Examining how the brain clears amyloid-β in Alzheimer's disease
Amyloid-β Clearance Mechanisms: A Multi-modal Study on Lymphatic, Glymphatic and Blood-brain-barrier Function in Alzheimer's Disease
This study is trying to understand how the brain gets rid of a harmful protein in people with early signs of Alzheimer's disease to help find better treatments in the future.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Ludwig-Maximilians - University of Munich Academic / other |
| Locations | 1 site (München, Bavaria) |
| Trial ID | NCT05059158 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the mechanisms behind the accumulation and clearance of amyloid-β (Aβ) deposits in the brain, particularly focusing on the role of the blood-brain barrier and the glymphatic system. Participants with subjective cognitive decline, mild cognitive impairment, and mild Alzheimer's disease will undergo detailed clinical assessments, including MRI and PET imaging, to better understand the interactions affecting Aβ removal. The study aims to develop a mechanistic model of Aβ clearance that could inform future therapeutic strategies. Follow-up assessments are planned for a subsequent study pending funding.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with amnestic mild cognitive impairment or mild Alzheimer's disease who can provide informed consent.
Not a fit: Patients with severe mental disorders, significant neurological conditions, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of Alzheimer's disease pathology and lead to improved treatment strategies for patients.
How similar studies have performed: While the mechanisms of amyloid-β clearance are being actively researched, this specific approach integrating glymphatic pathways is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
München, Bavaria
- Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums — München, Bavaria, Germany (Recruiting)
Study contacts
- Principal investigator: Robert Perneczky, Prof.Dr.med. — Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums
- Study coordinator: Robert Perneczky, Prof.Dr.med.
- Email: PSY.Alzheimerzentrum@med.uni-muenchen.de
- Phone: +4989440055863
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.