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Cited by 151Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchNeuroinflammation and Neurodegeneration Mechanisms

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Amyloid-β 11 C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials

Open access
Liu, Enchi, Schmidt, Mark E., Margolin, Richard, Sperling, Reisa, Koeppe, Robert, Mason, Neale S., Klunk, William E., Mathis, Chester A., Salloway, Stephen, Fox, Nick C., Hill, Derek L., Les, Andrea S., Collins, Peter, Gregg, Keith M., Di, Jianing, Lu, Yuan, Tudor, I. Cristina, Wyman, Bradley T., Booth, Kevin, Broome, Stephanie, Yuen, Eric, Grundman, Michael, Brashear, H. Robert, For the Bapineuzumab 301 and 302 Clinical Trial Investigators, Salloway, S., Sperling, R., Raskind, M., Sabbagh, M., Honig, L., Porsteinsson, A., Ferris, S., Weisman, D., Harris, L., Diamond, B., Casher, A., Thomas, V., Rhodes, D., Olivia, C., Years, A., Rosenzweig, A., Klein, B., Arnold, S., Boruta, V., Blue-Schaller, A., McGowan, J., Wurziger, J., Yalkinoglu, O., Wurziger, J., Kirsch, M., Schindler, C., Spirling, A., Ohnesorge, M., Kluge, A., McCartney, M., Stubbs, T., Sweeney, K., Johnson, K., Santangelo, R., Woo, B., DiCarli, M., Williams, S., Passler, J., Cheng, D., Ingram, W., Jutras, S., Shay, M., McGlew, A., Warner-Coviello, S., Nandan, R., Rees, P., Mehra, V., Porras, J., Bryant, S., Bartolome, E., Hoh, C., Murphy, J., Sharif, S., Buchsbaum, M., Kortman, K., Kovacs, I., Chini, N., Brown, L., Alva, G., Alva, A., Kellogg, J., Lykke, M, Rabe, M., Shih, B., Wu, J., Hoh, C., Buchsbaum, M., Tariot, P., Yaari, R., Small, S., Chavira, M., Reiman, E., Brand, H., Cooper, L., Dennis-Busier, W., Bandy, D., Seward, J., Weir, J., Monarrez, C., Branch, D., Langbaum, J., Mohammand, A., Ross, C., Mullen, L., Goodwin, S., Fleisher, A., Burke, A., Jakimovich, L., Costanzo, D., Drimer-Kagan, T., Holt, C., High, N., Wright, K., Reeder, S., Saunders, K., Richter, N., Vadovicky, S., Salomon, E., Lopez, R., Frantz, M., Minero, J., Langlois, C., Chana, G., Hamilton, E., Media-Rodriguez, S., LeFranc, D., Luk, M., Martin, A., Weiler, K., Baker, M., Martinez-Lujan, L., Sabbagh, M., Jacobson, S., Belden, C., Holladay, D., Cottam, R., Shill, H., Edwards, J., Connor, D., Davis, K., Allinich, D., Sala, J., Covert, M., Ceimo, J., Molnar, C., Malek-Ahmadi, M., Schwartz, E., Conrad, P., Lopez, J., Karoll, E., Rangel, A., Delco, C., Obradov, Z., Kohl, K., Montalvo, B., Bandy, D., Chong, C., Stern, R., Nair, A., Green, R., Kopits, I., Barest, G., Nadgir, R., Mandell, A., Gokce, N., Mwicigi, J., Mian, A., Wang, J., Rossi, C., Poon, S., Callaghan, J., Sakai, O., Hong, H., Raghavan, S., Joshi, P., Cook, E., Johnson, K., Steinberg, E., McGowan, T., DiCarli, M., Johnson, P., Qui, W., Marshall, G., Rentz, D., McGinnis, S., Johnson, K., Olson, L., Frey, M., Atri, A., Searl, M., Sperling, R., Mountz, J., Frishe, K., Vitolo, O., Amariglio, R., Di Carli, M., Vliet, M. 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Previto, Townsend, N., Houssami, Y., Brazeale, M., Rozin, S., Krendel, D., Kennedy, P., Schiff, A., Williamson, M., Mohajermilani, Y., Cutsuries, A., Michelli, M., Meltzer, C., Brufoldt, S., Chandler, S., Flemister, C., Whiting, M., Gbadebo, D., Mayo, S., Jackson, R., Caltabiano, N., Hazelrig, C., Mudd, A., Itzcovich-Schuster, J., Malamed, M., Schreiber, M., Ettlinger, R., Brown, M., Grosz, Y., Resille, L., Smith, W., Matsoyan, N., Schuster, R., Rose, E., Hayes, M., Wu, J., Labunsky, L., Svidler, D., Neal, C., Ramirez, V., Hosseini, S., Ossinalde, C., Haider, J., Winston, J., Whitehead, C., Simpson, C., Eisenberg, L., Walker, D., McColl, R., Plopper, M., Ayers, C., Berkowitz, A., Buchsbaum, M., Buda, M., Cary, D., Coughlin, J., Dang, K., Dobrina, M., Geriak, M., Hessling, T., Highum, J., Hoh, C., LoCascio, C., Morache, C., Nicolas, F., Pirlliman, C., Tecca, D., Woods, L., Kalafer, M, Pressman, P., Lyman, M., Cummins, A., Wilkening, A., Lombardo, S., Dobi, A., Geiger, A., Levin, A., Lombardo, C., Arnold, S., Lobatz, M., Blumenfeld, A., Heinen, J., Rosenberg, J., Schim, J., Sanchez, G., Chippendale, T., O’Neill-Conover, C., Sadoff, M., Wang, A., Soto, E., Frishberg, B., Sahagian, G., Tenorio, A., Hinkle, L., Oh, I., Hoh, C., Brower, J., Banker, L., Buchsbaum, M., Brewer, J., Lehmer, M., Vanderswag, H., Fontaine, D., Peavy, G., Buchsbaum, M., Jenkins, C., Gigliotti, C., Gonzales, J., Espinoza, S., Hoh, C., Pierce, A., Sun, J., Da Pena, E., Espinoza, R., Sherzai, A., Caccavale, T., Tam, S., Wilson, A., Preda, A., Potkin, S., Faziola, L., Nguyen, D., Kemp, A., Wu, J., Ramsey, G., Pellicer, R., Shah, N., Plon, L., Upton, J., Hannaford, D., Highurn, D., Milne, N., Barbas, N., Heidebrink, J., Shah, G., Giordani, B., Lord, J., Rothley, J., Woon, F., Votruba, K., Cline, C., Wilson, S., Hammers, D., Powells, D., Michalski, L., Coulas, T., Franti, L., Ford, A., McFadden, M., Lopez, O., Sweet, R., Macedonia, L., Aizenstein, H., Berman, S., Baumgartner, T., Sarles, E., Rothfus, W., Doyle, J., Mountz, J., Simpson, D., Heyman, R., Zachariah, W., Ruszhiewicz, J., Klunk, W., McDade, E., Rickard, C., Greenberg, K., Wolk, D., Asthana, S., Gleason, C., Carlsson, C., Barczi, S., Johnson, S., Johnston, S., Sivesind, P., Zugin, Z., Markgraf, T., Christian, B., Mueller, B., Blazel, H., Harding, S., Sachs, J., Wroblewski, M., Gassman, M., van Dyck, C., Tampi, R., Aziz, R., Friedman, G., Whang, P., Reech, K., Benincasa, A., Wiemers, S., MacAvoy, M., Frye, T., Vinci, M., Barcelos, N., Hu, J., Corsi, M., Nishimura, N., Oellette, P., Ryan-Parsch, C., Lopez, J., Mayeri, S., Shamsi, M., Taylor, S., Ricitelli, D., Azar, B., Beltran, C., Chivukulu, R., Correa, P., Wiznia, L., Cheng, D., Vallabhaneni, S., Patel, S., Henry, S., Werdiger, N., Cleves-Bayon, J., Wiechers, I., Paturzo, K., Nygaard, H., Bowen, G., Brisibe, T., Laborde-Lahoz, P., Wagner, A., Nespoli, M, De Asis, S., Good, S.·2015·Neurology
DOI 10.1212/wnl.0000000000001877PMC PMC4553028
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Abstract

OBJECTIVE: To evaluate the effects of bapineuzumab on brain β-amyloid (Aβ) burden using (11)C-Pittsburgh compound B ((11)C-PiB)-PET. METHODS: Two phase 3 clinical trials, 1 each in apolipoprotein APOE ε4 carriers and noncarriers, were conducted in patients with mild to moderate Alzheimer disease dementia. Bapineuzumab, an anti-Aβ monoclonal antibody, or placebo, was administered by IV infusion every 13 weeks for 78 weeks. PET substudies assessed change in brain fibrillar Aβ over 71 weeks using an (11)C-PiB-PET standardized uptake value ratio (SUVr) global cortical average (GCA) comprising the average SUVr from 5 cortical regions of interest with cerebellar gray matter as the reference region. RESULTS: A total of 115 carriers and 39 noncarriers were analyzed. The difference (δ) in mean baseline to 71 week change in (11)C-PiB-PET GCA between bapineuzumab and placebo was significant in carriers (0.5 mg/kg vs placebo δ = -0.101; p = 0.004) and in pooled analyses of both carriers and noncarriers (0.5 mg/kg vs placebo δ = -0.068; p = 0.027; 1.0 mg/kg vs placebo δ = -0.133; p = 0.028) but not in the noncarrier trial separately. Analyses by individual region of interest and in mild disease yielded findings similar to the main trial results. CONCLUSIONS: The (11)C-PiB-PET imaging results demonstrated reduction of fibrillar Aβ accumulation in patients with Alzheimer disease treated with bapineuzumab; however, as no clinical benefit was observed, the findings are consistent with the hypotheses that bapineuzumab may not have been initiated early enough in the disease course, the doses were insufficient, or the most critical Aβ species were inadequately targeted.

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Liu, E., Schmidt, M. E., Margolin, R., Sperling, R., Koeppe, R., Mason, N. S., Klunk, W. E., Mathis, C. A., Salloway, S., Fox, N. C., Hill, D. L., Les, A. S., Collins, P., Gregg, K. M., Di, J., Lu, Y., Tudor, I. C., Wyman, B. T., Booth, K., Broome, S., Yuen, E., Grundman, M., Brashear, H. R., For the Bapineuzumab 301 and 302 Clinical Trial Investigators, Salloway, S., Sperling, R., Raskind, M., Sabbagh, M., Honig, L., Porsteinsson, A., Ferris, S., Weisman, D., Harris, L., Diamond, B., Casher, A., Thomas, V., Rhodes, D., Olivia, C., Years, A., Rosenzweig, A., Klein, B., Arnold, S., Boruta, V., Blue-Schaller, A., McGowan, J., Wurziger, J., Yalkinoglu, O., Wurziger, J., Kirsch, M., Schindler, C., Spirling, A., Ohnesorge, M., Kluge, A., McCartney, M., Stubbs, T., Sweeney, K., Johnson, K., Santangelo, R., Woo, B., DiCarli, M., Williams, S., Passler, J., Cheng, D., Ingram, W., Jutras, S., Shay, M., McGlew, A., Warner-Coviello, S., Nandan, R., Rees, P., Mehra, V., Porras, J., Bryant, S., Bartolome, E., Hoh, C., Murphy, J., Sharif, S., Buchsbaum, M., Kortman, K., Kovacs, I., Chini, N., Brown, L., Alva, G., Alva, A., Kellogg, J., Lykke, M., Rabe, M., Shih, B., Wu, J., Hoh, C., Buchsbaum, M., Tariot, P., Yaari, R., Small, S., Chavira, M., Reiman, E., Brand, H., Cooper, L., Dennis-Busier, W., Bandy, D., Seward, J., Weir, J., Monarrez, C., Branch, D., Langbaum, J., Mohammand, A., Ross, C., Mullen, L., Goodwin, S., Fleisher, A., Burke, A., Jakimovich, L., Costanzo, D., Drimer-Kagan, T., Holt, C., High, N., Wright, K., Reeder, S., Saunders, K., Richter, N., Vadovicky, S., Salomon, E., Lopez, R., Frantz, M., Minero, J., Langlois, C., Chana, G., Hamilton, E., Media-Rodriguez, S., LeFranc, D., Luk, M., Martin, A., Weiler, K., Baker, M., Martinez-Lujan, L., Sabbagh, M., Jacobson, S., Belden, C., Holladay, D., Cottam, R., Shill, H., Edwards, J., Connor, D., Davis, K., Allinich, D., Sala, J., Covert, M., Ceimo, J., Molnar, C., Malek-Ahmadi, M., Schwartz, E., Conrad, P., Lopez, J., Karoll, E., Rangel, A., Delco, C., Obradov, Z., Kohl, K., Montalvo, B., Bandy, D., Chong, C., Stern, R., Nair, A., Green, R., Kopits, I., Barest, G., Nadgir, R., Mandell, A., Gokce, N., Mwicigi, J., Mian, A., Wang, J., Rossi, C., Poon, S., Callaghan, J., Sakai, O., Hong, H., Raghavan, S., Joshi, P., Cook, E., Johnson, K., Steinberg, E., McGowan, T., DiCarli, M., Johnson, P., Qui, W., Marshall, G., Rentz, D., McGinnis, S., Johnson, K., Olson, L., Frey, M., Atri, A., Searl, M., Sperling, R., Mountz, J., Frishe, K., Vitolo, O., Amariglio, R., Di Carli, M., Vliet, M. V., Horkey, L., Larvie, M., Donovan, N., Lorius, N., Boot, B., Sapir, D., Roy, K., Kim, S., Salloway, S., Lederer, D., Fennelly, W., Blackham, B., Primack, J., Monast, D., Kechichian, C., Malloy, P., Sofios, V., Weinman, S., Santoro, R., Mello, K., Maxwell, C., Gardner, M., Rickler, K., McLaughlin, N., Johnson, K., Tirpaeck, L., Jerue, D., Piryatinsky, I., Di Carli, M., Cheng, D., Marsland, R., Read, P., Mikos, A., Medeiros, D., Kinney, F., Dahl, D., Thurstin, A., May, R., Reeves, H., Garner, R., Steele, T., Tolbert, L., Lindbergh, K., Redwine, M., Hammel, J., Savage, R., White, S., Kirby, N., Wang, X., Berg, S., Rosenberg, G., Campopiano, M., Dobkin, L., Richard-Aasen, S., Champ, J., Dutka, C., Celanovic, M., Minkel, J., Wilson, J., Belt, N., Flamm, L., Kasdan, R., Katz, D., Chandler, L., Clegg, R., Duncan, H., Moutz, J., Harris, J., Gautier, C., Champ, L., Reid, V., Ravella, C., Garg, P., Jones, C., Pulford, K., DeSantis, M., Annas, T., Moore, C., Kunze, J., Garg, P., Lail, J., Kirby, K., Doherr, C., Barker, J., Wang, X., Berg, S., Rosenberg, G., Campopiano, M., Dobkin, L., Richard-Aasen, S., Champ, J., Dutka, C., Celanovic, M., Minkel, J., Wilson, J., Belt, N., Flamm, L., Kasdan, R., Katz, D., Chandler, L., Clegg, R., Duncan, H., Moutz, J., Harris, J., Gautier, C., Champ, L., Reid, V., Ravella, C., Garg, P., Jones, C., Pulford, K., Omidvar, O., Goenjian, A., Patel, N., Walling, D., Cohen, A., Harris, A., Stephens, J., Mori, C., Arceo, F., Brand, J., Segui, C., Foster, E., Cabral, A., Iler, R., Bonomo, G., Freinhar, J., Huy, M., Wu, J., Kemp, M., Issa, C., Reynolds, S., Bui, D., Marlotte, L., Britton, C., Lachica, R., Webb, C., Guinto, A., Zaky, C., Te, S., Tanimura, C., Fukuma, A., Lloyd, C., Wise, A., Lam, P., Botros, D., Rosas, L., Boyd, G., Gladding, R., Becker, S., Norris, A., Flores, A., Parikh, A., Baker, L., Stephens, D., Martinez, M., Keenan, C., Waight, T., Ho, T., Lorine, K., Ramezan-Arab, N., Yang, V., Yang, C., Kashani, S., Spoor, K., Ayele, E., Honig, L., Bell, K., Janicki, S., Dominguez-Rivera, E., Tejeda, R., Cheng, D., Ichise, M., Gordillo, M., Mules, L., Rocha, A., Steinerman, J., Noble, J., Nash, M., Olson, D., Miller, J., Schindler, K., Turknett, J., Yarbrough, G., Panter, C., Thomas-Seaton, L., Young, K., Myers, S., Vedanarayanan, L., Golson, S., Previto-Craft, L., Bruflodt, A., Krendel, D., Kennedy, P., Schiff, A., Williamson, M., Houssami, Y., Rozin, S., Townsend, N., Brazeale, A., Mohajermilani, Y., Cutsuries, A., Micheli, M., Meltzer, C., Bruflodt, S., Chandler, S., Flemister, C., Whiting, M., Gbadebo, D., Mayo, S., Jackson, R., Caltabiano, N., Hazelrig, C., Marks, D. 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Affiliations
  • Brigham and Women's Hospital (US)
  • From Janssen Alzheimer Immunotherapy Research & Development, LLC (E.L., R.M., P.C., K.M.G., J.D., Y.L., I.C.T., S.B., E.Y., H.R.B.), South San Francisco, CA; Janssen Pharmaceutical (M.E.S.), Beerse, NV; Brigham & Women's Hospital (R.S.), Boston, MA; University of Michigan (R.K.), Ann Arbor; University of Pittsburgh (N.S.M., W.E.K., C.A.M.), PA; Butler Hospital (S.S.), Providence, RI; UCL Institute of Neurology (N.C.F.), London, UK; IXICO plc (D.L.H., A.S.L.), London, UK; Pfizer Inc. (B.T.W.)...
  • Pfizer (United States) (US)
  • Butler Hospital (US)
ORCID
Venue
Neurology
Publisher
Ovid Technologies (Wolters Kluwer Health)
Published
2015-08-25
Volume
85
Issue
8
Pages
692-700
ISSN
  • 0028-3878 (ISSN-L)
  • 1526-632X
DOI
10.1212/wnl.0000000000001877
PMC
PMC4553028
OpenAlex
W1824074994
Cited by
151
References
24
Citations by year
2026: 4 · 2025: 10 · 2024: 4 · 2023: 11 · 2022: 13 · 2021: 14 · 2020: 13 · 2019: 15 · 2018: 14 · 2017: 19 · 2016: 25 · 2015: 8
FWCI
16.21
Type
journal article
Language
en
Open access
Locations
  • Neurology (publishedVersion)
  • PubMed Central (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institute for Health and Care Research (NF-SI-0513-10134, NF-SI-0508-10123)
  • National Institute on Aging (P01AG025204, RF1AG025516, P50AG005133, P01AG014449, P30AG008051, U01AG028526, P50AG005134, R37AG025516, R01AG025516)
Topics
  • Life Sciences › Neuroscience › Cellular and Molecular Neuroscience › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Life Sciences › Neuroscience › Neurology › Neuroinflammation and Neurodegeneration Mechanisms
Keywords
bapineuzumab, Alzheimer's disease, amyloid-beta, 11C-PiB PET, Pittsburgh compound B, anti-amyloid monoclonal antibodies, APOE ε4 carriers, brain amyloid burden, amyloid fibrils, treatment response, early treatment initiation, dose adequacy
MeSH terms
Aged, Aged, 80 and over, Alzheimer Disease, Aniline Compounds, Cerebral Cortex, Female, Heterozygote, Humans, Male, Middle Aged, Thiazoles, Amyloid beta-Peptides, Treatment Outcome, Positron-Emission Tomography, Benzothiazoles, Apolipoprotein E4, Antibodies, Monoclonal, Humanized

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This page
CoChat. (2026). Citation check: Amyloid-β 11 C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials. https://app.cochat.ai/papers/10.1212/wnl.0000000000001877
The paper
Liu, E., Schmidt, M. E., Margolin, R., Sperling, R., Koeppe, R., Mason, N. S., Klunk, W. E., Mathis, C. A., Salloway, S., Fox, N. C., Hill, D. L., Les, A. S., Collins, P., Gregg, K. M., Di, J., Lu, Y., Tudor, I. C., Wyman, B. T., Booth, K., . . . Good, S. (2015). Amyloid-β 11 C-PiB-PET imaging results from 2 randomized bapineuzumab phase 3 AD trials. Neurology. https://doi.org/10.1212/wnl.0000000000001877