التفاصيل البيبلوغرافية
| العنوان: |
Donanemab in early symptomatic Alzheimer disease : the TRAILBLAZER-ALZ 2 randomized clinical trial |
| المؤلفون: |
Sims, John R., Zimmer, Jennifer A., Evans, Cynthia D., Lu, Ming, Ardayfio, Paul, Sparks, JonDavid, Wessels, Alette M., Shcherbinin, Sergey, Wang, Hong, Monkul Nery, Emel Serap, Collins, Emily C., Solomon, Paul, Salloway, Stephen, Apostolova, Liana G., Hansson, Oskar, Ritchie, Craig, Brooks, Dawn A., Mintun, Mark, Skovronsky, Daniel M., Abreu, Rafael, Agarwal, Pinky, Aggarwal, Puja, Agronin, Marc, Allen, Alison, Altamirano, Dario, Alva, Gustavo, Andersen, James, Anderson, Allan, Anderson, Donald, Arnold, Jennifer, Asada, Takashi, Aso, Yasuhiro, Atit, Vikram, Ayala, Ricardo, Badruddoja, Michael, Badzio-jagiello, Hanna, Bajacek, Michal, Barton, David, Bear, David, Benjamin, Sabrina, Bergeron, Richard, Bhatia, Perminder, Black, Sandra, Block, Allan, Bolouri, Mohammad, Bond, Wendy, Bouthillier, Jean, Brangman, Sharon, Brew, Bruce, Brisbin, Sarah, Brisken, Toby, Brodtmann, Amy, Brody, Mark, Brosch, Jared, Brown, Celia, Brownstone, Paul, Bukowczan, Sylwia, Burns, Jeffrey, Cabrera, Alicia, Capote, Horace, Carrasco, Angel, Cevallos Yepez, Jose, Chavez, Eric, Chertkow, Howard, Chyrchel-paszkiewicz, Urszula, Ciabarra, Anthony, Clemmons, Edward, Cohen, Daniel, Cohen, Robert, Cohen, Ian, Concha, Mauricio, Costell, Brian, Crimmins, Denis, Cruz-pagan, Yvette, Cueli, Adolfo, Cupelo, Robert, Czarnecki, Maciej, Darby, David, Dautzenberg, P.l.j., De Deyn, Peter Paul, De La Gandara, Jose, Deck, Kenneth, Dibenedetto, David, Dibuono, Mark, Dinnerstein, Eric, Dirican, Ahmet, Dixit, Shanker, Dobryniewski, Jacek, Drake, Ryan, Drysdale, Peter, Duara, Ranjan, Duffy, John, Ellenbogen, Aaron, Faradji, Victor, Feinberg, Marc, Feldman, Robert, Fishman, Simon, Flitman, Stephen, Forchetti, Concetta, Fraga, Ivonne, Frank, Andrew, Frishberg, Benjamin, Fujigasaki, Fukase, Hiroyuki, Fumero, Ileana, Furihata, Kenichi, Galloway, Christopher, Gandhi, Rekha, George, Kristi, Germain, Marcel, Gitelman, Darren, Goetsch, Nicholas, Goldfarb, Danielle, Goldstein, Mark, Goldstick, Lawrence, Gonzalez Rojas, Yaneicy, Goodman, Ira, Greeley, David, Griffin, Carl, Grigsby, Eric, Grosz, Daniel, Hafner, Karl, Hart, David, Henein, Sam, Herskowitz, Brad, Higashi, Shinji, Higashi, Yasuto, Ho, Gilbert, Hodgson, Jonathan, Hohenberg, Mark, Hollenbeck, Larry, Holub, Richard, Hori, Tomokatsu, Hort, Jakub, Ilkowski, Jan, Ingram, K. Jennifer, Isaac, Mitchell, Ishikawa, Mitsunori, Janu, Lubos, Johnston, Mark, Julio, William, Justiz, William, Kaga, Tomotsugu, Kakigi, Tatsuya, Kalafer, Marvin, Kamijo, Mikiko, Kaplan, Jeffrey, Karathanos, Michael, Katayama, Sadao, Kaul, Siddharth, Keegan, Andrew, Kerwin, Diana, Khan, Uzma, Khan, Arifulla, Kimura, Noriyuki, Kirk, Gregory, Klodowska, Gabriela, Kowa, Hisatomo, Kutz, Christen, Kwentus, Joseph, Lai, Rosalyn, Lall, Ayesha, Lawrence, Mary, Lee, Elly, Leon, Ramon, Linker, Gary, Lisewski, Pawel, Liss, Jonathan, Liu, Collins, Losk, Scott, Lukaszyk, Ewelina, Lynch, Jennifer, Macfarlane, Stephen, Macsweeney, Josephine, Mannering, Nicholas, Markovic, Oto, Marks, Donald, Masdeu, Joseph, Matsui, Yutaka, Matsuishi, Kunitaka, Mcallister, Peter, Mcconnehey, Brock, Mcelveen, Alvin, Mcgill, Lora, Mecca, Adam, Mega, Michael, Mensah, Jason, Mickielewicz, Anatol, Minaeian, Artin, Mocherla, Bharat, Murphy, Cynthia, Murphy, Paul, Nagashima, Hirotaka, Nair, Anil, Nair, Malini, Nardandrea, John, Nash, Marshall, Nasreddine, Ziad, Nishida, Yoshihiko, Norton, Jeffrey, Nunez, Lazaro, Ochiai, Jun, Ohkubo, Takuya, Okamura, Yasuyuki, Okorie, Eugene, Olivera, Esteban, O'mahony, John, Omidvar, Omid, Ortiz-Cruz, Desiree, Osowa, Alexander, Papka, Michelle, Parker, Alicia, Patel, Paayal, Patel, Ashok, Patel, Meenakshi, Patry, Claude, Peckham, Elizabeth, Pfeffer, Michael, Pietras, Alison, Plopper, Michael, Porsteinsson, Anton, Poulin Robitaille, Raphael, Prins, Niels, Puente, Orlando, Ratajczak, Marcin, Rhee, Margaret, Ritter, Angela, Rodriguez, Ramon, Rodriguez Ables, Lilia, Rojas, Julio, Ross, Jeffrey, Royer, Paule, Rubin, Jay, Russell, David, Rutgers, Sterre Malou, Rutrick, Stephanie, Sadowski, Martin, Safirstein, Beth, Sagisaka, Takafumi, Scharre, Douglas, Schneider, Lon, Schreiber, Curtis, Schrift, Michael, Schulz, Paul, Schwartz, Harvey, Schwartzbard, Julie, Scott, John, Selem, Lissette, Sethi, Pramod, Sha, Sharon, Sharlin, Kenneth, Sharma, Sanjiv, Shiovitz, Thomas, Shiwach, Rajinder, Sladek, Martin, Sloan, Bart, Sorial, Ehab, Sosa, Evelio, Stedman, Mary, Steen, Susan, Stein, Lee, Stolyar, Arkadiy, Stoukides, John, Sudoh, Shinji, Sutton, James, Syed, Junaid, Szigeti, Kinga, Tachibana, Hisatsugu, Takahashi, Yuichi, Tateno, Amane, Taylor, James Dale, Taylor, Kelly, Tcheremissine, Oleg, Thebaud, Adly, Thein, Stephen, Thurman, Louise, Toenjes, Steven, Toji, Hiromasa, Toma, Misaki, Tran, Duc, Tsujimoto, Masashi, Turner, Raymond, Uchiyama, Akiyoshi, Ussorowska, Dorota, Vaishnavi, Sanjeev, Valor, Elena, Vandersluis, Joel, Vasquez, Alberto, Velez, Juan, Verghese, Cherian, Vodickova-borzova, Klaudia, Watson, David, Weidman, David, Weisman, David, White, Alexander, Willingham, Katherine, Winkel, Izabela, Winner, Paul, Winston, Jaron, Wolff, Adam, Yagi, Hideo, Yamamoto, Hideki, Yathiraj, Sanjay, Yoshiyama, Yasumasa, Zboch, Marzena |
| المساهمون: |
TRAILBLAZER-ALZ 2 Investigators |
| المصدر: |
0098-7484 ; JAMA : the journal of the American Medical Association |
| سنة النشر: |
2023 |
| المجموعة: |
IRUA - Institutional Repository van de Universiteit Antwerpen |
| مصطلحات موضوعية: |
Chemistry, Biology, Human medicine |
| الوصف: |
Importance There are limited efficacious treatments for Alzheimer disease. Objective To assess efficacy and adverse events of donanemab, an antibody designed to clear brain amyloid plaque. Design, Setting, and Participants Multicenter (277 medical research centers/hospitals in 8 countries), randomized, double-blind, placebo-controlled, 18-month phase 3 trial that enrolled 1736 participants with early symptomatic Alzheimer disease (mild cognitive impairment/mild dementia) with amyloid and low/medium or high tau pathology based on positron emission tomography imaging from June 2020 to November 2021 (last patient visit for primary outcome in April 2023). Interventions Participants were randomized in a 1:1 ratio to receive donanemab (n = 860) or placebo (n = 876) intravenously every 4 weeks for 72 weeks. Participants in the donanemab group were switched to receive placebo in a blinded manner if dose completion criteria were met. Main Outcomes and Measures The primary outcome was change in integrated Alzheimer Disease Rating Scale (iADRS) score from baseline to 76 weeks (range, 0-144; lower scores indicate greater impairment). There were 24 gated outcomes (primary, secondary, and exploratory), including the secondary outcome of change in the sum of boxes of the Clinical Dementia Rating Scale (CDR-SB) score (range, 0-18; higher scores indicate greater impairment). Statistical testing allocated α of .04 to testing low/medium tau population outcomes, with the remainder (.01) for combined population outcomes. Results Among 1736 randomized participants (mean age, 73.0 years; 996 [57.4%] women; 1182 [68.1%] with low/medium tau pathology and 552 [31.8%] with high tau pathology), 1320 (76%) completed the trial. Of the 24 gated outcomes, 23 were statistically significant. The least-squares mean (LSM) change in iADRS score at 76 weeks was −6.02 (95% CI, −7.01 to −5.03) in the donanemab group and −9.27 (95% CI, −10.23 to −8.31) in the placebo group (difference, 3.25 [95% CI, 1.88-4.62]; P < .001) in the low/medium ... |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| الإتاحة: |
https://doi.org/10.1001/JAMA.2023.13239Test
https://hdl.handle.net/10067/1979740151162165141Test |
| حقوق: |
info:eu-repo/semantics/closedAccess |
| رقم الانضمام: |
edsbas.44490124 |
| قاعدة البيانات: |
BASE |
