NCT05317871

Brief Summary

The project PeptiClear aims to investigate whether the blood-brain-barrier (BBB) and the glymphatic system are compromised in atypical neurodegenerative diseases, and whether Alzheimer´s disease (AD)-related copathology, vascular lesions or sleep disturbances modify the clinical picture or structural and/or functional features of the diseases.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 8, 2022

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

March 9, 2023

Status Verified

March 1, 2023

Enrollment Period

2 years

First QC Date

November 2, 2021

Last Update Submit

March 8, 2023

Conditions

Neurodegenerative DiseasesFrontotemporal Degeneration

Keywords

Neurodegenerative diseasesFrontotemporal DegenerationClearanceBlood-brain-barrierSleepMicroglial activationGlymphatic system

Outcome Measures

Primary Outcomes (4)

  • Disruption of the brain-blood-barrier between the subgroups

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

    Baseline

  • Clearance mechanisms and glymphatic or cerebral lymphatic system

    Name of Measurement: Diffusion tensor imaging (DTI) Analysis along the perivascular space (ALPS); Measurement Tool: DTI MRI; Unit: mean (Dxpro, Dypro)/ mean (Dypro, Dzasc)

    Baseline

  • Changes in circadian rhythms

    Sleep Efficiency, proportional integration mode (PIM) ;Measurement Tool: Actigraphy; Units: counts

    Baseline

  • Correlation between clinical symptoms, tau pathology and BBB disorder

    Correlations between neuropsychological tests (e.g. Clinical Dementia Rating Sum of Boxes), CSF markers (pg/ml) and TAU PET, standardized uptake value ratio (SUVr) and Ktrans map

    Baseline

Study Arms (4)

Lewy Body Spectrum Diseases

Progressive Supranuclear Palsy

Corticobasal Syndrome

Frontotemporal Degeneration

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Atypical neurodegerative diseases: Lewy-Body Spectrum Diseases, Progressive Supranuclear Palsy, Corticobasal Syndrome, Frontemporal Degeneration

You may qualify if:

  • Diagnosis of Atypical Parkinsonian Disorders or Frontotemporal Dementia
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums

München, Bavaria, 80336, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

APOE-genotyping

MeSH Terms

Conditions

Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Nervous System Diseases

Study Officials

  • Robert Perneczky, Prof. Dr.

    Klinik und Poliklinik für Psychiatrie und Psychotherapie des LMU Klinikums

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Robert Perneczky, Prof. Dr.

CONTACT

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

Lena Burow, M.Sc.

CONTACT

+4989440055898lena.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

November 2, 2021

First Posted

April 8, 2022

Study Start

April 1, 2022

Primary Completion

April 1, 2024

Study Completion

April 1, 2024

Last Updated

March 9, 2023

Record last verified: 2023-03

Locations

DE(1)