Amyloid-β Clearance Mechanisms in Alzheimer's Disease
Germany60 participantsStarted 2021-06-01
Plain-language summary
The focus of this study is to examine the protein-plaque clearance (Aß) in relation to the blood-brain-barrier, the glymphatic system, brain lymphatic system and enzymatic degradation. In order to achieve this aim the investigators intend to study participants with a Subjective Cognitive Decline, Mild Cognitive Impairment and a mild Alzheimer's disease.
Who can participate
Age range
50 Years – 85 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:
* Diagnosis of amnestic MCI or AD dementia or clinical normal
* Able to provide written informed consent
* Unchanged pharmacotherapy within 4 days prior to the study specific assessments
* Fluent in German
Exclusion Criteria:
* Unable to give informed consent or has a legal guardian
* Other severe mental disorder, e.g. schizophrenia or bipolar affective disorder
* Clinically relevant depression
* Acute suicidality
* Current alcohol, drug or medication abuse
* History of severe traumatic brain injury within 3 months prior to inclusion
* Structural lesions of the basal ganglia or brain stem
* Severe neurological disorder including (but not limited to) epilepsy, systemic disorders, stroke, repeated transient ischaemic attacks, increased brain intracranial pressure, normal pressure hydrocephalus
* Severe medical disorders including (but not limited to) heart failure, respiratory failure, uncontrolled severe arterial hypertension
* Electronic implants (e.g. cardiac pacemaker) or other MRI contraindication
* Renal failure \> stage 3 (GFR \< 30 mL/min)
* Pregnancy
* Unresolved malignancies within two years prior to inclusion
* Severe current infections or other chronic or systemic disorders
* Other circumstances which preclude participation based on the investigator's judgement
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
Differences in the disruption of the brain-blood-barrier between the subgroups
Timeframe: Baseline
2
Clearance mechanisms and glymphatic or cerebral lymphatic system
Timeframe: Baseline
3
Connection between the structural/functional connectivity of the resting networks and the clearance mechanisms
Timeframe: Baseline
4
Differences between sleep and activity in SCD, MCI and AD; Do they have a mediator role in association of the BBB disruption and Aß pathology?
Timeframe: Baseline
5
Connection between clinical symptoms, Aß pathology and BBB disorder