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ENROLLING BY INVITATION
NCT03514524
NA

Synaptic Density, Tau and Multiparametric PET-MR in Brain Trauma, Stroke and Mild Cognitive or Behavioral Impairment.

Sponsor: Universitaire Ziekenhuizen KU Leuven

View on ClinicalTrials.gov

Summary

Alzheimer's disease, stroke and TBI are frequently observed brain disorders, causing significant morbidity. For none of these disorders, there are in vivo diagnostic biomarkers available that allow determination of disease burden, patient-specific prognosis and therapy follow-up. However, they all share a similar mechanism that may cause accumulation of tau oligomers in the brain, synaptic dysfunction and cognitive and/or behavioral impairment. Until recently, the only way to quantify synaptic density and tau deposition was using post-mortem immunohistochemistry. Now, in vivo Positron Emission Tomography (PET) imaging of synaptic density has become possible trough development of 11C-UCB-J, a levetiracetam-based radioligand, expressing high affinity and specificity for SV2A. Furthermore, the novel radioligand 18F-MK-6240, specifically targeting tau deposits, was clinically implemented in our center. Through PET-MR, we can visualize the cascade of tau deposition, synaptic loss and degeneration of grey and white matter and relate these pathologic features to cognitive and behavioral deterioration. The goal of the study is to: 1) measure tau deposition and loss of synaptic density in these conditions as a potential measure for disease load 2) determination of the mid-term (2 years) monitoring capacity of combined functional-structural PET-MR imaging 3) relate progression of the imaging markers to cognitive and/or behavioral decline and 4) determination of the optimal combination of PET-MR metrics for early identification and risk-stratification of cognitive and/or behavioral dysfunction in de novo patients.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

150

Start Date

2018-02-01

Completion Date

2025-09

Last Updated

2024-07-03

Healthy Volunteers

Yes

Interventions

OTHER

PET-MR imaging

Both 18F-MK-6240 and 11C-UCB-J PET-MR will be performed at base-line (all arms) 6 months after TBI/stroke (TBI and stroke arm) and after 2 years (TBI, stroke, CTE and MCI/MBI arls)

Locations (1)

Division of nuclear medicine and molecular imaging, University Hospital Leuven

Leuven, Belgium