Actively Recruiting

Age: 50Years - 85Years
All Genders
ID05059158

Amyloid-beta Clearance Mechanisms: A Multi-modal Study on Lymphatic, Glymphatic and Blood-brain-barrier Function in Alzheimer's Disease

Led by Ludwig-Maximilians - University of Munich · Updated on 2025-07-04

60

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating how the brain clears amyloid-beta protein plaques, focusing on the blood-brain barrier, glymphatic system, brain lymphatic system, and enzymatic breakdown. The study includes participants with Subjective Cognitive Decline, Mild Cognitive Impairment, and mild Alzheimer's disease to better understand these clearance mechanisms and their relationship to disease progression. The study uses advanced imaging methods such as 18-Flutemetamol positron emission tomography (PET) scans, MRI, and cerebrospinal fluid analysis to examine amyloid-beta deposits and blood-brain barrier function. Participants will also wear actigraphy devices to monitor sleep and activity patterns. The study involves a single assessment period without follow-up, aiming to develop a comprehensive model of amyloid-beta clearance and its interaction with brain systems. Participants will undergo detailed clinical and neuropsychological evaluations following a standardized protocol. Researchers will measure differences in blood-brain barrier disruption, clearance mechanisms, brain network connectivity, and the role of sleep in amyloid-beta pathology. The study will last for one visit per participant, including imaging, laboratory tests, and activity monitoring, with no follow-up planned in this phase.

CONDITIONS

Brief Title

Amyloid-β Clearance Mechanisms in Alzheimer's Disease

Who Can Participate

Age: 50Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of amnestic Mild Cognitive Impairment or Alzheimer's Disease dementia or clinical normal
  • Able to provide written informed consent
  • Unchanged pharmacotherapy within 4 days prior to the study specific assessments
  • Fluent in German
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 1 day

Participants undergo detailed clinical and neuropsychological assessments, including MRI, PET scans, cerebrospinal fluid collection, and actigraphy to examine amyloid-beta clearance mechanisms.

1 visit (in-person)

Long-term Monitoring

Duration - No follow-up assessments in this project

Participants are observed to study the connection between clinical symptoms, brain-blood-barrier disruption, and amyloid-beta pathology without follow-up assessments in this study.

No visits

Trial Site Locations

Total: 1 location

1

Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums

München, Bavaria, Germany, 80336

Actively Recruiting

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Research Team

R

Robert Perneczky, Prof.Dr.med.

L

Lena Burow, M.Sc.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

3

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