By InvitationNot Applicable

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

Belgium150 participantsStarted 2018-02-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Healthy volunteers Age between 18 and 80 years old (15 subjects between 18-50 yrs and 25 subjects between 50-80 yrs) Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs and clinical laboratory tests. No evidence of neurological disorder as evidenced by neurological examination No evidence of cognitive impairment as assessed by a MMSE score \>= 28. In subjects \< 60 years of age, an unremarkable structural MRI scan as assessed by expert radiologist. In subjects \>= 60 years of age white matter hyperintensities corresponding to a WML (white matter lesion) score \<= 2 (of 3) on the Age-Related White Matter changes scale are acceptable. The volunteer is willing to undergo an additional 11C-PIB amyloid scan when cerebral amyloid status is unknown (if known, should have been performed in the year before inclusion). * TBI Age between 18 and 60 years of age Patient suffered a first TBI episode 1-4 weeks prior to inclusion * CTE Age between 30 and 80 years of age Patient is recently diagnosed with CTE Patient has known amyloid status (assessed \< 1year ago) or is willing to undergo additional amyloid scanning. * Stroke Age between 30 and 80 years of age Patient suffered a first episode of stroke 1-4 weeks prior to inclusion * aMCI / MBI Age between 50 and 80 years of age Patient is diagnosed with aMCI due to AD according to the Albert criteria (27) or with MBI according to the…

What they're measuring

changes in synaptic density with age or due to TBI, stroke or MCI/MBI

Timeframe: 2 years

changes in tau-depositions with age or due to TBI, stroke or MCI/MBI

Timeframe: 2 years

Monitoring capacities of these novel functional/structural imaging techniques

Timeframe: 3 years

Relationship between synaptic density and tau deposition and cognitive/behavioral decline in normal ageing and in TBI, stroke and MCI/MBI.

Timeframe: 4 years

Trial details

NCT IDNCT03514524

SponsorUniversitaire Ziekenhuizen KU Leuven

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02

View on ClinicalTrials.gov More Neuro-Degenerative Disease trials

Plain-language summary

Who can participate

Age range18 Years – 80 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

changes in synaptic density with age or due to TBI, stroke or MCI/MBI

Timeframe: 2 years

changes in tau-depositions with age or due to TBI, stroke or MCI/MBI

Timeframe: 2 years

Monitoring capacities of these novel functional/structural imaging techniques

Timeframe: 3 years

Relationship between synaptic density and tau deposition and cognitive/behavioral decline in normal ageing and in TBI, stroke and MCI/MBI.

Timeframe: 4 years