselbalch Danish Dementia Research Centre, Rigshospitalet, Capital Region
Principal Investigator: Gunhild Waldemar Danish Dementia Research Centre, Rigshospitalet, Capital Region
Principal Investigator: Marie Brunn Danish Dementia Research Centre, Rigshospitalet, Capital Region
More Information
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Responsible Party: Danish Dementia Research Centre
ClinicalTrials.gov Identifier: NCT05768425    
Other Study ID Numbers: H-22046053
First Posted: March 14, 2023    Key Record Dates
Last Update Posted: March 14, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Danish Dementia Research Centre:
RT-QuIC
Dementia with Lewy bodies
CSF
Saliva
Olfactory mucosa
 Urine
Feces
Blood
Skin
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Lewy Body Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Synucleinopathies