DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia (NCT05768425) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
DIagnostic Biomarkers and Symptoms in Patients With Alzheimer's Disease and Lewy bodY Dementia
Denmark55 participantsStarted 2023-02-01
Plain-language summary
This a study to improve diagnosis of dementia with Lewy bodies with RT-QuIC in different biospecimens.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy of Real-time quaking-induced conversion
Timeframe: 24 months
2
Diagnostic accuracy of Real-time quaking-induced conversion
Timeframe: 24 months
3
Diagnostic accuracy of Real-time quaking-induced conversion