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

Ludwig Maximilian University of Munich

Status

Enrolling

Conditions

Alzheimer's Disease (AD)

Treatments

Radiation: positron emission tomography (PET)

Study type

Observational

Funder types

Other

Identifiers

NCT05059158

18-606 (Other Grant/Funding Number)

1081

Details and patient eligibility

About

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.

Full 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.

Enrollment

60 estimated patients

Sex

All

Ages

50 to 85 years old

Volunteers

No Healthy Volunteers

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