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Amyloid-β Clearance Mechanisms in Alzheimer's Disease

ConditionAlzheimer's Disease (AD)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age50-85
SponsorLudwig-Maximilians - University of Munich

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

SCD, MCI or AD

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • positron emission tomography (PET)

    Radiation

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

Treatment groups

60 Participants
are divided into 3 treatment groups
Group A: Alzheimer's Disease1 intervention
Group B: Mild Cognitive Impairment1 intervention
Group C: Subjective Cognitive Decline1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
Baseline
2

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)

Time frame
Baseline
3

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

Time frame
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?

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

Time frame
Baseline

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ludwig-Maximilians - University of Munich

Lead sponsor

Source ClinicalTrials.gov
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