Citations 2
Plasma Phosphorylated Tau 217 to Identify Preclinical Alzheimer Disease
Janelidze, Shorena, Bali, Divya , Dolado, Anna Orduña , Binette, Alexa Pichet , Rahmouni, Nesrine , Blennow, Kaj, Doré, Vincent , Feizpour, Azadeh , Rowe, Christopher C., Villeneuve, Sylvia , Petersen, Ronald C., Jack, Clifford R. , Groups, ADNI, ALFA, and PREVENT-AD Study, Adegoke, Olusegun, Hussen, Kedir Adem, Aisen, Paul, Ajayi, Adeyinka, Amaza, Hannatu, Apostolova, Liana G. , Ashford, Miriam T. , Ayo, Omobolanle, Bernard, Marie , Bernhardt, Haley, Boatwright, Virginia, Borowski, Bret, Brylska, Magdalena, Buckholtz, Neil, Cabrera, Yuliana, Cairns, Nigel J. , Carrillo, Maria, Choe, Mark, Clanton, Taylor, Conti, Cat, Craft, Hannah, Crawford, Karen , DeCarli, Charles , Benedetto, Joseph Di, Diaz, Adam , Drake, Erin, Faber, Kelley, Felmlee, Joel P. , Fidell, Andrea, Flenniken, Derek , Fockler, Juliet , Forghanian-Arani, Arvin, Frank, R.T., Franklin, Erin , Glittenberg, Matt, Gunter, Jeff, Guzmán, Vanessa , Harvey, Danielle, Hedberg, Caitie, Hergesheimer, Lindsey, Hoang, Isabella, Jackson, Jonathan , Jagust, William, Jahanshad, Neda , Jenkins, Cecily, Jiménez, Gustavo , Jin, Chengshi , Kachaturian, Zaven, Kaddurah-Daouk, Rima, Kantarci, Kejal, Karlawish, Jason , Khachaturian, Zaven S., Knaack, Alexander , Korecka, Magdalena , Kormos, Adrienne, Germano, Kaori Kubo, Kwang, Winnie, Lacy, Kaci, Landau, Susan, Lopresti, Brian J. , Magana, Fabiola, Mahboubi, Payam, Malone, Ian G., Masliah, Eliezer , Masterman, Donna, Matoush, Leonard, Miller, Melanie J. , Molchan, Susan, Montine, Tom, Moore-Weiss, John, Neu, Scott, Nosheny, Rachel L. , Ogwang, Sheila, Okonkwo, Ozioma, Parkins, Shaniya, Perrin, Richard J. , Petersen, Ronald, Pizzola, Jeremy, Potter, Zoë, Potter, William Z., Rafii, Michael, Raman, Rema , Reyes, Calvin, Reyes, Denise , Robison, Justin , Chen, Stephanie Rossi, Ryan, Laurie, Sachdev, Pallavi, Saito, Naomi , Salazar, Jennifer, Thao, Mai Seng, Shaffer, Elizabeth , Shaw, Leslie M. , Silverberg, Nina, Strong, Joe, Talavera, Sandra , Taylor‐Reinwald, Lisa, Thal, Leon J., Thomas, Lisa , Thompson, Paul , Tosun, Duygu , Trojanowki, John Q., Sacrey, Diana Truran, Villemagne, Victor L. , Walter, Sarah , Wan, Yang , Ward, Chad, Webb, Caitlin, Weiner, Michael W. , Weisensel, Trinity, Zimmerman, Caileigh, Poirier, Judes, Breitner, John C.S. , Badawy, Mohamed , Baril, Andrée‐Ann, Aguilar, Ricardo A, Gorriti, Annabella B, Gispert, Lidia C, Martinez, Alba C, Iglesias, Ruth D, Julian, Sherezade F, Serra, P, González‐Escalante, Armand , Penas, Laura H, Rodriguez, Gema H, Ninou, Jordi H, Gamaz, Laura Iglesias, Knezevic, Iva, Alvarez, Paula M, Diaz, Tania M, Palacios, Eva , Ballester, A, Mendez, Sandra P, Freixedes, Laura Ros, Vila, Aleix S, Harster, Lluis S, Prat, Anna S, Jaramillo, Marc V, Jack, Clifford R , Feizpour, Azadeh , Doré, Vincent , Pichet Binette, Alexa , Salvadó, Gemma , Janelidze, Shorena , Therriault, Joseph , Brum, Wagner Scheeren , Stomrud, Erik , Mattsson, Niklas , Palmqvist, Sebastian , Coomans, Emma M. , Teunissen, Charlotte E. , Flier, Wiesje M. van der , Benzinger, Tammie L.S. , Gispert, Juan Domingo , Blennow, Kaj , Alcolea, Daniel , Fortea, Juan , Johnson, Sterling C. , Rosa-Neto, Pedro , Schindler, Suzanne E. , Suárez‐Calvet, Marc , Ossenkoppele, Rik , Hansson, Oskar , Groups, ADNI, ALFA, and PREVENT-AD Study, Aisen, Paul , Barnes, Lisa L. , Beckett, Laurel , Das, Sandhitsu R. , Donohue, Michael , Drake, Erin, Erickson, Claire M. , Fletcher, Evan M. , Arani, Arvin , Foroud, Tatiana , Fox, Nick C. , Frank, Richard, González, Hector, Green, Robert C. , Grill, Joshua D. , Harkins, Kristin , Ho, Carole , Hsiao, John , Jo, Taeho, Kaddurah‐Daouk, Rima , Kantarci, Kejal , Koeppe, Robert A. , Largent, Emily A. , Lee, Edward B. , Lee, Virginia M.‐Y. , Morris, John C. , Nho, Kwangsik T. , Nir, Talia M. , Nudelman, Kelly , Okonkwo, Ozioma, Petersen, Ronald, Rabinovici, Gil D. , Rafii, Michael S. , Reid, Robert, Reyes, Denise, Risacher, Shannon L. , Mindt, Mónica Rivera , Sachdev, Pallavi, Saykin, Andrew J. , Schwarz, Christopher G. , Senjem, Matthew L. , Li, Shen , Smith, Stephanie R. , Snyder, Peter J. , Thomopoulos, Sophia I. , Toga, Arthur W. , Vemuri, Prashanthi , Yushkevich, Paul A. , Badawy, Mohamed, Baillet, Sylvain , Minguillón, Carolina , Brugulat‐Serrat, Anna , Cacciaglia, Raffaele , Campo, Marta del , Pascual, Maria, Rodríguez‐Fernández, Blanca , Vilor‐Tejedor, Natàlia
JAMA Neurology | September 15, 2025 | Volume: 82 | Issue: 11 | Pages: 1122
Importance Advances in Alzheimer disease (AD) have shifted research focus to earlier disease stages, necessitating more scalable approaches to identify cognitively unimpaired individuals with amyloid β (Aβ) pathology. Objective To assess the utility of plasma phosphorylated tau 217 (p-tau217) for classifying Aβ status in cognitively unimpaired individuals, both as a stand-alone test and in a 2-step approach where positive plasma results were confirmed using a second modality (Aβ positron emission tomography [PET] or cerebrospinal fluid [CSF]). Design, Setting, and Participants This cross-sectional cohort study used data collected between June 2009 and March 2024. We included 2916 cognitively unimpaired participants from 12 international independent observational cohorts in the US, Europe, Australia, and Canada with available plasma p-tau217 levels and CSF or PET Aβ biomarkers. Performance comparisons between mass spectrometry and immunoassay-based p-tau217 measurements were also performed (n = 964). Exposures Plasma p-tau217 levels measured by immunoassay. Main Outcome and Measures Aβ status, determined by CSF or Aβ PET biomarkers. Results Participants had a mean (SD) age of 66.9 (9.9) years; 971 (33.3%) were Aβ positive by either CSF or PET, 1667 (57.2%) were women, and 1108 (38.1%) carried at least 1 APOE ε4 allele. As a stand-alone test, plasma p-tau217 achieved a positive predictive value (PPV) of 79% (95% CI, 74-84) and an overall accuracy of 81% (95% CI, 80-82). In a 2-step workflow, the PPV and accuracy significantly increased to 91% (95% CI, 86-95). While this approach required screening of 677 individuals with plasma p-tau217 to identify 100 Aβ-positive individuals, compared to 536 participants when using PET alone, it reduced the need for PET testing to 124. Immunoassays demonstrated comparable PPVs to mass spectrometry (80% [95% CI, 74-86] vs 85% [95% CI, 81-90]; P = .12) but significantly lower overall accuracy (82% [95% CI, 79-84]% vs 88 [95% CI, 86-90]; P < .001) and true Aβ-positive detection rate (49% [95% CI, 43-55] vs 69% [95% CI, 64-75]; P < .001). Conclusions and Relevance The findings highlight the potential of plasma p-tau217 as a stand-alone test—or when used in a sequential 2-step approach alongside PET or CSF testing—as a cost-effective, scalable, and minimally burdensome strategy for identifying preclinical AD. Tailored screening workflows that incorporate p-tau217 can improve efficiency in participant selection for preclinical AD trials and, in the future, help guide access to disease-modifying treatments.
A Protocol for the Inclusion of Minoritized Persons in Alzheimer Disease Research From the ADNI3 Diversity Taskforce
Okonkwo, Ozioma C. , Ashford, Miriam T. , Conti, Catherine , Strong, Joe, Raman, Rema , Nosheny, Rachel L. , Flenniken, Derek , Miller, Melanie J. , Diaz, Adam , Soto, Annabelle M., Ances, Beau M. , Beigi, Maryam , Doraiswamy, P. Murali , Duara, Ranjan , Farlow, Martin R. , Grossman, Hillel, Mintzer, Jacobo , Reist, Christopher , Rogalskı, Emily , Sabbagh, Marwan N. , Salloway, Stephen, Schneider, Lon S. , Petersen, Ronald C. , Aisen, Paul , Weiner, Michael W., Initiative, Alzheimer’s Disease Neuroimaging, Ances, Beau M , Mindt, Mónica Rivera , Donohue, Michael , Duara, Ranjan , Shah, Raj C. , Initiative, Alzheimer’s Disease Neuroimaging
JAMA Network Open | August 9, 2024 | Volume: 7 | Issue: 8 | Pages: e2427073
10.1001/jamanetworkopen.2024.27073
ImportanceBlack or African American (hereinafter, Black) and Hispanic or Latino/a/x (hereinafter, Latinx) adults are disproportionally affected by Alzheimer disease, but most research studies do not enroll adequate numbers of both of these populations. The Alzheimer’s Disease Neuroimaging Initiative-3 (ADNI3) launched a diversity taskforce to pilot a multipronged effort to increase the study inclusion of Black and Latinx older adults.ObjectiveTo describe and evaluate the culturally informed and community-engaged inclusion efforts to increase the screening and enrollment of Black and Latinx older adults in ADNI3.Design, Setting, and ParticipantsThis cross-sectional study used baseline data from a longitudinal, multisite, observational study conducted from January 15, 2021, to July 12, 2022, with no follow-up. The study was conducted at 13 ADNI3 sites in the US. Participants included individuals aged 55 to 90 years without cognitive impairment and those with mild cognitive impairment or Alzheimer disease.ExposuresEfforts included (1) launch of an external advisory board, (2) changes to the study protocol, (3) updates to the digital prescreener, (4) selection and deployment of 13 community-engaged research study sites, (5) development and deployment of local and centralized outreach efforts, and (6) development of a community-science partnership board.Main Outcomes and MeasuresScreening and enrollment numbers from centralized and local outreach efforts, digital advertisement metrics, and digital prescreener completion.ResultsA total of 91 participants enrolled in the trial via centralized and local outreach efforts, of which 22 (24.2%) identified as Latinx and 55 (60.4%) identified as Black (median [IQR] age, 65.6 [IQR, 61.5-72.5] years; 62 women [68.1%]). This represented a 267.6% increase in the monthly rate of enrollment (before: 1.11 per month; during: 4.08 per month) of underrepresented populations. For the centralized effort, social media advertisements were run between June 1, 2021, and July 31, 2022, which resulted in 2079 completed digital prescreeners, of which 1289 met criteria for subsequent site-level screening. Local efforts were run between June 1, 2021, to July 31, 2022. A total of 151 participants underwent site-level screening (100 from local efforts, 41 from centralized efforts, 10 from other sources).Conclusions and RelevanceIn this cross-sectional study of pilot inclusion efforts, a culturally informed, community-engaged approach increased the inclusion of Black and Latinx participants in an Alzheimer disease cohort study.