crenezumab (RG7412) / AC Immune 
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 9 Diseases   1 Trial   1 Trial   304 News 


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  • ||||||||||  ACU193 / Acumen Pharma
    Clinical, Review, Journal:  ACU193: An Immunotherapeutic Poised to Test the Amyloid β Oligomer Hypothesis of Alzheimer's Disease. (Pubmed Central) -  May 14, 2022   
    More than 25 negative randomized clinical trials (RCTs) have evaluated Aβ-targeting therapeutics, yet none has directly evaluated whether selective blockage of disease-relevant AβOs can stop or reverse AD-associated cognitive decline. Here, we briefly summarize studies that establish the AD therapeutic rationale to target AβOs selectively, and we describe ACU193, the first AβO-selective immunotherapeutic to enter human clinical trials and the first positioned to test the AβO hypothesis of AD.
  • ||||||||||  bapineuzumab (AAB-001) / Pfizer, J&J, Perrigo Company, crenezumab (MABT5102A) / Roche
    Journal, Heterogeneity:  N-terminal heterogeneity of parenchymal and vascular amyloid-β deposits in Alzheimer's disease. (Pubmed Central) -  Oct 30, 2021   
    This suggests conformational preferences of this antibody. The diverse composition of plaques and vascular deposits stresses the importance of understanding the roles of various Aβ variants during disease development and progression in order to generate appropriate target-developed therapies.
  • ||||||||||  Aduhelm (aducanumab) / Eisai, Biogen, crenezumab (MABT5102A) / Roche
    Journal:  Rational affinity maturation of anti-amyloid antibodies with high conformational and sequence specificity. (Pubmed Central) -  Aug 22, 2021   
    Notably, the affinity-maturated antibodies display extremely low levels of non-specific interactions, as observed for crenezumab and unlike aducanumab. We expect that our systematic methods for generating antibodies with unique combinations of desirable properties will improve the generation of high-quality conformational antibodies specific for diverse types of aggregated conformers.
  • ||||||||||  crenezumab (MABT5102A) / Roche, semorinemab (RG6100) / Roche
    Comparison of the FCSRT and RBANS in screening for early AD clinical trials: Enrichment for disease progression () -  Aug 7, 2021 - Abstract #CTAD2021CTAD_95;    
    P2, P3
    Our results suggest that both of these episodic memory assessments yield comparable enrichment for participants likely to demonstrate clinical progression over this interval. The choice of specific episodic memory tests for inclusion in future early AD studies may be influenced by study design considerations beyond enrichment for participants at highest risk for subsequent cognitive decline.
  • ||||||||||  crenezumab (MABT5102A) / Roche, solanezumab (LY2062430) / Eli Lilly
    Journal:  Mechanistic Modeling of Soluble Aβ Dynamics and Target Engagement in the Brain by Anti-Aβ mAbs in Alzheimer's Disease. (Pubmed Central) -  Aug 6, 2021   
    This model is useful for comparing target engagement profiles of different anti-Aβ therapies and demonstrates that 60 mg/kg crenezumab yields a significant increase in Aβ engagement compared with lower doses of solanezumab, supporting the selection of 60 mg/kg crenezumab for phase 3 studies. The model also provides evidence that delivery of sufficient quantities of mAb to brain interstitial fluid is a limiting step with respect to the magnitude of soluble Aβ oligomer neutralization.
  • ||||||||||  Review, Journal:  Critical Appraisal of Amyloid Lowering Agents in AD. (Pubmed Central) -  Jun 30, 2021   
    Future directions for improving the treatment of AD will include more inquiry into the efficacy of mAbs as disease-modifying agents that specifically target Aβ peptides and/or multimers. In addition, a more robust trial design for AD immunotherapy agents should improve outcomes such that objective measures of clinical efficacy will eventually lead to higher chances of drug approval.
  • ||||||||||  gantenerumab (RG1450) / Roche, MorphoSys, crenezumab (MABT5102A) / Roche, solanezumab (LY2062430) / Eli Lilly
    Review, Journal:  Can Anti-β-amyloid Monoclonal Antibodies Work in Autosomal Dominant Alzheimer Disease? (Pubmed Central) -  Feb 13, 2021   
    Surprisingly, solanezumab significantly accelerated cognitive decline of both asymptomatic and symptomatic subjects. These failures further undermine the Aβ hypothesis and could support the suggestion that ADAD is triggered by accumulation of other APP metabolites, rather than Aβ.
  • ||||||||||  Journal, IO biomarker:  Passive antiamyloid immunotherapy for Alzheimer's disease. (Pubmed Central) -  Feb 2, 2021   
    The high incidence of ARIAs indicates that the risk of adverse events may outweigh the benefits of these interventions. Ongoing studies must determine the benefit of such interventions in preclinical Alzheimer's disease, addressing the effect of antiamyloid immunotherapy in samples of asymptomatic carriers of autosomal-dominant mutations related to early-onset Alzheimer's disease.
  • ||||||||||  [VIRTUAL] BENCHMARKING DISEASE MODIFYING THERAPIES FOR ALZHEIMER’S DISEASE USING A QUANTITATIVE SYSTEMS PHARMACOLOGY MODEL (On Demand Symposia E) -  Dec 24, 2020 - Abstract #ADPD2021ADPD_842;    
    The model is positioned for simulation-based analysis of tau targeting antibodies and their effect on biomarker engagement and dynamics in brain, CSF, and plasma.  Conclusions The model serves as a tool for simulation-based quantitative assessment of target engagement and biomarker dynamics by disease-modifying therapies in the brain and CSF. The model provides a comprehensive platform to test scientific hypothesis related to target and biomarker dynamics.
  • ||||||||||  crenezumab (MABT5102A) / Roche
    Preclinical, Journal:  Characterization of the selective in vitro and in vivo binding properties of crenezumab to oligomeric Aβ. (Pubmed Central) -  Aug 7, 2020   
    Crenezumab binds to multiple forms of amyloid β (Aβ), particularly oligomeric forms, and localizes to brain areas rich in Aβ oligomers, including the halo around plaques and hippocampal mossy fibers, but not to vascular Aβ. These insights highlight a unique mechanism of action for crenezumab of engaging Aβ oligomers.
  • ||||||||||  crenezumab (MABT5102A) / Roche
    Trial termination:  CREAD OLE: An Open-Label Crenezumab Study in Participants With Alzheimer's Disease (clinicaltrials.gov) -  Jul 13, 2020   
    P3,  N=149, Terminated, 
    Completed --> Terminated; This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint. Completed --> Terminated; This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint.
  • ||||||||||  aducanumab (BIIB037) / Eisai, Biogen, crenezumab (MABT5102A) / Roche, solanezumab (LY2062430) / Eli Lilly
    Review, Journal:  Pathways Connecting Late-Life Depression and Dementia. (Pubmed Central) -  Apr 2, 2020   
    The tau hypothesis, sex/gender specific differences, epigenetics and the gut microbiota-brain axis imply other potential common pathways connecting late-life depression and dementia. In conclusion, different potential pathophysiological links between dementia and depression highlight several specific synergistic and multifaceted treatment possibilities, depending on the individual risk profile of the patient.
  • ||||||||||  crenezumab (MABT5102A) / Roche
    Biomarker, Journal:  Target Engagement in an Alzheimer Trial: Crenezumab Lowers Aβ Oligomers in CSF. (Pubmed Central) -  Mar 31, 2020   
    Crenezumab lowered CSF oAβ levels in the large majority of treated patients tested. These results support engagement of the principal pathobiological target in AD and identify CSF oAβ as a novel pharmacodynamic biomarker for use in trials of anti-Aβ agents.
  • ||||||||||  crenezumab (MABT5102A) / Roche
    Journal:  The Value of Pre-Screening in the Alzheimer's Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease Trial. (Pubmed Central) -  Nov 15, 2019   
    The Alzheimer's Prevention Initiative (API) Autosomal Dominant Alzheimer's Disease (ADAD) trial evaluates the anti-amyloid-β antibody crenezumab in cognitively unimpaired persons who, based on genetic background and age, are at high imminent risk of clinical progression, and provides a powerful test of the amyloid hypothesis...With the Colombian API Registry and our prescreening efforts, we randomized 169 30-60 year-old cognitively unimpaired carriers and 83 non-carriers who agreed to participate in the trial for at least 60 months. Our findings suggest multiple benefits of implementing a pre-screening process for enrolling prevention trials in ADAD.
  • ||||||||||  crenezumab (MABT5102A) / Roche
    Clinical, P2 data, Journal:  ABBY: A phase 2 randomized trial of crenezumab in mild to moderate Alzheimer disease. (Pubmed Central) -  Aug 15, 2019   
    Although prespecified criteria for testing treatment effects were not met, these data suggest a potential treatment effect in patients with mild AD treated with high-dose crenezumab. Together with the safety profile for crenezumab, these data support the exploration of crenezumab treatment at even higher doses in patients with early AD.
  • ||||||||||  crenezumab (MABT5102A) / Roche
    Trial completion:  CREAD OLE: An Open-Label Crenezumab Study in Participants With Alzheimer's Disease (clinicaltrials.gov) -  Jul 30, 2019   
    P3,  N=149, Completed, 
    Together with the safety profile for crenezumab, these data support the exploration of crenezumab treatment at even higher doses in patients with early AD. Active, not recruiting --> Completed
  • ||||||||||  crenezumab (MABT5102A) / Roche
    Trial completion date, Trial primary completion date:  CREAD OLE: An Open-Label Crenezumab Study in Participants With Alzheimer's Disease (clinicaltrials.gov) -  Mar 19, 2019   
    P3,  N=1500, Recruiting, 
    Trial completion date: Oct 2022 --> May 2019 | Trial primary completion date: Oct 2021 --> May 2019 Trial completion date: Nov 2022 --> May 2019 | Trial primary completion date: Nov 2022 --> May 2019