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Yvonne Bouter, Jose Socrates Lopez Noguerola, Petra Tucholla, Gabriela A N Crespi, Michael W Parker, Jens Wiltfang, Luke A Miles, Thomas A Bayer
No abstract text is available yet for this article.
March 25, 2024: Acta Neuropathologica
#2
Yue Qiao, Jian Gu, Miao Yu, Yuewei Chi, Ying Ma
BACKGROUND: Recent clinical trials of anti-Aβ monoclonal antibodies (mAbs) in the treatment of early Alzheimer's disease (AD) have produced encouraging cognitive and clinical results. The purpose of this network meta-analysis (NMA) was to compare and rank mAb drugs according to their efficacy and safety. METHODS: PubMed, Embase, Web of Science, and the Cochrane Library were searched for randomized controlled trials testing various mAbs for the treatment of cognitive decline in patients with AD, up to March 31, 2023...
March 2024: CNS Drugs
#3
REVIEW
Sheila A Doggrell
INTRODUCTION: There is no cure for Alzheimer's disease, which is the sixth leading cause of death in the U.S.A.. Lecanemab is anti-Aβ monoclonal antibody approved for the treatment of early Alzheimer's disease but is only marginally effective. Other antibodies are being developed including solanezumab. AREAS COVERED: A phase 3 clinical trial of solanezumab in preclinical Alzheimer's disease. In the A4 study, solanezumab did not reduce the decline in cognition or function and had no effect on brain amyloid burden...
February 27, 2024: Expert Opinion on Biological Therapy
#4
JOURNAL ARTICLE
Guoqiao Wang, Yan Li, Chengjie Xiong, Tammie L S Benzinger, Brian A Gordon, Jason Hassenstab, Andrew J Aschenbrenner, Eric McDade, David B Clifford, Jorge J Libre-Guerra, Xinyu Shi, Catherine J Mummery, Christopher H van Dyck, James J Lah, Lawrence S Honig, Gregg Day, John M Ringman, William S Brooks, Nick C Fox, Kazushi Suzuki, Johannes Levin, Mathias Jucker, Paul Delmar, Tobias Bittner, Randall J Bateman
INTRODUCTION: Increasing evidence suggests that amyloid reduction could serve as a plausible surrogate endpoint for clinical and cognitive efficacy. The double-blind phase 3 DIAN-TU-001 trial tested clinical and cognitive declines with increasing doses of solanezumab or gantenerumab. METHODS: We used latent class (LC) analysis on data from the Dominantly Inherited Alzheimer Network Trials Unit 001 trial to test amyloid positron emission tomography (PET) reduction as a potential surrogate biomarker...
February 23, 2024: Alzheimer's & Dementia: the Journal of the Alzheimer's Association
#5
REVIEW
Shubhrat Maheshwari, Aditya Singh, Vaseem Ahamad Ansari, Tarique Mahmood, Rufaida Wasim, Juber Akhtar, Amita Verma
The field of dementia research has witnessed significant developments in our understanding of neurodegenerative disorders, with a particular focus on Alzheimer's disease (AD) and Frontotemporal Dementia (FTD). Dementia, a collection of symptoms arising from the degeneration of brain cells, presents a significant healthcare challenge, especially as its prevalence escalates with age. This abstract delves into the complexities of these disorders, the role of biomarkers in their diagnosis and monitoring, as well as emerging neurophysiological insights...
February 2024: Ageing Research Reviews
#6
JOURNAL ARTICLE
Angélique Sadlon, Martin Ott, Reto W Kressig
INTRODUCTION: Patients who should benefit from anti-amyloid therapies (AAT) are found across all geriatric settings. Yet, it remains unclear how the use of AAT in patients with geriatric syndromes, such as frailty and polypharmacy, has so far been discussed in the literature. METHODS: Articles on aducanumab, gantenerumab, lecanemab, donanemab, crenezumab, solanezumab were retrieved in MEDLINE from inception to July 2023. For each article, identified geriatric relevant terms were assigned to five discussion contexts (eligibility of AAT study population, safety, prescription, patient clinical profile, alternative outcomes measurement)...
2023: Frontiers in Aging Neuroscience
#7
Dulin Wang, Xiaotian Ma, Paul E Schulz, Xiaoqian Jiang, Yejin Kim
Alzheimer's disease (AD) is a multifaceted neurodegenerative disorder with varied patient progression. We aim to test the hypothesis that AD patients can be categorized into subgroups based on differences in progression. We leveraged data from three randomized clinical trials (RCTs) to develop a knowledge-guided, deep temporal clustering (KG-DTC) framework for AD subtyping. This model combined autoencoders for contextual information capture, k-means clustering for representation formation, and clinical outcome classification for clinical knowledge integration...
October 13, 2023: medRxiv
#8
REVIEW
Kamran Shahid, Yonas Tamene, Shefali P Mody, Kaiser O Sadiq, Yogamba M Shivakumar, Eshwar Burra, Shivana Ramphall
Amyloid-ß (Aß) plaques and Neurofibrillary tangles are hallmarks of Alzheimer's disease (AD) pathology. Recent advances to find a cure for AD have led to the exploration of Anti-Aß monoclonal antibodies and angiotensin-receptor blockers (ARBs). The antibodies can decrease plaque formation or remove already formed plaques. ARBs increase angiotensin II (AT2) levels and decrease the effect of AT2 on the AT1 receptor (AT1R). This systematic analysis reviews evidence of monoclonal antibodies (Aducanumab, Lecanemab, Donanemab, and Solanezumab) and ARBs in managing AD...
August 2023: Curēus
#9
RANDOMIZED CONTROLLED TRIAL
Reisa A Sperling, Michael C Donohue, Rema Raman, Michael S Rafii, Keith Johnson, Colin L Masters, Christopher H van Dyck, Takeshi Iwatsubo, Gad A Marshall, Roy Yaari, Michele Mancini, Karen C Holdridge, Michael Case, John R Sims, Paul S Aisen
BACKGROUND: Trials of monoclonal antibodies that target various forms of amyloid at different stages of Alzheimer's disease have had mixed results. METHODS: We tested solanezumab, which targets monomeric amyloid, in a phase 3 trial involving persons with preclinical Alzheimer's disease. Persons 65 to 85 years of age with a global Clinical Dementia Rating score of 0 (range, 0 to 3, with 0 indicating no cognitive impairment and 3 severe dementia), a score on the Mini-Mental State Examination of 25 or more (range, 0 to 30, with lower scores indicating poorer cognition), and elevated brain amyloid levels on 18 F-florbetapir positron-emission tomography (PET) were enrolled...
September 21, 2023: New England Journal of Medicine
#10
REVIEW
Danko Jeremic, Juan D Navarro-López, Lydia Jiménez-Díaz
The risk-benefit profile of anti-Aβ monoclonal antibodies (mAbs) in Alzheimer's disease (AD) remains unclear, especially concerning their safety and overall effects on AD progression and cognitive function. Here, we investigated cognitive, biomarker and side effects of anti-Aβ mAbs in large phase III randomized placebo-controlled clinical trials (RCTs) in sporadic AD. The search was performed on Google Scholar, PubMed and ClinicalTrials.gov by applying Jadad score to evaluate the methodological quality of the reports...
September 2023: Ageing Research Reviews
#11
JOURNAL ARTICLE
Cynthia D Evans, JonDavid Sparks, Scott W Andersen, Dawn A Brooks, Paula M Hauck, Mark A Mintun, John R Sims
INTRODUCTION: Apolipoprotein E (APOE) ε4 may interact with response to amyloid-targeting therapies. METHODS: Aggregate data from trials enrolling participants with amyloid-positive, early symptomatic Alzheimer's disease (AD) were analyzed for disease progression. RESULTS: Pooled analysis of potentially efficacious antibodies lecanemab, aducanumab, solanezumab, and donanemab shows slightly better efficacy in APOE ε4 carriers than in non-carriers...
May 19, 2023: Alzheimer's & Dementia: the Journal of the Alzheimer's Association
#12
JOURNAL ARTICLE
Xing Fan, Lipeng Xu, Jianhao Zhang, Yidan Wang, Zirui Wu, Wenjing Sun, Xin Yao, Xu Wang, Shanshan Guan, Yaming Shan
Alzheimer's disease (AD) is a specific neurodegenerative disease. This study adopts single-chain variable fragments (scFvs) as a potential immunotherapeutic precursor for AD. According to the remarkable effects of monoclonal antibodies, such as the depolymerization or promotion of Aβ42 efflux by Crenezumab, Solanezumab, and 12B4, it is attractive to prepare corresponding scFvs targeting amyloid-β-42 protein (Aβ42) and investigate their biological activities. Crenezumab-like scFv (scFv-C), Solanezumab-like scFv (scFv-S), and 12B4-like scFv (scFv-12B4) were designed and constructed...
May 6, 2023: International Journal of Molecular Sciences
#13
JOURNAL ARTICLE
Karen C Holdridge, Roy Yaari, Deirdre B Hoban, Scott Andersen, John R Sims
INTRODUCTION: Solanezumab is a monoclonal antibody that binds to the mid-domain of soluble amyloid β peptide. This meta-analysis evaluated the effect of low-dose solanezumab on clinical progression in three phase 3 studies. METHODS: The population comprised patients aged ≥55 years with Alzheimer's disease (AD) with mild dementia, randomized to 400 mg solanezumab or placebo every 4 weeks for 80 weeks. Frequentist mixed-model repeated-measures (MMRM) and Bayesian disease progression model (DPM) longitudinal analyses were conducted...
October 2023: Alzheimer's & Dementia: the Journal of the Alzheimer's Association
#14
REVIEW
Bruno P Imbimbo, Viviana Triaca, Camillo Imbimbo, Robert Nisticò
We reviewed recent major clinical trials with investigational drugs for the treatment of subjects with neurodegenerative diseases caused by inheritance of gene mutations or associated with genetic risk factors. Specifically, we discussed randomized clinical trials in subjects with Alzheimer's disease, Huntington's disease and amyotrophic lateral sclerosis bearing pathogenic gene mutations, and glucocerebrosidase-associated Parkinson's disease. Learning potential lessons to improve future therapeutic approaches is the aim of this review...
August 2023: Neural Regeneration Research
#15
JOURNAL ARTICLE
Hugo Geerts, Mike Walker, Rachel Rose, Silke Bergeler, Piet H van der Graaf, Edgar Schuck, Akihiko Koyama, Sanae Yasuda, Ziad Hussein, Larisa Reyderman, Chad Swanson, Antonio Cabal
Antibody-mediated removal of aggregated β-amyloid (Aβ) is the current, most clinically advanced potential disease-modifying treatment approach for Alzheimer's disease. We describe a quantitative systems pharmacology (QSP) approach of the dynamics of Aβ monomers, oligomers, protofibrils, and plaque using a detailed microscopic model of Aβ40 and Aβ42 aggregation and clearance of aggregated Aβ by activated microglia cells, which is enhanced by the interaction of antibody-bound Aβ...
January 11, 2023: CPT: Pharmacometrics & Systems Pharmacology
#16
REVIEW
Michael Kunle Ajenikoko, Abayomi Oyeyemi Ajagbe, Oluwanisola Akanji Onigbinde, Akeem Ayodeji Okesina, Ahmad Adekilekun Tijani
Alzheimer's disease (AD) is the most common cause of dementia worldwide. Because Alzheimer's disease has no known treatment, sufferers and their caregivers must concentrate on symptom management. Astrocytes and microglia are now known to play distinct physiological roles in synaptic function, the blood-brain barrier, and neurovascular coupling. Consequently, the search for drugs that can slow the degenerative process in dementia sufferers continues because existing drugs are designed to alleviate the symptoms of Alzheimer's disease...
June 2023: IBRO neuroscience reports
#17
JOURNAL ARTICLE
Guoqiao Wang, Yan Li, Chengjie Xiong, Eric McDade, David B Clifford, Susan L Mills, Anna M Santacruz, Andrew J Aschenbrenner, Jason Hassenstab, Tammie L S Benzinger, Brian A Gordon, Anne M Fagan, Kelley A Coalier, Jorge J Libre-Guerra, Austin McCullough, Nelly Joseph-Mathurin, Charles D Chen, Catherine Mummery, Barbara A Wendelberger, Serge Gauthier, Mario Masellis, Karen C Holdridge, Roy Yaari, Saptarshi Chatterjee, John Sims, Paul Delmar, Geoffrey A Kerchner, Tobias Bittner, Carsten Hofmann, Randall J Bateman
Introduction: While the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) was ongoing, external data suggested higher doses were needed to achieve targeted effects; therefore, doses of gantenerumab were increased 5-fold, and solanezumab was increased 4-fold. We evaluated to what extent mid-trial dose increases produced a dose-dependent treatment effect. Methods: Using generalized linear mixed effects (LME) models, we estimated the annual low- and high-dose treatment effects in clinical, cognitive, and biomarker outcomes...
2022: Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring
#18
JOURNAL ARTICLE
Vidya Ramakrishnan, Christina Friedrich, Colleen Witt, Robert Sheehan, Meghan Pryor, Jasvinder K Atwal, Kristin Wildsmith, Katherine Kudrycki, Seung-Hye Lee, Norman Mazer, Carsten Hofmann, Reina N Fuji, Jin Y Jin, Saroja Ramanujan, Michael Dolton, Angelica Quartino
Despite considerable investment into potential therapeutic approaches for Alzheimer's disease (AD), currently approved treatment options are limited. Predictive modeling using quantitative systems pharmacology (QSP) can be used to guide the design of clinical trials in AD. This study developed a QSP model representing beta-amyloid (Aβ) pathophysiology in AD. The model included mechanisms of Aβ monomer production and aggregation to form insoluble fibrils and plaques; the transport of soluble species between the compartments of brain, cerebrospinal fluid (CSF), and plasma; and the pharmacokinetics, transport, and binding of monoclonal antibodies to targets in the 3 compartments...
October 24, 2022: CPT: Pharmacometrics & Systems Pharmacology
#19
JOURNAL ARTICLE
Nelly Joseph-Mathurin, Jorge J Llibre-Guerra, Yan Li, Austin A McCullough, Carsten Hofmann, Jakub Wojtowicz, Ethan Park, Guoqiao Wang, Gregory M Preboske, Qing Wang, Brian A Gordon, Charles D Chen, Shaney Flores, Neelum T Aggarwal, Sarah B Berman, Thomas D Bird, Sandra E Black, Bret Borowski, William S Brooks, Jasmeer P Chhatwal, Roger Clarnette, Carlos Cruchaga, Anne M Fagan, Martin Farlow, Nick C Fox, Serge Gauthier, Jason Hassenstab, Diana A Hobbs, Karen C Holdridge, Lawrence S Honig, Russ C Hornbeck, Ging-Yuek R Hsiung, Clifford R Jack, Ivonne Z Jimenez-Velazquez, Mathias Jucker, Gregory Klein, Johannes Levin, Michele Mancini, Mario Masellis, Nicole S McKay, Catherine J Mummery, John M Ringman, Hiroyuki Shimada, B Joy Snider, Kazushi Suzuki, David Wallon, Chengjie Xiong, Roy Yaari, Eric McDade, Richard J Perrin, Randall J Bateman, Stephen P Salloway, Tammie L S Benzinger, David B Clifford
OBJECTIVE: To determine the characteristics of participants with amyloid-related imaging abnormalities (ARIA) in a trial of gantenerumab or solanezumab in dominantly inherited Alzheimer disease (DIAD). METHODS: 142 DIAD mutation carriers received either gantenerumab SC (n = 52), solanezumab IV (n = 50), or placebo (n = 40). Participants underwent assessments with the Clinical Dementia Rating® (CDR®), neuropsychological testing, CSF biomarkers, β-amyloid positron emission tomography (PET), and magnetic resonance imaging (MRI) to monitor ARIA...
November 2022: Annals of Neurology
#20
JOURNAL ARTICLE
Diana Otero Svaldi, Ixavier A Higgins, Karen C Holdridge, Roy Yaari, Michael Case, Luc Bracoud, David Scott, Sergey Shcherbinin, John R Sims
Introduction: Solanezumab is a monoclonal antibody that preferentially binds soluble amyloid beta and promotes its clearance from the brain. The aim of this post hoc analysis was to assess the effect of low-dose solanezumab (400 mg) on global brain volume measures in patients with mild or moderate Alzheimer's disease (AD) dementia quantified using volumetric magnetic resonance imaging (vMRI) data from the EXPEDITION clinical trial program. Methods: Patients with mild or moderate AD (EXPEDITION and EXPEDITION2) and mild AD (EXPEDITION3), were treated with either placebo or solanezumab (400 mg) every 4 weeks (Q4W) for 76 weeks...
2022: Alzheimer's & Dementia: Translational Research & Clinical Interventions
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