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Relationship between Volumetric MRI parameters, APOE4 and MMSE Status at baseline in Verubecestat (MK-8931) Mild-to-Moderate Alzheimer's Disease Phase 2/3 Trial

Cyrille Sur1, Yi Mo1, James Kost1,Tiffini Voss1,Joyce Suhy2, Luc Bracoud2, Joonmi Oh2, David Michelson1, Michael Egan1

 

1Merck and Co Inc, USA; 2Bioclinica, USA

 

BACKGROUND

Volumetric MRI is a well suited biomarker to monitor neurodegenerative processes in Alzheimer’s Disease (AD) patients. Verubecestat (MK-8931), a potent inhibitor of beta secretase (BACE), is being assessed in a Phase 2/3 trial of mild-to-moderate AD subjects (EPOCH study - NCT01739348). We present analyses of baseline volumetric MR images from an initial partial sample of study participants. The relationship between brain anatomical parameters, cognitive status and APOE4 status of the patients is also examined.

METHODS

Participants between ≥ 55 and ≤ 85 years of age with probable AD and an MMSE score ≥ 15 and ≤ 26 were enrolled. Most subjects received an MRI scan at baseline. Using a standardized imaging protocol 3D T1-weighted MRI sequences were collected on various 1.5T and 3T MRI scanners from more than 200 centers worldwide. Images were centrally collected and quality controlled, and then segmented using Freeesurfer at Bioclinica.

Citations:

  • Shi et al., (2009) Hippocampus 19:1055-1064.
  • Tang et al., (2015) J. of Alzheimer’s Disease 47:645-660.
  • Hostage et al., (2013) PLOS one 8:e54483
  • Jack et al., (2002) Neurology 58:750-757.
  • Peng et al., (2015) CNS Neuroscience and Therapeutics 21:15-22.

CONCLUSION

  • EPOCH trial participants showed difference in whole brain atrophy stage between mild and moderate AD  patients.
  • EPOCH trial APOE4 carriers represented over 60% of the enroll subjects and exhibited a higher hippocampal atrophy.
  • In EPOCH trial the left hippocampus of enrolled subjects appears more vulnerable to neurodegeneration than the right hippocampus.
  • Brain structure volume of North American EPOCH trial subjects are consistent with ADNI reported volume data.

 

ACKNOWLEDGMENTS

  • Thanks to the patients, their family, caregivers and principal investigators and their team that are participating in EPOCH trial.
  • Funding for this research was provided by Merck & Co Inc., Kenilworth, NJ, USA

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