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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05059158
Other study ID # 18-606
Secondary ID 18-6061081
Status Recruiting
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date June 2024

Study information

Verified date October 2023
Source Ludwig-Maximilians - University of Munich
Contact Robert Perneczky, Prof.Dr.med.
Phone +4989440055863
Email PSY.Alzheimerzentrum@med.uni-muenchen.de
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date June 2024
Est. primary completion date June 2024
Accepts healthy volunteers No
Gender All
Age group 50 Years to 85 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Radiation:
positron emission tomography (PET)
18-Flutemetamol PET (clinical indicated) is going to be performed at the visit.

Locations

Country Name City State
Germany Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums München Bayern

Sponsors (1)

Lead Sponsor Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
Primary 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
Primary 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
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