Neurodegenerative Diseases

Crenezumab exposure–response across AD endpoints supports a higher dose for phase 3

Polamus D, Rogers J, Paul R, Kshirsagar S, Sahasranaman S, Jin JY, Quartino AL.  Presented at the 9th Annual Clinical Trials on Alzheimer’s Disease (CTAD), December 2016.

Facilitating clinical trial simulation in Alzheimer’s disease using the CAMD IPD, literature summary level data, and the ‘adsim’ R package

Polhamus D.  Presented at The Joint Statistical Meetings (JSM), August, 2016.

Facilitating clinical trial simulation in Alzheimer's disease using the CAMD IPD, literature summary level data, and the 'adsim' R package

Polhamus D.  Presented at The Joint Statistical Meetings (JSM), August, 2016.

An integrated natural disease progression model of nine cognitive and biomarker endpoints in patients with Alzheimer’s Disease

Angelica Quartino, Dan Polhamus, James Rogers, and Jin Jin. Presented at the Population Approach Group Europe (PAGE), Alicante, 2014. Abstract 3187.

Clinical dementia rating modeling and simulation: Joint progression of CDR and biomarkers in the ADNI cohort

Polhamus DG, Rogers JA, Gillespie WR, French J. Presented at the Alzheimer’s Association International Conference (AAIC),  2013.

Application of modeling and simulation to support clinical drug development decisions in Alzheimer’s disease

Gastonguay MR.  Presented at First Indiana Clinical and Translational Sciences Institute (CTSI) Symposium on Disease and Therapeutic Response Modeling. Indiana University – Purdue University Indianapolis; Indianapolis, IN; November 13, 2011.

Population pharmacokinetic-pharmacodynamic analysis of istradefylline in patients with Parkinson disease

Knebel W, Rao N, Uchimura T, Mori A, Fisher J, Gastonguay MR, and Chaikin P. The Journal of Clinical Pharmacology, 2012; 52: 1468–1481. doi:10.1177/0091270011420566.

Combining patient-level and summary-level data for Alzheimer’s disease modeling and simulation: A beta regression meta-analysis

Rogers JA, Polhamus D, Gillespie WR, Ito K, Romero K, Qiu R, Stephenson D, Gastonguay MR, Corrigan B. J Pharmacokinet Pharmacodyn. October 2012, Volume 39, Issue 5, pp 479-498.

Avagacestat (BMS-708163) exposures and study discontinuations in patients with mild-to-moderate Alzheimer’s disease

Abu Tarif M, Kaplita S, Berman RM, Coric V, Baron K.  Presented at the Alzheimer’s Association International Conference (AAIC), Vancouver, BC, July 2012.

Model-based analysis to support strategic decision making: A case study from the development of a 5HT6 antagonist for the treatment of Alzheimer’s disease

Rogers J, Lockwood P, Polhamus D, Brault Y, Desmet A, Ito K, Romero K, Qiu R, Gillespie W, Corrigan B, Gastonguay M.  Presented at the Alzheimer’s Association International Conference (AAIC), Vancouver, BC, July 2012.

From evidence synthesis to trial optimization: The adsim package for model-based simulation in Alzheimer’s disease

Polhamus D, Rogers J, Gillespie W, French J, and Gastonguay M.  Presented at the 21st Annual Meeting of the Population Approach Group Europe (PAGE), Venice, Italy, June 2012, Abstract 2580.

The value of evidence synthesis: Model-based meta-analysis based on the CAMD database, the ADNI AD cohort data, and literature meta-data

Rogers J, Polhamus D, Ito K, Qiu R, Gillespie W, Corrigan B. Presented at the 2012 American Society for Clinical Pharmacology and Therapeutics (ASCPT) Annual Meeting, National Harlbor, MD; March 2012.