Dementia With Lewy BodiesDISPLAYNCT05768425
DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia
An observational study of Dementia With Lewy Bodies and Alzheimer Disease, run by Danish Dementia Research Centre at 1 site in Denmark.
Trial summary
This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dementia With Lewy Bodies, Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- Real-time quaking-induced conversion (RT-QuIC), Cognitive test and Motor examination
- How many people
- 55 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Feb 2023to Dec 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Age 18 - 40 years of age
- Able to cooperate as evaluated by the primary investigator (PI)
- Able to give informed consent
Who cannot join
- 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
Show all 22Show fewer
- Able to cooperate as evaluated by the PI
- MCI, mild or moderate dementia, and MMSE > 18
- 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
- Patients not able to give consent.
- Current alcohol or drug abuse
- Terminal illness
- Diagnosed with major neurological/psychiatric conditions other than AD.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia - DISPLAY
This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens.
Read the 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.
- Being tested
- Real-time quaking-induced conversion (RT-QuIC), Cognitive test, Motor examination
- Keywords
- RT-QuIC, Dementia with Lewy bodies, CSF, Saliva, Olfactory mucosa, Urine, Feces, Blood, Skin
- Medical subject headings
- Lewy Body Disease, Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Real-time quaking-induced conversion (RT-QuIC); Diagnostic Test: Cognitive test; Diagnostic Test: Motor examination | |
| Alzheimers disease (AD) | MCI to moderate dementia with probable AD. No other severe neurological or psychiatric diseases. No alcohol or drug abuse. Receives: Diagnostic Test: Real-time quaking-induced conversion (RT-QuIC); Diagnostic Test: Cognitive test; Diagnostic Test: Motor examination | |
| Healthy Controls (HC) | Young healthy controls under the age of 40. Receives: Diagnostic Test: Real-time quaking-induced conversion (RT-QuIC); Diagnostic Test: Cognitive test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of Real-time quaking-induced conversion
Specificity
Measured: 24 months
Diagnostic accuracy of Real-time quaking-induced conversion
Sensitivity
Measured: 24 months
Diagnostic accuracy of Real-time quaking-induced conversion
Area under the curb
Measured: 24 months
Secondary outcomes (5)
Sense of smell
Test with Sniffin Sticks 16, Score 0- 16 points
Measured: 24 months
Dysautonomia
Unified Parkinsons Rating Scale part I 0-52
Measured: 24 months
Motor functions
Unified Parkinsons Rating Scale part III Score range: 0-132
Measured: 24 months
Cognitive function
Montreal Cognitive Assesment (MoCA) Score range: 0-30
Measured: 24 months
Cognitive function
Minimal Mental State Examination (MMSE) Score range: 0-30
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start1 Feb 2023
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia With Lewy BodiesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Danish Dementia Research Centre
- Sponsor type
- Research network
- Collaborators
- Danish Reference Center for Prion Diseases, Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Oskar McWilliam, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Capital RegionKristian S Frederiksen, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Capital RegionAnja H Simmonsen, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Capital RegionSteen G Hasselbalch, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Capital RegionGunhild Waldemar, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Capital RegionMarie Brunn, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Capital Region
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768425
- Sponsor's protocol ID
- H-22046053
- Acronym
- DISPLAY
- Status last verified
- Oct 2023
- First submitted
- 13 Feb 2023
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia - DISPLAY
- ClinicalTrials.gov ID
- NCT05768425
- Acronym / sponsor ID
- DISPLAY / H-22046053
- Keywords
- RT-QuIC, Dementia with Lewy bodies, CSF, Saliva, Olfactory mucosa, Urine, Feces, Blood
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Danish Dementia Research CentreResearch network
- Collaborators
- Danish Reference Center for Prion Diseases, Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
- Study start
- 1 Feb 2023 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dementia with Lewy Bodies (DLB) | – | Diagnostic Test: Real-time quaking-induced conversion (RT-QuIC), Diagnostic Test: Cognitive test, Diagnostic Test: Motor examinationMild cognitive impairment (MCI) to moderate dementia with probable DLB No other severe neurological or psychiatric diseases. No alcohol or drug abuse. |
| Alzheimers disease (AD) | – | Diagnostic Test: Real-time quaking-induced conversion (RT-QuIC), Diagnostic Test: Cognitive test, Diagnostic Test: Motor examinationMCI to moderate dementia with probable AD. No other severe neurological or psychiatric diseases. No alcohol or drug abuse. |
| Healthy Controls (HC) | – | Diagnostic Test: Real-time quaking-induced conversion (RT-QuIC), Diagnostic Test: Cognitive testYoung healthy controls under the age of 40. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age 18 - 40 years of age
- Able to cooperate as evaluated by the primary investigator (PI)
- Able to give informed consent
Key exclusion criteria (22 listed)
- Signs of neurological/psychiatric conditions
- Known genetic neurodegenerative disease in close family
- Probable DLB (McKeith et al., 2017) or MCI-LB (McKeith et al., 2020)
- Age > 50 years of age
- Able to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Alzheimers disease (AD), Dementia with Lewy Bodies (DLB), Healthy Controls (HC) |
| Cognitive testMinimal Mental State examination (MMSE), Montreal Cognitive Assessment (MoCA) | Diagnostic test | Alzheimers disease (AD), Dementia with Lewy Bodies (DLB), Healthy Controls (HC) |
| Motor examinationUnified Parkinsons Rating Scale (UPDRS) | Diagnostic test | Alzheimers disease (AD), Dementia with Lewy Bodies (DLB) |
Primary outcome
Diagnostic accuracy of Real-time quaking-induced conversion
Time frame: 24 months
Specificity
Diagnostic accuracy of Real-time quaking-induced conversion
Time frame: 24 months
Sensitivity
Diagnostic accuracy of Real-time quaking-induced conversion
Time frame: 24 months
Area under the curb
5 secondary outcomes
Sense of smell
Time frame: 24 months
Dysautonomia
Time frame: 24 months
Motor functions
Time frame: 24 months
Cognitive function
Time frame: 24 months
Cognitive function
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oskar McWilliam principal investigator
Danish Dementia Research Centre, Rigshospitalet, Capital Region
Kristian S Frederiksen principal investigator
Danish Dementia Research Centre, Rigshospitalet, Capital Region
Anja H Simmonsen principal investigator
Danish Dementia Research Centre, Rigshospitalet, Capital Region
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia With Lewy Bodies and Alzheimer Disease, run by Danish Dementia Research Centre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of Real-time quaking-induced conversion (time frame: 24 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2023.