Please Wait...

Microhemorrhage Findings on Baseline Rosas MRI Data

H. Basselerie1, L. Bracoud2, H.M. Schneble3, S. Gouttard2, I. Guignot3, A. Istace2, F. Roche2, J. Schaerer2, M. Pueyo3, C. Pachai2, B. Vellas1, F. Bonneville1    1 CHU Toulouse, France  2 BioClinica, Lyon, France - email: luc.bracoud@bioclinica.com  3 Institut de Recherches Internationales Servier, Suresnes, France

INTRODUCTION

  • Cerebral microhemorrhages, although common among the elderly, are known to be related to the presence of amyloid in the brain, cognitive impairment and dementia severity.
  • This work assesses the prevalence of microhemorrhages in ROSAS, a monocentric observational study which includes normal controls as well as MCI and AD subjects.

METHODS

Population

  • The ROSAS study is a monocentric observational study which ran in Toulouse, France, and was designed to identify and evaluate the clinical usefulness of AD biomarkers by collecting samples from Normal Controls (NC), Mild Cognitive Impairment (MCI) and AD subjects, following them for up to 4 years.
  • Subjects aged 65 years or older were enrolled, including Normal Controls (NC, no memory complaints, MMSE≥26 and CDR=0), Mild Cognitive Impairment (MCI, MMSE≥24 and CDR=0.5, memory impairment based on RAVLT and who did not meet DSM IV criteria for AD dementia) and AD (12≤MMSE≤26 and CDR≥0.5 and meeting DSM IV criteria).

MRI Data

  • Susceptibility-Weighted (SWI) MRI scans were collected up to 3 times between Baseline and Month 48, at one site using a Philips Achieva 3T scanner, for consenting subjects (n=153, including 51 NC, 41 MCI and 61 AD).
  • 3DT1 data consisted of an axial VenoBOLD High-Resolution sequence with a 1x1x1 mm3 acquisition voxel size, reconstructed in each direction at ~ 0.5 mm.
  • Minimum Intensity Projection (minIP) reconstructed slices were centrally generated (6 mm thick, with 3 mm overlap).

Image review and analysis

  • Baseline SWI data (both native and minIP) were reviewed by one rater.
  • Bleeds were categorized by location and size, as follows:
    • Deep: deep gray matter (basal ganglia and thalamus) and white matter of the corpus callosum, internal, external, and extreme capsule
    • Lobar: cortical gray matter and subcortical or periventricular white matter
    • Infratentorial: brain stem and cerebellum
  • Bleeds were further classified by size, as being < 5 mm, between 5 and 10 mm (so-called large microhemorrhages) or > 10 mm.
  • Descriptive statistics were computed for each group.
  • Pearson Chi-Square tests were used to assess differences between groups.

RESULTS

  • Microhemorrhages (≤10mm) were reported on 56.9% NC, 68.3% MCI and 65.6% AD.
  • Only 2.0% NC had more than 4 microhemorrhages, as compared to 22.0% MCI and 11.5% AD.
  • Significant differences between groups were found for the presence of infratentorial microhemorrhages (p=0.035) and of >4 microhemorrhages (p=0.01), and between NC and non-NC for the presence of large microhemorrhages (p=0.045) and >4 lobar microhemorrhages (p=0.029).
  • Bleeds >10 mm were found on only 2 MCI and 2 AD.

CONCLUSIONS

  • A majority of ROSAS subjects from all clinical categories had ≥1 microhemorrhage.
  • Multiple (>4), multiple lobar (>4), large (5-10 mm in size) and infratentorial microhemorrhages were significantly more frequent in non-NC subjects.
  • Whether these findings could be a predictor for risk of conversion from MCI to AD will be investigated after the end of the study.

LEARN MORE OR SPEAK WITH OUR EXPERTS

CONTACT US
Leader in Clinical Trial
Management Solutions

Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

Learn about When EDC is not enough: Automating multi-country data collection and complete workflows at #DIA2019! Ja… https://t.co/zJfytNpz82
Bioclinica (3 days ago)
In San Diego for #DIA2019? Visit us at booth #1831 and meet face to face with our team to learn more about our rapi… https://t.co/T4U4oNXlxo
Bioclinica (2 weeks ago)
We're celebrating International #NASH Day to help raise awareness about non-alcoholic steatohepatitis & fatty liver… https://t.co/16PfGbzeaS
Bioclinica (2 weeks ago)
Global site payments automation in clinical trials. Ck it out! https://t.co/QUEhyRMsN4 https://t.co/pZ0ZUviKuv
Bioclinica (4 weeks ago)
Come talk to #Bioclinica at #ASCO19! See why we're the world leader in #oncology imaging, helping to assess efficac… https://t.co/h0ng6StIbU
Bioclinica (4 weeks ago)
Great insights for sponsors conducting #NAFLD #NASH #clinical trials. https://t.co/TG1WwRhVE8 https://t.co/US2Iobjoyd
Bioclinica (5 weeks ago)

Latest Blogs:

Medical Imaging of Non-Alcoholic Fatty Liver Diseases in Clinical Trials
EDC Provider Selection
Site Payments Solutions
Nonalcoholic steatohepatitis (NASH) development programs
Dr. Joby John
Transformational Trends in Investigator Site Payments
Clinical Supply Chain Success: Leveraging Technology
Blood pressure monitor
Prescription box