Alzheimer Disease Clinical Trial
— DISPLAYOfficial title:
DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia - DISPLAY
Verified date | October 2023 |
Source | Danish Dementia Research Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens.
Status | Active, not recruiting |
Enrollment | 55 |
Est. completion date | December 2032 |
Est. primary completion date | December 2032 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Denmark | Danish Dementia Research Centre | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Danish Dementia Research Centre | Danish Reference Center for Prion Diseases, Rigshospitalet, Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Rigshospitalet |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Diagnostic accuracy of Real-time quaking-induced conversion | Specificity | 24 months | |
Primary | Diagnostic accuracy of Real-time quaking-induced conversion | Sensitivity | 24 months | |
Primary | Diagnostic accuracy of Real-time quaking-induced conversion | Area under the curb | 24 months | |
Secondary | Sense of smell | Test with Sniffin Sticks 16, Score 0- 16 points | 24 months | |
Secondary | Dysautonomia | Unified Parkinsons Rating Scale part I 0-52 | 24 months | |
Secondary | Motor functions | Unified Parkinsons Rating Scale part III Score range: 0-132 | 24 months | |
Secondary | Cognitive function | Montreal Cognitive Assesment (MoCA) Score range: 0-30 | 24 months | |
Secondary | Cognitive function | Minimal Mental State Examination (MMSE) Score range: 0-30 | 24 months |
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