Amyloid-β Clearance Mechanisms in Alzheimer's Disease

NCT05059158 | Recruiting

• 2 other identifiers: 18-6061081
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer's Disease (AD)

Keywords

Alzheimer's Disease; Mild Cognitive Impairment; Sleep; Actigraphy; Blood-brain-barrier; Amyloid-β Clearance Mechanisms

Outcome Measures

Primary Outcomes (5)

• Differences in the disruption of the brain-blood-barrier between the subgroups

  Name of Measurement: Ktrans; Measurement Tool: DCI sequence (MRI); Unit: min -1

  Baseline

• Clearance mechanisms and glymphatic or cerebral lymphatic system

  Can a disruption in the cerebral clearance through the glymphatic or cerebral lymphatic system be proven in patients with AD, MCI or SCD? Name of Measurement: DTI ALPS; Measurement Tool: DTI MRI; Unit: mean (Dxpro, Dypro)/ mean (Dypro, Dzasc)

  Baseline

• Connection between the structural/functional connectivity of the resting networks and the clearance mechanisms

  Correlations between correlations of bold fluctuations/ number of tracts and DTI ALPS Index

  Baseline

• 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?

  Name of Measurement: Sleep Efficiency, Sleep Time, PIM, TAT, ZCM ;Measurement Tool: Actigraphy; Units: minutes, count

  Baseline

• Connection between clinical symptoms, Aß pathology and BBB disorder

  Correlations between Clinical Dementia Rating Sum of Boxes, CSF markers (pg/ml) and Aß PET, SUVr and Ktrans map

  Baseline

Study Arms (3)

Alzheimer's Disease

Patients with a Alzheimer's Disease diagnosis

Radiation: positron emission tomography (PET)

Mild Cognitive Impairment

Patients with a mild cognitive impairment diagnosis

Radiation: positron emission tomography (PET)

Subjective Cognitive Decline

Patients with a subjective cognitive decline diagnosis

Radiation: positron emission tomography (PET)

Interventions

positron emission tomography (PET) RADIATION

18-Flutemetamol PET (clinical indicated) is going to be performed at the visit.

Alzheimer's Disease; Mild Cognitive Impairment; Subjective Cognitive Decline

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SCD, MCI or AD

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• Severe current infections or other chronic or systemic disorders
• Other circumstances which preclude participation based on the investigator's judgement

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums

München, Bavaria, 80336, Germany

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Robert Perneczky, Prof.Dr.med.

  Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Perneczky, Prof.Dr.med.

CONTACT

+4989440055863; PSY.Alzheimerzentrum@med.uni-muenchen.de

Lena Burow, M.Sc.

CONTACT

+4989440055898; lena.burow@med.uni-muenchen.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: September 28, 2021
• Study Start: June 1, 2021
• Primary Completion: September 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Locations

DE (1)