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


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  • ||||||||||  Review, Journal:  Engineered Antibodies to Improve Efficacy against Neurodegenerative Disorders. (Pubmed Central) -  Jun 27, 2024   
    The identified products can be readily tested and returned to patients with the lowest regulatory cost and delays. These engineered antibodies can be manufactured by recombinant engineering, preferably by mRNA technology, as a more affordable solution to meet the dire need to treat neurodegenerative disorders effectively.
  • ||||||||||  Review, Journal:  Alzheimer's disease and clinical trials. (Pubmed Central) -  Apr 1, 2024   
    A meticulous prior assessment of the outcome of clinical studies may stop risky clinical trials at their inceptions. This may save time, money, and resources.
  • ||||||||||  crenezumab (RG7412) / Roche
    Journal:  Re-Engineering Therapeutic Anti-A? Monoclonal Antibody to Target Amyloid Light Chain. (Pubmed Central) -  Feb 14, 2024   
    antibody, is currently unsuccessful, we chose it as a model to computationally design and prepare crenezumab variants, aiming to discover a novel antibody with high affinity to AL fibrils and to establish a technology platform for repurposing amyloid monoclonal antibodies...It is capable of reversing A?42-oligomers-induced cytotoxicity, decreasing the formation of AL fibrils, and alleviating AL-fibrils-induced cytotoxicity in vitro. Our research demonstrated that an amyloid antibody could be engineered by a few mutations to bind new amyloid sequences, providing an efficient way to reposition a therapeutic antibody to target different amyloid diseases.
  • ||||||||||  Observations on biomarkers in Roche Abeta-targeting monoclonal antibody trials (Hall 5) -  Jul 6, 2023 - Abstract #AAIC2023AAIC_9021;    
    P2, P2/3,
    Biomarker results in the phase III GRADUATE I and II (NCT03444870 and NCT03443973) trials with gantenerumab in early AD (sporadic) also suggest that even moderate reduction of beta-amyloid plaques may not result in clinically meaningful benefits over a therapeutic time course that makes sense for patients , while the phase III CLARITY-AD trial (NCT01767311) with lecanemab and phase III TRAILBLAZER-ALZ 2 trial (NCT04437511) with donanemab suggest that enough reduction can cross the threshold for clinical efficacy. This observation, if confirmed, would not rule out the use of beta amyloid lowering therapies that do not completely clear beta amyloid when used in combination approaches.
  • ||||||||||  crenezumab (RG7412) / Roche
    Contraception in Female Volunteer in Alzheimer (In-Person) -  Jul 6, 2023 - Abstract #AAIC2023AAIC_2463;    
    Funding: NIA grants RF1-AG041705, R01-AG055444, Genentech, Roche, philanthropic contributions to Banner Alzheimer According the p-value obtained to compare the GFR between trial volunteers and the Colombian population, the strategies used to address contraception by the site were effective for the prevention of pregnancies.
  • ||||||||||  crenezumab (MABT5102A) / Roche
    Journal:  Longitudinal Exposure-Response Modeling of Multiple Indicators of Alzheimer's Disease Progression. (Pubmed Central) -  Mar 25, 2023   
    P2
    These models are not intended to support causal inferences, but they do successfully characterize the observed correlation between endpoints over time and result in concise numerical indices of disease status that reflect the totality of evidence from considering the endpoints jointly. As such, the models have utility for a variety of tasks in clinical trial design, including simulation of hypothetical drug effects, interpolation of missing data, and assessment of in-sample information.
  • ||||||||||  Clinical, Review, Journal:  Investigational treatments for neurodegenerative diseases caused by inheritance of gene mutations: lessons from recent clinical trials. (Pubmed Central) -  Feb 8, 2023   
    A trial of venglustat, a potent and brain-penetrant glucosylceramide synthase inhibitor, in Parkinson's disease subjects with heterozygous glucocerebrosidase gene mutations revealed worsened clinical and cognitive performance of patients on the enzyme inhibitor compared to placebo. We concluded that clinical trials in neurodegenerative diseases with a genetic basis should test monoclonal antibodies, antisense oligonucleotides or gene editing directed against the mutated enzyme or the mutated substrate without dramatically affecting physiological wild-type variants.
  • ||||||||||  Journal:  A combined PBPK and QSP model for modeling amyloid aggregation in Alzheimer's Disease. (Pubmed Central) -  Jan 13, 2023   
    ARIA-E is well predicted for all antibodies except bapineuzumab. This QSP model could support clinical trial design of different amyloid modulating interventions, define optimal titration and maintenance schedules and provide a first step to understand the variability of biomarker response in clinical practice.
  • ||||||||||  crenezumab (MABT5102A) / Roche
    Journal:  A public resource of baseline data from the Alzheimer's Prevention Initiative Autosomal-Dominant Alzheimer's Disease Trial. (Pubmed Central) -  Nov 15, 2022   
    Baseline data are publicly available; treatment data and biological samples, including baseline and treatment-related blood-based biomarker data will become available in accordance with our original trial agreement and subsequently developed Collaboration for Alzheimer's Prevention principles. Sharing of these data will allow exploration of important questions including the differential effects of initiating an investigational AD prevention therapy both before as well as after measurable Aβ plaque deposition.
  • ||||||||||  crenezumab (MABT5102A) / Roche
    Plasma Biomarker Findings from the Alzheimer’s Prevention Initiative Autosomal Dominant Alzheimer’s Disease Colombia Trial (Grand Ballroom AB - Tower 2) -  Oct 5, 2022 - Abstract #CTAD2022CTAD_281;    
    P2
    This model may facilitate the design of scientifically enriched and efficient clinical trials by enabling a priori prediction of biomarker dynamics in the brain and CSF. The API ADAD Colombia Trial was intended to characterize the efficacy, safety, and tolerability of crenezumab in the prevention of AD; explore the treatment’s differential biomarker effects in amyloid-positive and amyloid-negative participants at virtually certain AD risk; clarify relationships between the treatment effects on biomarker and clinical outcomes; provide a shared resource of data and samples for the field; help to establish a new era in AD prevention research; and advance the role of emerging BBBMs in these endeavors.