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

NCT05768425 | Active Not Recruiting

• 1 other identifier: H-22046053
• Study Type: observational
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens.

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

Outcome Measures

Primary Outcomes (3)

• Diagnostic accuracy of Real-time quaking-induced conversion

  Specificity

  24 months

• Diagnostic accuracy of Real-time quaking-induced conversion

  Sensitivity

  24 months

• Diagnostic accuracy of Real-time quaking-induced conversion

  Area under the curb

  24 months

Secondary Outcomes (5)

• Sense of smell

  24 months

• Dysautonomia

  24 months

• Motor functions

  24 months

• Cognitive function

  24 months

• Cognitive function

  24 months

Study Arms (3)

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); 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.

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.

Diagnostic Test: Real-time quaking-induced conversion (RT-QuIC); Diagnostic Test: Cognitive test

Interventions

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.

Alzheimers disease (AD); Dementia with Lewy Bodies (DLB); Healthy Controls (HC)

Cognitive test DIAGNOSTIC_TEST

Minimal Mental State examination (MMSE), Montreal Cognitive Assessment (MoCA)

Alzheimers disease (AD); Dementia with Lewy Bodies (DLB); Healthy Controls (HC)

Motor examination DIAGNOSTIC_TEST

Unified Parkinsons Rating Scale (UPDRS)

Alzheimers disease (AD); Dementia with Lewy Bodies (DLB)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Age 18 - 40 years of age
• Able to cooperate as evaluated by the primary investigator (PI)
• Able to give informed consent

You may not qualify if:

• 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
• 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.
• 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

Sponsors & Collaborators

• Danish Dementia Research Centre: lead
• Danish Reference Center for Prion Diseases, Rigshospitalet: collaborator
• Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet: collaborator

Study Sites (1)

Danish Dementia Research Centre

Copenhagen, 2100, Denmark

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Cerebrospinal fluid, olfactory mucosa, saliva, skin, urine, feces and blood

MeSH Terms

Conditions

Lewy Body Disease; Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Cognition Disorders

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 14, 2023
• Study Start: February 1, 2023
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: October 10, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)