Clinical Research Update
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1 Clinical Research Update Adam L. Boxer, M.D., Ph.D. Endowed Professor in Memory and Aging Director, AD and FTD Clinical Trials Program Director, Neurosciences Clinical Research Unit University of California, San Francisco PSP/CBD Research Update and Practical Conference Saturday, October 28, 2017; Foster City
2 Disclosures NIH U54NS092089, R01AG038791, U01AG University of California Cures AD Program, Tau Research Consortium, Bluefield Project to Cure FTD, Association for Frontotemporal Degeneration, CBD Solutions, Alzheimer s Drug Discovery Foundation, Alzheimer s Association Industry research support: Avid, Biogen, BMS, C2N, Cortice, Forum, Genentech, Eli Lilly, Roche, TauRx Industry consulting: Abbvie, Alector, Asceneuron, Celgene, Delos, Ionis, Janssen, Merck, Novartis
3 Multidisciplinary intensive rehabilitation therapy (MIRT) week intervention
4 Tau therapeutic targets Boxer et al., Lancet Neurology, 2017
5 Clinical status of PSP therapies Microtubule stabilizing agents o Epothilone D (abandoned) -- AD o Davunetide (abandoned) MCI & PSP o Abeotaxane (TPI-287) Phase 1 AD, CBD, PSP Post-translational modification/aggregation o Methylene blue (LMTM) Phase 3 AD(-), bvftd (-) o Tideglusib (GSKi; abandoned) AD, PSP o O-glc-NACase inhibitors PSP planned o Salsalate (acetylation) Phase 1 PSP, AD Anti-sense oligonucleotides (Phase 1, AD) Immunotherapies to tau or phospho-tau o mabs: Multiple agents in Phase 1-2 PSP, AD o Active vaccines: Phase 1 Other approaches o Young plasma infusions Phase 1 AD, PSP o Hypnotics (suvorexant and zolpidem) remote clinical trial
6 Challenges for PSP therapeutic development Late diagnosis (advanced disease) Clinical heterogeneity Rare disease (enough patients?) Narrow pipeline (need more drugs to test)
7 Movement Variant PSP diagnosis Richardson s Richardson s (PSP-RS/ (PSP-RS/ NINDS-SPSP) NINDS-SPSP) PSP-Parkinson s PSP-Parkinson s (PSP-P) (PSP-P) Pure Pure akinesia akinesia with with gait gait freezing freezing (PSP-PGF) (PSP-PGF) Behavior Corticobasal Corticobasal syndrome syndrome (PSP-CBS) (PSP-CBS) Richardson s Richardson s (PSP-RS/ (PSP-RS/ NINDS-SPSP) NINDS-SPSP) 100% accurate by final visit Eye movements Falls Axial rigidity Bulbar o Cognitive o Behavior Progressive Progressive nonfluent nonfluent aphasia aphasia (PSP-SL) (PSP-SL) PSP PSP neuropathology neuropathology Frontotemporal Frontotemporal dementia dementia (PSP-F) (PSP-F) Psychiatric Psychiatric Dysexecutive Dysexecutive 4R > 3R tau Neuronal loss Williams and Lees; Lancet Neurol 2009; 8: Hoglinger, Mov. Disorders, 2017 Boxer, Lancet Neurology, 2017
8 Disease progression in PSP current trials CBS nfvppa Gait freezing Parkinsonism Prevention Trials Biomarkers Boxer et al., Lancet Neurology, 2017
9 Mov Disord Jun;32(6):
10 U54NS U01AG R01AG038791
11 Clinical Research Networks 18 ARTFL, LEFTDS and 4RTNI sites
12 Participants LEFFTDS through 8/2017
13 vmri change in PSP, CBS Dutt, et al. Neurology 87, 2016
14 F-AV1451: 33 PSP-Richardson s Syndrome > 46 healthy controls 18 PSP: 10 UCSF/LBL, 4 MGH, 19 Avid A09 study 23 males, age 69.6, mean PSP-RS T 9.4 P < Uncor. Schonhaut et al., Annals of Neurology :
15 Low CSF ptau bad in PSP Elevated CSF ptau associated with AD pathology Rojas, et al., Neurology, in press
16 Investigators Biospecimens Genotyping MRI Data Sharing Art Toga Tatiana Foroud Giovanni Coppola Kejal Kantarci Adam Boxer Kelley Faber Karen Crawford Rosa Rademakers Denise Reyes Howard Rosen Madeline Potter Kaely Thostenson Brad Boeve Fellows: Richard Tsai; Jaya Padmanabhan Brian Appleby Management: Hilary Heuer Anna Karydas Matt Miller Yvette Bordelon Cate Freyer Caitlin Glennon Bradford Dickerson Pilot Project PIs: Gil Rabinovici, Ted Huey, Emily Rogalski-Miller Kimiko Domoto-Reilly Research Coordinators Nupur Ghoshal Christina Caso Amy Halpin Masood Manoochehri Gayathri Cheran Elvira Jimenez Tahlee Marian Neill Graff-Radford Reilly Dever Lynne Jones Laura Martindale Murray Grossman Christina Dheel Sheila Joshi Emily McKinley Edward Huey Sophia Dominguez Ruth Kraft Namita Multani Ann Fishman Samantha Krivensky Pheth Sengdy Robin Hsiung Behnaz Ghazanfari Denise Ledlow Kimberley Thomas David Irwin Dana Haley Fran Lissemore Jana Windsor Daniel Kaufer Funding Diana Kerwin David Knopman Irene Litvan Ian Mackenzie Patient Advocacy Group Partners Mario Mendez Alex Pantelyat Erik Roberson Carmela Tartaglia Sandra Weintraub
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