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Update and trends on pharmacokinetic studies in patients with impaired renal function: practical insight into application of the FDA and EMA guidelines.

Paglialunga S, Offman E, Ichhpurani N, Marbury TC, Morimoto BH.

Expert Rev Clin Pharmacol. 2017 Mar;10(3):273-283. doi: 10.1080/17512433.2017.1274651. Epub 2017 Jan 29. Review.


Progression of brain atrophy in PSP and CBS over 6 months and 1 year.

Dutt S, Binney RJ, Heuer HW, Luong P, Attygalle S, Bhatt P, Marx GA, Elofson J, Tartaglia MC, Litvan I, McGinnis SM, Dickerson BC, Kornak J, Waltzman D, Voltarelli L, Schuff N, Rabinovici GD, Kramer JH, Jack CR Jr, Miller BL, Rosen HJ, Boxer AL; AL-108-231 investigators.

Neurology. 2016 Nov 8;87(19):2016-2025. Epub 2016 Oct 14.


Predicting disease progression in progressive supranuclear palsy in multicenter clinical trials.

Bang J, Lobach IV, Lang AE, Grossman M, Knopman DS, Miller BL, Schneider LS, Doody RS, Lees A, Gold M, Morimoto BH, Boxer AL; AL-108-231 Investigators.

Parkinsonism Relat Disord. 2016 Jul;28:41-48. doi: 10.1016/j.parkreldis.2016.04.014. Epub 2016 Apr 18.


Safety Pharmacology in Drug Discovery and Development.

Morimoto BH, Castelloe E, Fox AW.

Handb Exp Pharmacol. 2015;229:65-80. doi: 10.1007/978-3-662-46943-9_3. Review.


Intranasal NAP (davunetide) decreases tau hyperphosphorylation and moderately improves behavioral deficits in mice overexpressing α-synuclein.

Magen I, Ostritsky R, Richter F, Zhu C, Fleming SM, Lemesre V, Stewart AJ, Morimoto BH, Gozes I, Chesselet MF.

Pharmacol Res Perspect. 2014 Oct;2(5):e00065. doi: 10.1002/prp2.65. Epub 2014 Aug 6.


Davunetide in patients with progressive supranuclear palsy: a randomised, double-blind, placebo-controlled phase 2/3 trial.

Boxer AL, Lang AE, Grossman M, Knopman DS, Miller BL, Schneider LS, Doody RS, Lees A, Golbe LI, Williams DR, Corvol JC, Ludolph A, Burn D, Lorenzl S, Litvan I, Roberson ED, Höglinger GU, Koestler M, Jack CR Jr, Van Deerlin V, Randolph C, Lobach IV, Heuer HW, Gozes I, Parker L, Whitaker S, Hirman J, Stewart AJ, Gold M, Morimoto BH; AL-108-231 Investigators.

Lancet Neurol. 2014 Jul;13(7):676-85. doi: 10.1016/S1474-4422(14)70088-2. Epub 2014 May 27.


Davunetide: a review of safety and efficacy data with a focus on neurodegenerative diseases.

Morimoto BH, Fox AW, Stewart AJ, Gold M.

Expert Rev Clin Pharmacol. 2013 Sep;6(5):483-502. doi: 10.1586/17512433.2013.827403. Epub 2013 Aug 24. Review.


A double-blind, placebo-controlled, ascending-dose, randomized study to evaluate the safety, tolerability and effects on cognition of AL-108 after 12 weeks of intranasal administration in subjects with mild cognitive impairment.

Morimoto BH, Schmechel D, Hirman J, Blackwell A, Keith J, Gold M; AL-108-211 Study.

Dement Geriatr Cogn Disord. 2013;35(5-6):325-36. doi: 10.1159/000348347. Epub 2013 Apr 13.


Drug development of intranasally delivered peptides.

Campbell C, Morimoto BH, Nenciu D, Fox AW.

Ther Deliv. 2012 Apr;3(4):557-68. Review.


Critical appraisal of the role of davunetide in the treatment of progressive supranuclear palsy.

Gold M, Lorenzl S, Stewart AJ, Morimoto BH, Williams DR, Gozes I.

Neuropsychiatr Dis Treat. 2012;8:85-93. doi: 10.2147/NDT.S12518. Epub 2012 Feb 9.


Localized hippocampus measures are associated with Alzheimer pathology and cognition independent of total hippocampal volume.

Carmichael O, Xie J, Fletcher E, Singh B, DeCarli C; Alzheimer's Disease Neuroimaging Initiative.

Neurobiol Aging. 2012 Jun;33(6):1124.e31-41. doi: 10.1016/j.neurobiolaging.2011.08.016. Epub 2011 Dec 14.


Detecting global and local hippocampal shape changes in Alzheimer's disease using statistical shape models.

Shen KK, Fripp J, Mériaudeau F, Chételat G, Salvado O, Bourgeat P; Alzheimer's Disease Neuroimaging Initiative.

Neuroimage. 2012 Feb 1;59(3):2155-66. doi: 10.1016/j.neuroimage.2011.10.014. Epub 2011 Oct 14.


Individual subject classification for Alzheimer's disease based on incremental learning using a spatial frequency representation of cortical thickness data.

Cho Y, Seong JK, Jeong Y, Shin SY; Alzheimer's Disease Neuroimaging Initiative.

Neuroimage. 2012 Feb 1;59(3):2217-30. doi: 10.1016/j.neuroimage.2011.09.085. Epub 2011 Oct 8.


BEaST: brain extraction based on nonlocal segmentation technique.

Eskildsen SF, Coupé P, Fonov V, Manjón JV, Leung KK, Guizard N, Wassef SN, Østergaard LR, Collins DL; Alzheimer's Disease Neuroimaging Initiative.

Neuroimage. 2012 Feb 1;59(3):2362-73. doi: 10.1016/j.neuroimage.2011.09.012. Epub 2011 Sep 16.


Mild cognitive impairment: baseline and longitudinal structural MR imaging measures improve predictive prognosis.

McEvoy LK, Holland D, Hagler DJ Jr, Fennema-Notestine C, Brewer JB, Dale AM; Alzheimer's Disease Neuroimaging Initiative.

Radiology. 2011 Jun;259(3):834-43. doi: 10.1148/radiol.11101975. Epub 2011 Apr 6.


Using CSF biomarkers to replicate genetic associations in Alzheimer's disease.

Schott JM; ADNI Investigators.

Neurobiol Aging. 2012 Jul;33(7):1486.e9-15. doi: 10.1016/j.neurobiolaging.2011.02.008. Epub 2011 Apr 3.


Spatial patterns of brain amyloid-beta burden and atrophy rate associations in mild cognitive impairment.

Tosun D, Schuff N, Mathis CA, Jagust W, Weiner MW; Alzheimer's Disease NeuroImaging Initiative.

Brain. 2011 Apr;134(Pt 4):1077-88. doi: 10.1093/brain/awr044. Epub 2011 Mar 22.


Fine mapping of genetic variants in BIN1, CLU, CR1 and PICALM for association with cerebrospinal fluid biomarkers for Alzheimer's disease.

Kauwe JS, Cruchaga C, Karch CM, Sadler B, Lee M, Mayo K, Latu W, Su'a M, Fagan AM, Holtzman DM, Morris JC; Alzheimer's Disease Neuroimaging Initiative, Goate AM.

PLoS One. 2011 Feb 9;6(2):e15918. doi: 10.1371/journal.pone.0015918.


Revision of the criteria for Alzheimer’s disease: A symposium.

DeKosky ST, Carrillo MC, Phelps C, Knopman D, Petersen RC, Frank R, Schenk D, Masterman D, Siemers ER, Cedarbaum JM, Gold M, Miller DS, Morimoto BH, Khachaturian AS, Mohs RC.

Alzheimers Dement. 2011 Jan;7(1):e1-12.


A pilot trial of the microtubule-interacting peptide (NAP) in mice overexpressing alpha-synuclein shows improvement in motor function and reduction of alpha-synuclein inclusions.

Fleming SM, Mulligan CK, Richter F, Mortazavi F, Lemesre V, Frias C, Zhu C, Stewart A, Gozes I, Morimoto B, Chesselet MF.

Mol Cell Neurosci. 2011 Mar;46(3):597-606. doi: 10.1016/j.mcn.2010.12.011. Epub 2010 Dec 27.

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