Please Wait...

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

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.

Reminder: Today's webinar on Clinical Endpoint Adjudication kicks off at 1 PM Eastern. > https://t.co/1IU9TVFCFA
bioclinica (2 days ago)
In a new go-to-guide on conducting #Alzheimer's clinical trials, @bioclinica experts Joyce Suhy, Marieke Cajal, Luc… https://t.co/SaBFm3L9CL
bioclinica (3 days ago)
Clinical Endpoint Adjudication Webinar. Join us in a live online event this Friday, (6/15) Details & reg. > https://t.co/uBjlgSMnDS
bioclinica (3 days ago)
Clinical Endpoint Adjudication webinar this Friday! Interested in establishing a universal clinical vocabulary to i… https://t.co/uPD992tSaY
bioclinica (4 days ago)
RT @Pints4PDOrlando: Amazingly grateful to @BioclinicaFLA @bioclinica for their super generous donation to @michaeljfoxorg @teamfox in our…
bioclinica (4 days ago)
RT @E_de_Azambuja: ESMO at ASCO2018: please visit booth 5078 if you want more information on ESMO activities and opportunities @myESMO #asc…
bioclinica (2 weeks ago)

Latest Blogs:

Latin America: Benefit from the Right Partner
Removing Risk from Clinical Trial Management System (CTMS) Implementations
Collaboration Between Clinical Operations and the Logistics and Supply Chain Teams is Key to Trial Success
The Value of Protocol Review
CTMS and RBM: Hot Topics at OCT Nordics in Copenhagen