Clinical trial NCT05768425: DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia
Official title: DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia - DISPLAY
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Dementia With Lewy Bodies
Alzheimer Disease
Mild Cognitive Impairment
Keywords: RT-QuIC
Dementia with Lewy bodies
CSF
Saliva
Olfactory mucosa
Urine
Feces
Blood
Skin
Lead sponsor: Danish Dementia Research Centre
Sponsor class: NETWORK
Collaborators: name: Danish Reference Center for Prion Diseases, Rigshospitalet
name: Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet
First posted: 2023-03-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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.

Primary outcomes:
measure: Diagnostic accuracy of Real-time quaking-induced conversion
timeFrame: 24 months
measure: Diagnostic accuracy of Real-time quaking-induced conversion
timeFrame: 24 months
measure: Diagnostic accuracy of Real-time quaking-induced conversion
timeFrame: 24 months
Secondary outcomes:
measure: Sense of smell
timeFrame: 24 months
measure: Dysautonomia
timeFrame: 24 months
measure: Motor functions
timeFrame: 24 months
measure: Cognitive function
timeFrame: 24 months
measure: Cognitive function
timeFrame: 24 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Danish Dementia Research Centre
Study officials:
affiliation: Danish Dementia Research Centre, Rigshospitalet, Capital Region
name: Oskar McWilliam
role: PRINCIPAL_INVESTIGATOR
affiliation: Danish Dementia Research Centre, Rigshospitalet, Capital Region
name: Kristian S Frederiksen
role: PRINCIPAL_INVESTIGATOR
affiliation: Danish Dementia Research Centre, Rigshospitalet, Capital Region
name: Anja H Simmonsen
role: PRINCIPAL_INVESTIGATOR
affiliation: Danish Dementia Research Centre, Rigshospitalet, Capital Region
name: Steen G Hasselbalch
role: PRINCIPAL_INVESTIGATOR
affiliation: Danish Dementia Research Centre, Rigshospitalet, Capital Region
name: Gunhild Waldemar
role: PRINCIPAL_INVESTIGATOR
affiliation: Danish Dementia Research Centre, Rigshospitalet, Capital Region
name: Marie Brunn
role: PRINCIPAL_INVESTIGATOR
References: