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3. Using Digital Tools to Advance Alzheimer’s Drug Trials During a Pandemic: The EU/US CTAD Task Force

Author

Kaye, Jeffrey, Aisen, P, Amariglio, R, Au, R, Ballard, C, Carrillo, M, Fillit, H, Iwatsubo, T, Jimenez-Maggiora, G, Lovestone, S, Natanegara, F, Papp, K, Soto, ME, Weiner, M, and Vellas, B

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Brain Disorders, Clinical Research, Neurosciences, Aging, Neurodegenerative, Clinical Trials and Supportive Activities, Alzheimer's Disease, Acquired Cognitive Impairment, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Dementia, Neurological, Good Health and Well Being, Advisory Committees, Alzheimer Disease, Biomedical Research, COVID-19, Clinical Trials as Topic, Digital Technology, European Union, Humans, United States, Alzheimer’s disease, clinical outcomes, digital tools, remote assessments, Biological psychology, Cognitive and computational psychology
Abstract

The 2020 COVID-19 pandemic has disrupted Alzheimer's disease (AD) clinical studies worldwide. Digital technologies may help minimize disruptions by enabling remote assessment of subtle cognitive and functional changes over the course of the disease. The EU/US Clinical Trials in Alzheimer's Disease (CTAD) Task Force met virtually in November 2020 to explore the opportunities and challenges associated with the use of digital technologies in AD clinical research. While recognizing the potential of digital tools to accelerate clinical trials, improve the engagement of diverse populations, capture clinically meaningful data, and lower costs, questions remain regarding the stability, validity, generalizability, and reproducibility of digital data. Substantial concerns also exist regarding regulatory acceptance and privacy. Nonetheless, the Task Force supported further exploration of digital technologies through collaboration and data sharing, noting the need for standardization of digital readouts. They also concluded that while it may be premature to employ remote assessments for trials of novel experimental medications, remote studies of non-invasive, multi-domain approaches may be feasible at this time.

Published
2021

4. Two Randomized Phase 3 Studies of Aducanumab in Early Alzheimer’s Disease

Author

Budd Haeberlein, Samantha, Aisen, P.S., Barkhof, F., Chalkias, S., Chen, T., Cohen, S., Dent, G., Hansson, O., Harrison, K., von Hehn, C., Iwatsubo, T., Mallinckrodt, C., Mummery, C.J., Muralidharan, K.K., Nestorov, I., Nisenbaum, L., Rajagovindan, R., Skordos, L., Tian, Y., van Dyck, C.H., Vellas, B., Wu, S., Zhu, Y., and Sandrock, A.

Published
2022
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6. A Japanese Multicenter Study on PET and Other Biomarkers for Subjects with Potential Preclinical and Prodromal Alzheimer’s Disease

Author

Senda, Michio, Ishii, K., Ito, K., Ikeuchi, T., Matsuda, H., Iwatsubo, T., Iwata, A., Ihara, R., Suzuki, K., Kasuga, K., Ikari, Y., Niimi, Y., Arai, H., Tamaoka, A., Arahata, Y., Itoh, Y., Tachibana, H., Ichimiya, Y., Washizuka, S., Odawara, T., Ishii, K., Ono, K., Yokota, T., Nakanishi, A., Matsubara, E., Mori, H., and Shimada, H.

Published
2021
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9. Early- and subsequent- response of cognitive functioning in Alzheimer's disease: Individual-participant data from five pivotal randomized clinical trials of donepezil

Author

Levine, SZ, Goldberg, Y, Yoshida, K, Samara, M, Cipriani, A, Iwatsubo, T, Leucht, S, and Furawaka, TA

Subjects
Psychiatry and Mental health, Cognition, Double-Blind Method, Alzheimer Disease, Indans, Humans, Donepezil, Cholinesterase Inhibitors, Nootropic Agents, Biological Psychiatry, Randomized Controlled Trials as Topic
Abstract

The association between early improvement and subsequent change in cognition is unexamined in antidementia clinical trials. We aimed to examine the consequences of early-response to antidementia medication in Alzheimer's disease. Participant-level data were analyzed from five pivotal clinical trials of donepezil for Alzheimer's disease lasting up to 24 weeks (N = 1917). Early-response was based on Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) change scores under minus four from baseline to week six, otherwise classified non-response; then subgrouped by donepezil or placebo. The primary analysis tested the group differences in ADAS-Cog change from baseline for the interval after week six up to 24, based on a three-level mixed-effects model repeated measures (MMRM) model. Four models of increasing complexity were tested, and the most parsimonious model was examined in the primary analysis. The remaining models were tested in sensitivity analysis. In the analytic sample, 32.09% (N = 396/1234) of donepezil and 24.01% (N = 164/683) of placebo participants were classified as early responders, and 67.91% donepezil (N = 838/1234), 75.99% (N = 519/683) placebo participants were not. MMRM identified a statistically significant (P < 0.05) responder group effect. Marginal means (MM) demonstrated more improvement for the early responders (donepezil: MM = −4.13, 95% CI = -5.93, −2.32; placebo MM = 1.81, 95% CI = −4.12, 0.50), compared to non-early responders (donepezil MM = 0.05, 95% CI = -1.40, 1.51; placebo MM = 2.59, 95% CI = 0.99, 4.19). Results replicated in sensitivity analysis. Our results inform clinicians regarding the extent and consequences of early improvement in cognitive functioning and potentially contribute to treatment monitoring and the design of clinical trials for Alzheimer's disease.

Published
2022

10. Chronic neuropsychiatric sequelae of SARS‐CoV‐2: Protocol and methods from the Alzheimer's Association Global Consortium

Author

de Erausquin, G.A., Snyder, H., Brugha, T.S., Seshadri, S., Carrillo, M., Sagar, R., Huang, Y., Newton, C., Tartaglia, C., Teunissen, C., Håkanson, K., Akinyemi, R., Prasad, K., D'Avossa, G., Gonzalez‐Aleman, G., Hosseini, A., Vavougios, G.D., Sachdev, P., Bankart, J., Mors, N.P.O., Lipton, R., Katz, M., Fox, P.T., Katshu, M.Z., Iyengar, M.S., Weinstein, G., Sohrabi, H.R., Jenkins, R., Stein, D.J., Hugon, J., Mavreas, V., Blangero, J., Cruchaga, C., Krishna, M., Wadoo, O., Becerra, R., Zwir, I., Longstreth, W.T., Kroenenberg, G., Edison, P., Mukaetova‐Ladinska, E., Staufenberg, E., Figueredo‐Aguiar, M., Yécora, A., Vaca, F., Zamponi, H.P., Re, V.L., Majid, A., Sundarakumar, J., Gonzalez, H.M., Geerlings, M.I., Skoog, I., Salmoiraghi, A., Boneschi, F.M., Patel, V.N., Santos, J.M., Arroyo, G.R., Moreno, A.C., Felix, P., Gallo, C., Arai, H., Yamada, M., Iwatsubo, T., Sharma, M., Chakraborty, N., Ferreccio, C., Akena, D., Brayne, C., Maestre, G., Blangero, S.W., Brusco, L.I., Siddarth, P., Hughes, T.M., Zuñiga, A.R., Kambeitz, J., Laza, A.R., Allen, N., Panos, S., Merrill, D., Ibáñez, A., Tsuang, D., Valishvili, N., Shrestha, S., Wang, S., Padma, V., Anstey, K.J., Ravindrdanath, V., Blennow, K., Mullins, P., Łojek, E., Pria, A., Mosley, T.H., Gowland, P., Girard, T.D., Bowtell, R., Vahidy, F.S., de Erausquin, G.A., Snyder, H., Brugha, T.S., Seshadri, S., Carrillo, M., Sagar, R., Huang, Y., Newton, C., Tartaglia, C., Teunissen, C., Håkanson, K., Akinyemi, R., Prasad, K., D'Avossa, G., Gonzalez‐Aleman, G., Hosseini, A., Vavougios, G.D., Sachdev, P., Bankart, J., Mors, N.P.O., Lipton, R., Katz, M., Fox, P.T., Katshu, M.Z., Iyengar, M.S., Weinstein, G., Sohrabi, H.R., Jenkins, R., Stein, D.J., Hugon, J., Mavreas, V., Blangero, J., Cruchaga, C., Krishna, M., Wadoo, O., Becerra, R., Zwir, I., Longstreth, W.T., Kroenenberg, G., Edison, P., Mukaetova‐Ladinska, E., Staufenberg, E., Figueredo‐Aguiar, M., Yécora, A., Vaca, F., Zamponi, H.P., Re, V.L., Majid, A., Sundarakumar, J., Gonzalez, H.M., Geerlings, M.I., Skoog, I., Salmoiraghi, A., Boneschi, F.M., Patel, V.N., Santos, J.M., Arroyo, G.R., Moreno, A.C., Felix, P., Gallo, C., Arai, H., Yamada, M., Iwatsubo, T., Sharma, M., Chakraborty, N., Ferreccio, C., Akena, D., Brayne, C., Maestre, G., Blangero, S.W., Brusco, L.I., Siddarth, P., Hughes, T.M., Zuñiga, A.R., Kambeitz, J., Laza, A.R., Allen, N., Panos, S., Merrill, D., Ibáñez, A., Tsuang, D., Valishvili, N., Shrestha, S., Wang, S., Padma, V., Anstey, K.J., Ravindrdanath, V., Blennow, K., Mullins, P., Łojek, E., Pria, A., Mosley, T.H., Gowland, P., Girard, T.D., Bowtell, R., and Vahidy, F.S.

Abstract

Introduction Coronavirus disease 2019 (COVID-19) has caused >3.5 million deaths worldwide and affected >160 million people. At least twice as many have been infected but remained asymptomatic or minimally symptomatic. COVID-19 includes central nervous system manifestations mediated by inflammation and cerebrovascular, anoxic, and/or viral neurotoxicity mechanisms. More than one third of patients with COVID-19 develop neurologic problems during the acute phase of the illness, including loss of sense of smell or taste, seizures, and stroke. Damage or functional changes to the brain may result in chronic sequelae. The risk of incident cognitive and neuropsychiatric complications appears independent from the severity of the original pulmonary illness. It behooves the scientific and medical community to attempt to understand the molecular and/or systemic factors linking COVID-19 to neurologic illness, both short and long term. Methods This article describes what is known so far in terms of links among COVID-19, the brain, neurological symptoms, and Alzheimer's disease (AD) and related dementias. We focus on risk factors and possible molecular, inflammatory, and viral mechanisms underlying neurological injury. We also provide a comprehensive description of the Alzheimer's Association Consortium on Chronic Neuropsychiatric Sequelae of SARS-CoV-2 infection (CNS SC2) harmonized methodology to address these questions using a worldwide network of researchers and institutions. Results Successful harmonization of designs and methods was achieved through a consensus process initially fragmented by specific interest groups (epidemiology, clinical assessments, cognitive evaluation, biomarkers, and neuroimaging). Conclusions from subcommittees were presented to the whole group and discussed extensively. Presently data collection is ongoing at 19 sites in 12 countries representing Asia, Africa, the Americas, and Europe. Discussion The Alzheimer's Association Global Consortium harmoni

Published
2022

12. State-of-the-art of lumbar puncture and its place in the journey of patients with Alzheimer's disease

Author

Hampel, H, Shaw, LM, Aisen, P, Chen, C, Lleo, A, Iwatsubo, T, Iwata, A, Yamada, M, Ikeuchi, T, Jia, JP, Wang, HL, Teunissen, CE, Peskind, E, Blennow, K, Cummings, J, and Vergallo, A

Subjects
system readiness, diagnosis, biomarker, lumbar puncture, Alzheimer's disease, evidence-based guidelines, cerebrospinal fluid
Abstract

Recent advances in developing disease-modifying therapies (DMT) for Alzheimer's disease (AD), and the recognition that AD pathophysiology emerges decades before clinical symptoms, necessitate a paradigm shift of health-care systems toward biomarker-guided early detection, diagnosis, and therapeutic decision-making. Appropriate incorporation of cerebrospinal fluid biomarker analysis in clinical practice is an essential step toward system readiness for accommodating the demand of AD diagnosis and proper use of DMTs-once they become available. However, the use of lumbar puncture (LP) in individuals with suspected neurodegenerative diseases such as AD is inconsistent, and the perception of its utility and safety differs considerably among medical specialties as well as among regions and countries. This review describes the state-of-the-art evidence concerning the safety profile of LP in older adults, discusses the risk factors for LP-associated adverse events, and provides recommendations and an outlook for optimized use and global implementation of LP in individuals with suspected AD.

Published
2022

14. Using Digital Tools to Advance Alzheimer's Drug Trials During a Pandemic: The EU/US CTAD Task Force

Author

Kaye, J, Aisen, P, Amariglio, R, Au, R, Ballard, C, Carrillo, M, Fillit, H, Iwatsubo, T, Jimenez-Maggiora, G, Lovestone, S, Natanegara, F, Papp, K, Soto, ME, Weiner, M, and Vellas, B

Subjects
Clinical Trials as Topic, Digital Technology, Aging, Biomedical Research, Advisory Committees, Clinical Trials and Supportive Activities, Neurosciences, COVID-19, Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD), Neurodegenerative, Alzheimer's Disease, remote assessments, United States, clinical outcomes, Brain Disorders, Good Health and Well Being, Alzheimer Disease, Clinical Research, Neurological, Acquired Cognitive Impairment, Humans, Dementia, European Union, Alzheimer’s disease, digital tools
Abstract

The 2020 COVID-19 pandemic has disrupted Alzheimer's disease (AD) clinical studies worldwide. Digital technologies may help minimize disruptions by enabling remote assessment of subtle cognitive and functional changes over the course of the disease. The EU/US Clinical Trials in Alzheimer's Disease (CTAD) Task Force met virtually in November 2020 to explore the opportunities and challenges associated with the use of digital technologies in AD clinical research. While recognizing the potential of digital tools to accelerate clinical trials, improve the engagement of diverse populations, capture clinically meaningful data, and lower costs, questions remain regarding the stability, validity, generalizability, and reproducibility of digital data. Substantial concerns also exist regarding regulatory acceptance and privacy. Nonetheless, the Task Force supported further exploration of digital technologies through collaboration and data sharing, noting the need for standardization of digital readouts. They also concluded that while it may be premature to employ remote assessments for trials of novel experimental medications, remote studies of non-invasive, multi-domain approaches may be feasible at this time.

Published
2021

15. The Worldwide Alzheimer's Disease Neuroimaging Initiative: ADNI-3 updates and global perspectives

Author

Weber, CJ, Carrillo, MC, Jagust, W, Jack, CR, Shaw, LM, Trojanowski, JQ, Saykin, AJ, Beckett, LA, Sur, C, Rao, NP, Mendez, PC, Black, SE, Li, K, Iwatsubo, T, Chang, C-C, Sosa, AL, Rowe, CC, Perrin, RJ, Morris, JC, Healan, AMB, Hall, SE, Weiner, MW, Weber, CJ, Carrillo, MC, Jagust, W, Jack, CR, Shaw, LM, Trojanowski, JQ, Saykin, AJ, Beckett, LA, Sur, C, Rao, NP, Mendez, PC, Black, SE, Li, K, Iwatsubo, T, Chang, C-C, Sosa, AL, Rowe, CC, Perrin, RJ, Morris, JC, Healan, AMB, Hall, SE, and Weiner, MW

Abstract

The Worldwide Alzheimer's Disease Neuroimaging Initiative (WW-ADNI) is a collaborative effort to investigate imaging and biofluid markers that can inform Alzheimer's disease treatment trials. It is a public-private partnership that spans North America, Argentina, Australia, Canada, China, Japan, Korea, Mexico, and Taiwan. In 2004, ADNI researchers began a naturalistic, longitudinal study that continues today around the globe. Through several successive phases (ADNI-1, ADNI-GO, ADNI-2, and ADNI-3), the study has fueled amyloid and tau phenotyping and refined neuroimaging methodologies. WW-ADNI researchers have successfully standardized analyses and openly share data without embargo, providing a rich data set for other investigators. On August 26, 2020, the Alzheimer's Association convened WW-ADNI researchers who shared updates from ADNI-3 and their vision for ADNI-4.

Published
2021

17. Transcriptomic and genetic studies identify IL-33 as a candidate gene for Alzheimer's disease

Author

Chapuis, J, Hot, D, Hansmannel, F, Kerdraon, O, Ferreira, S, Hubans, C, Maurage, C A, Huot, L, Bensemain, F, Laumet, G, Ayral, A M, Fievet, N, Hauw, J J, DeKosky, S T, Lemoine, Y, Iwatsubo, T, Wavrant-Devrièze, F, Dartigues, J F, Tzourio, C, Buée, L, Pasquier, F, Berr, C, Mann, D, Lendon, C, Alpérovitch, A, Kamboh, M I, Amouyel, P, and Lambert, J C

Published
2009
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22. Is there a relation between APOE expression and brain amyloid load in Alzheimer's disease?

Author

Lambert, J-C., Mann, D., Richard, F., Tian, J., Thaker, U., Merrot, S., Harris, J., Frigard, B., Iwatsubo, T., Lendon, C., and Amouyel, P.

Subjects
Glycoproteins -- Research, Glycoproteins -- Genetic aspects, Gene expression -- Research, Apolipoproteins -- Research, Apolipoproteins -- Genetic aspects, Alzheimer's disease -- Genetic aspects, Alzheimer's disease -- Risk factors, Health, Psychology and mental health
Published
2005

24. Association study of Notch 4 polymorphisms with Alzheimer's disease

Author

Lambert, J.-C., Mann, D., Harris, J., Araria-Goumidi, L., Chartier-Harlin, M.-C., Cottel, D., Iwatsubo, T., Amouyel, P., and Lendon, C.

Subjects
Alzheimer's disease -- Research -- Genetic aspects, Health, Psychology and mental health, Genetic aspects, Research
Abstract

J Neurol Neurosurg Psychiatry 2004;75:377-381. doi: 10.1136/jnnp.2003.017368 Background: The NOTCH4 gene is located at 6p21.3, a site shown in several studies to have significant linkage with Alzheimer's disease. Objective: To [...]

Published
2004

25. Theoretical investigation of an artificial joint with micro-pocket-covered component and biphasic cartilage on the opposite articulating surface

Author

Suciu, A.N., Iwatsubo, T., and Matsuda, M.

Subjects
Artificial joints -- Research, Engineering and manufacturing industries, Science and technology
Abstract

This paper presents a theoretical investigation of a geometrically idealized artificial joint with micro-pocket-covered component and biphasic cartilage on the opposite articulating surface. The fluid that exudes from the biphasic cartilage fills and pressurizes the micropockets. In this way, a poro-elasto-hydrodynamic regime of lubrication is developed. Assuming that lower friction would result in lower adhesive wear, and neglecting the fatigue as well as the abrasive wear, the proposed bearing system hypothetically could reduce the amount of wear debris. Equations of the linear biphasic theory are applied for the confined and unconfined compression of the cartilage. The fluid pressure and the elastic deformation of the biphasic cartilage are explicitly presented. The effective and equilibrium friction coefficients are obtained for the particular configuration of this bearing system. The micro-pockets geometrical parameters (depth, radius, surface distribution and edge radius) must be established to reduce the local contact stresses, to assure low friction forces and to minimize the biphasic cartilage damage. The influence of the applied pressure, porosity of the micro-pocket-covered component, filling time, cartilage elasticity, permeability and porosity upon the micro-pockets depth is illustrated. Our results are based upon the previously published data for a biphasic cartilage. [DOI: 10.1115/1.1589505]

Published
2003

27. Analysis of a torsional fluid film vibrator

Author

Suciu, C.V., Iwatsubo, T., and Pascovici, M.D.

Subjects
Fluid-film bearings -- Research, Hydrodynamics -- Research, Drilling and boring machinery -- Research, Science and technology
Abstract

A novel hydrodynamic system, called torsional fluid film vibrator (TFFV) is proposed. This device is complementary to the Lanchester's absorber and presents a classical response of a one-degree of freedom linear system with a periodical self-excitation. The fluid film thickness variation produces a variable viscous drag moment, which drives the elastically supported bush in a torsional oscillatory movement. The TFFV concept is connected with current research to improve the drilling technology of deep holes. The Navier-Stokes equations are solved on the particular geometry of this vibrator and the viscous drag moment is explicitly presented. The theoretical part is continued with the TFFV dynamic simulation and the analysis of the influence of the geometrical parameters on the amplitude of the viscous drag moment. Computed structural friction power and the amplitude of vibration agree reasonably well with the experimental measurements conducted on a TFFV test rig. [DOI: 10.1115/1.1454101]

Published
2002

35. Comparison of extent of tau pathology in patients with frontotemporal dementia with Parkinsonism linked to chromosome 17 (FTDP-17), frontotemporal lobar degeneration with Pick bodies and early onset Alzheimerʼs disease

Author

Shiarli, A.-M., Jennings, R., Shi, J., Bailey, K., Davidson, Y., Tian, J., Bigio, E. H., Ghetti, B., Murrell, J. R., Delisle, M. B., Mirra, S., Crain, B., Zolo, P., Arima, K., Iseki, E., Murayama, S., Kretzschmar, H., Neumann, M., Lippa, C., Halliday, G., MacKenzie, J., Khan, N., Ravid, R., Dickson, D., Wszolek, Z., Iwatsubo, T., Pickering-Brown, S. M., and Mann, D. M. A.

Published
2006

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