Amyloid-β Clearance Mechanisms in Alzheimer's Disease (AmyClearAD)

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    Ludwig-Maximilians - University of Munich
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Updated on 24 January 2025
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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.

Description

In this study, the investigators want to examine the different mechanisms of the accumulation and the clearance of Aß- deposits with imaging methods. One focus of the study is an improved characterisation of a blood-brain-barrier disorder (which seems to have an impact on the Aß-accumulation). Another main aim is to provide an improved mechanistic clearance model, which integrates crucial components such as the recently proposed cerebral glymphatic and lymphatic pathways, and which addresses the interaction between the different components and their individual contribution to Aβ removal from the brain. A possible connection between sleep and an altered transport mechanism will be analysed. The prospective study cohort (N ~60) will include patients with Mild Cognitive Impairment, mild clinical AD and Subjective Cognitive Decline. All study participants will undergo a detailed clinical and neuropsychological assessment according to a standardised protocol (i.a. MRI, PET, CSF, actigraphy).
Follow-up assessments will not be performed in the present project, but are planned in a subsequent study, pending further funding.

Details
Condition Alzheimer's Disease (AD)
Age 50years - 85years
Clinical Study IdentifierNCT05059158
SponsorLudwig-Maximilians - University of Munich
Last Modified on24 January 2025

Eligibility

 Yes No Not Sure

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
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