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- tilavonemab (ABBV-8E12) / AbbVie
APPLICATIONS OF DIGITAL TWINS OF ALZHEIMER (Hall F2) - Mar 10, 2025 - Abstract #ADPD2025ADPD_661;
P2
The trained AD model generated digital twins of participants post-hoc using the baseline data of participants enrolled in a completed phase 2 trial (AWARE trial, N=453, NCT02880956), which tested tilavonemab, an anti-tau monoclonal antibody, in subjects with early AD...Conclusions Digital twins can be seamlessly integrated into AD studies to enhance efficiency in the design and conduct while remaining aligned with regulatory guidance. Furthermore, digital twins increase confidence in decision-making during the trial.
- | tilavonemab (ABBV-8E12) / AbbVie
Journal: Drug Development. (Pubmed Central) - Jan 12, 2025
P2
ADAS-Cog 14 in the AWARE study. Sample size savings could enable shortening of the recruitment period and reduce the number of patients on placebo, encouraging greater patient participation.
- | tilavonemab (ABBV-8E12) / AbbVie
Journal: Proteostasis as a fundamental principle of Tau immunotherapy. (Pubmed Central) - Jan 8, 2025
Therefore, by phage display, we generated a novel pan-Tau antibody, RNJ1, that preferentially binds human Tau and neutralizes proteopathic seeding activity in multiple cell lines and benchmarked it against a clinically tested pan-Tau antibody, HJ8.5 (murine version of tilavonemab)...Gene set over-representation analysis (ORA) further confirmed that proteins undergoing restoration are involved in biological pathways affected in K3 mice. Together, our study suggests that a Tau immunotherapy-induced restoration of proteostasis links target engagement and treatment efficacy.
- | tilavonemab (ABBV-8E12) / AbbVie
Journal: Efficiency of multivariate tests in trials in progressive supranuclear palsy. (Pubmed Central) - Oct 27, 2024
We assess the performance of these tests under various scenarios in an extensive simulation study and illustrate their use with a re-analysis of the ABBV-8E12 clinical trial...The efficiency of the PSPRS sum score, while generally robust and straightforward to apply, varies depending on the specific patterns of effect sizes encountered and more powerful alternatives are available in specific settings. These findings can have important implications for the design of future clinical trials in PSP and similar multifaceted diseases.
- tilavonemab (ABBV-8E12) / AbbVie
Language impairment associated with prognosis in progressive supranuclear palsy (Exhibit (Pennsylvania Convention Center); In-Person) - Jun 19, 2024 - Abstract #AAIC2024AAIC_3065;
Atrophy in language areas at baseline predicted language decline. Language impairment may be an independent prognostic factor in PSP.
- tilavonemab (ABBV-8E12) / AbbVie
Assessment of AI-generated digital twin (DT) methodology on reduction of treatment effect variance and potential clinical trial sample size saving using a Phase 2 trial dataset from patients with Alzheimer (Exhibit (Pennsylvania Convention Center); In-Person) - Jun 19, 2024 - Abstract #AAIC2024AAIC_2504;
P2
We assessed these properties using data from a Phase 2 clinical trial of tilavonemab in patients diagnosed with early AD (NCT02880956) and digital twin (DT) methodology (PROCOVA TM )... Depending on correlations between prognostic scores and actual trial outcomes, a potential overall sample size reduction of 5
- | tilavonemab (ABBV-8E12) / AbbVie
Journal: Assessing tilavonemab efficacy in early Alzheimer's disease via longitudinal item response theory modeling. (Pubmed Central) - Jun 5, 2024
Depending on correlations between prognostic scores and actual trial outcomes, a potential overall sample size reduction of 5 While tilavonemab failed to mitigate impairment progression, our multidimensional IRT analysis illuminated the interconnected progression of cognitive and functional declines in AD, suggesting a comprehensive perspective on disease trajectories.
- | Journal: Analysis of clinical failure of anti-tau and anti-synuclein antibodies in neurodegeneration using a quantitative systems pharmacology model. (Pubmed Central) - Sep 7, 2023
The study generates optimal values of selectivity, sensitivity and PK profiles for antibodies. The study identifies a gradient of decreasing target engagement from CSF to the synaptic cleft as a key driver of efficacy, quantitatively identifies various improvements for drug design and emphasizes the need for QSP modelling to support the development of tau and aSyn antibodies.
- tilavonemab (ABBV-8E12) / AbbVie
A tau-directed monoclonal antibody could alter the tau pathology of progressive supranuclear palsy () - Aug 30, 2023 - Abstract #MDSCongress2023MDS_Congress_679;
The study identifies a gradient of decreasing target engagement from CSF to the synaptic cleft as a key driver of efficacy, quantitatively identifies various improvements for drug design and emphasizes the need for QSP modelling to support the development of tau and aSyn antibodies. Our study suggests that a tau-directed monoclonal antibody could alter the tau pathology of PSP and might promote microglia/macrophage-mediated phagocytosis.
- tilavonemab (ABBV-8E12) / AbbVie
A polygenic risk score (PRS) predicts cognitive decline in the APOE3 population in an early Alzheimer (In-Person) - Jul 6, 2023 - Abstract #AAIC2023AAIC_8476;
Our study suggests that a tau-directed monoclonal antibody could alter the tau pathology of PSP and might promote microglia/macrophage-mediated phagocytosis. We utilized PRS ( geno SCORE
- ||||| tilavonemab (ABBV-8E12) / AbbVie
Clinical: #Tilavonemab in early Alzheimer’s: results from a phase 2, randomized, double-blind study https://t.co/lbvhQfwBNB Failure in AD follows similar disappointing results in #progressive supranuclear palsy. A sobering but definitive conclusion from the authors @AlbertoEspay 👇 (Twitter) - Mar 3, 2023
- || tilavonemab (ABBV-8E12) / AbbVie
Clinical, P2 data, Journal: Tilavonemab in early Alzheimer's disease: results from a phase 2, randomized, double-blind study. (Pubmed Central) - Feb 3, 2023
P2
The incidence of any adverse event and MRI findings were generally comparable across groups.Tilavonemab was generally well tolerated but did not demonstrate efficacy in treating patients with early Alzheimer's disease. Further investigations of tilavonemab in early Alzheimer's disease are not warranted.
- tilavonemab (ABBV-8E12) / AbbVie
VISUAL ASSESSMENT OF [18F]MK-6240 PET SCANS IN EARLY ALZHEIMER'S DISEASE (EXHIBITION) - Dec 23, 2022 - Abstract #ADPD2023ADPD_2240;
Our visual assessment of [18F]MK -6240 PET scans showed good agreement between readers. The use of a novel extent score may allow us to select AD patients by Braak stage using solely a visual read.
- MODELING PHARMACODYNAMIC EFFECTS OF PUBLISHED CLINICALLY TESTED ANTI-TAU AND ANTISYNUCLEIN ANTIBODIES TO IMPROVE CLINICAL TRIAL DESIGN (On-Demand Oral Gallery B) - Dec 23, 2022 - Abstract #ADPD2023ADPD_1069;
We si mulated clinical trials of gosuranemab, tilavonemab, semorinemab, cinpanemab and prasinezumab using published clinical profiles. The current model suggests that the antibodies' effect on accessible biomarkers in CSF is quite different from changes in other brain compa rtments, notably in the synaptic cleft and neuronal uptake which are proxies for disease progression.
- |||||| tilavonemab (ABBV-8E12) / AbbVie
Trial termination: An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD) (clinicaltrials.gov) - Sep 22, 2022
P2, N=364, Terminated, Sponsor: AbbVie
The current model suggests that the antibodies' effect on accessible biomarkers in CSF is quite different from changes in other brain compa rtments, notably in the synaptic cleft and neuronal uptake which are proxies for disease progression. Completed --> Terminated; Discontinued because of lack of efficacy in the parent study (Study M15-566; NCT02880956).
- || (2/4) Are more studies needed? Semorinemab is the fourth anti-tau treatment to come and go, after zagotenemab, ABBV-8E12, and gosuranemab. These interventions lower tau, as designed. They just do not improve symptoms. (Twitter) - Jun 14, 2022
- |||| tilavonemab (ABBV-8E12) / AbbVie
Trial completion: An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD) (clinicaltrials.gov) - Nov 16, 2021
P2, N=364, Completed, Sponsor: AbbVie
Completed --> Terminated; Discontinued because of lack of efficacy in the parent study (Study M15-566; NCT02880956). Active, not recruiting --> Completed
- | tilavonemab (ABBV-8E12) / AbbVie
Journal: Neuropathology of progressive supranuclear palsy after treatment with tilavonemab. (Pubmed Central) - Sep 30, 2021
Active, not recruiting --> Completed No abstract available
- | tilavonemab (ABBV-8E12) / AbbVie
Journal: Neuropathology of progressive supranuclear palsy after treatment with tilavonemab - Author's reply. (Pubmed Central) - Sep 30, 2021
No abstract available No abstract available
- tilavonemab (ABBV-8E12) / AbbVie
Phase 2 Study of Tilavonemab, an Anti-tau Antibody, in Early Alzheimer’s Disease () - Aug 7, 2021 - Abstract #CTAD2021CTAD_88;
P2
No abstract available Although generally safe and well tolerated among patients in the study, tilavonemab did not demonstrate efficacy in treating patients with early AD.
- tilavonemab (ABBV-8E12) / AbbVie
Characteristics of subjects with discordant amyloid status between visual read and centiloid from the Phase 2 clinical study of Tilavonemab in early Alzheimer’s disease (Ballroom) - Aug 7, 2021 - Abstract #CTAD2021CTAD_27;
P2
Visually-negative CL-positive amyloid patients had a significantly lower mean CL value than visually-positive (randomized) patients and were significantly less impaired as measured by MMSE and CDR-SB. Using a quantitative threshold (CL) as an inclusion criterion appears to be a valid strategy but is more sensitive to lower levels of amyloid, which may result in an earlier or less impaired AD population.
- tilavonemab (ABBV-8E12) / AbbVie
[VIRTUAL] Baseline amyloid and tau PET imaging characteristics in the ongoing phase 2 study of tilavonemab in early Alzheimer’s disease () - Aug 2, 2021 - Abstract #AAIC2021AAIC_2799;
This analysis confirmed the presence of amyloid pathology in the patients randomized into the trial and suggested a high proportion of patients have tau pathology in the brain. Future analyses will examine how tilavonemab effects tau pathology.
- |||| tilavonemab (ABBV-8E12) / AbbVie
Trial completion: A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - Jul 8, 2021
P2, N=453, Completed, Sponsor: AbbVie
Future analyses will examine how tilavonemab effects tau pathology. Active, not recruiting --> Completed
- ||| tilavonemab (ABBV-8E12) / AbbVie
Enrollment closed, Trial completion date, Trial primary completion date: An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD) (clinicaltrials.gov) - Jun 10, 2021
P2, N=364, Active, not recruiting, Sponsor: AbbVie
Active, not recruiting --> Completed Enrolling by invitation --> Active, not recruiting | Trial completion date: Jul 2026 --> Jul 2021 | Trial primary completion date: Jul 2026 --> Jul 2021
- || donepezil / Generic mfg., galantamine hydrobromide / Generic mfg., memantine / Generic mfg.
Review, Journal: Alzheimer's disease: Recent treatment strategies. (Pubmed Central) - May 15, 2021
Current treatment for AD (donepezil, galantamine, rivastigmine and memantine) is only symptomatic and has modest benefits...Even the positive findings presented by Biogen on Aducanumab are not entirely clear and further data is necessary to confirm its validity...Four monoclonal antibodies anti-tau (Gosuranemab, Tilavonemab, Semorinemab and Zagotenemab) and one anti-tau vaccine (AADvac1) have reached phase II, so far. In this review, we discuss the potential disease-modifying agents tested in clinical trials and update the information of drugs that are still under clinical evaluation.
- | gosuranemab (BIIB092) / Biogen, bepranemab (UCB0107) / UCB, Roche, tilavonemab (ABBV-8E12) / AbbVie
Journal: Immunotherapy in progressive supranuclear palsy. (Pubmed Central) - May 4, 2021
The likely role of extracellular tau in the progression of PSP makes tau a natural target for targeted immunotherapy. Clinical trials are still in early stages, and although tau immunotherapy has largely been shown to be safe, efficacy has yet to be demonstrated.
- || tilavonemab (ABBV-8E12) / AbbVie
Clinical, P2 data, Journal: Safety and efficacy of tilavonemab in progressive supranuclear palsy: a phase 2, randomised, placebo-controlled trial. (Pubmed Central) - Mar 5, 2021
P2
No beneficial treatment effects were recorded. Although this study did not provide evidence of efficacy in progressive supranuclear palsy, the findings provide potentially useful information for future investigations of passive immunisation using tau antibodies for progressive supranuclear palsy.
- || tilavonemab (ABBV-8E12) / AbbVie
(7/9) Instead what explanations do the authors offer? 1.Extracellular tau may not be “key to progression.” 2.“tilavonemab might not target the specific tau species that drives spreading of pathology” 3.“not enough tilavonemab enters the CNS to elicit a therapeutic effect” (Twitter) - Feb 21, 2021
- || tilavonemab (ABBV-8E12) / AbbVie
(6/9) So, tilavonemab doses reached the brain, binding to the target by lowering the CSF concentration of free tau. The results suggest the hypothesis of tau toxicity is wrong. Yet, the investigators cannot dare to conclude that. (Twitter) - Feb 21, 2021
- |||| tilavonemab (ABBV-8E12) / AbbVie
Clinical: (5/9) What about brain volume? The trend here was also in the opposite direction to that hypothesized: compared with placebo, the LSM difference was –7.2 mm³ for tilavonemab 2000 mg and –6.3 mm³ for tilavonemab 4000 mg. At the midbrain level, there were no differences. (Twitter) - Feb 21, 2021
- ||| tilavonemab (ABBV-8E12) / AbbVie
Clinical: (2/9) This futility-terminated Ph 2 double-blind, placebo-controlled trial randomly assigned 378 PSP patients to placebo, tilavonemab 2000 mg, or tilavonemab 4000 mg, infused on days 1, 15, and 29, and every 28 days throughout the 52-week study. Main endpoint: PSPRS total score. (Twitter) - Feb 21, 2021
- |||| tilavonemab (ABBV-8E12) / AbbVie
Clinical: The clinical trial of tilavonemab for #PSP_ProgressiveSupranuclearPalsy offers definitive proof that the anti-tau strategy is wrong. A cautionary tale, also for #Alzheimers, in 9 parts (thread). https://t.co/ECFJMN9xaw (Twitter) - Feb 21, 2021
- ||||| tilavonemab (ABBV-8E12) / AbbVie
Trial termination: An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP) (clinicaltrials.gov) - Feb 2, 2021
P2, N=142, Terminated, Sponsor: AbbVie
Although this study did not provide evidence of efficacy in progressive supranuclear palsy, the findings provide potentially useful information for future investigations of passive immunisation using tau antibodies for progressive supranuclear palsy. Completed --> Terminated; This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy.
- |||||| tilavonemab (ABBV-8E12) / AbbVie
Trial termination: A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP) (clinicaltrials.gov) - Feb 2, 2021
P2, N=378, Terminated, Sponsor: AbbVie
Completed --> Terminated; This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy. Completed --> Terminated; This study was prematurely discontinued because the program for progressive supranuclear palsy was discontinued due to lack of efficacy of study drug.
- tilavonemab (ABBV-8E12) / AbbVie
[VIRTUAL] PHASE 2 STUDY OF TILAVONEMAB, AN ANTI-TAU ANTIBODY, IN EARLY ALZHEIMER’S DISEASE: STUDY DESIGN, BASELINE DEMOGRAPHICS, AND BIOMARKER PROFILES DESIGN, BASELINE DEMOGRAPHICS, AND BIOMARKER PROFILES () - Aug 7, 2020 - Abstract #CTAD2020CTAD_10;
P2
At baseline, patients in this study exhibit slightly higher levels of CSF amyloid and slightly lower levels of CSF tau than patients in other studies with similar populations [4,5]. Evaluation of tilavonemab safety and efficacy in these patients remains ongoing.
- | gosuranemab (BIIB092) / Biogen, UCB0107 / UCB, tilavonemab (ABBV-8E12) / AbbVie
Journal: Immunotherapy in progressive supranuclear palsy. (Pubmed Central) - Jun 11, 2020
The likely role of extracellular tau in the progression of PSP makes tau a natural target for targeted immunotherapy. Clinical trials are still in early stages, and although tau immunotherapy has largely been shown to be safe, efficacy has yet to be demonstrated.
- tilavonemab (ABBV-8E12) / AbbVie
Safety and Efficacy of Tilavonemab (ABBV-8E12), a Humanized Anti-Tau Monoclonal Antibody, for the Treatment of Progressive Supranuclear Palsy: Results From a Phase 2, Randomized, Placebo-Controlled, Multicenter Study () - May 20, 2020 - Abstract #AAN2020AAN_5308;
- || tilavonemab (ABBV-8E12) / AbbVie
Trial primary completion date: A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP) (clinicaltrials.gov) - Jan 7, 2020
P2, N=378, Completed, Sponsor: AbbVie
Clinical trials are still in early stages, and although tau immunotherapy has largely been shown to be safe, efficacy has yet to be demonstrated. Trial primary completion date: Jul 2019 --> Nov 2019
- ||| tilavonemab (ABBV-8E12) / AbbVie
Trial completion, Trial completion date, Trial primary completion date: An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP) (clinicaltrials.gov) - Dec 16, 2019
P2, N=143, Completed, Sponsor: AbbVie
Trial primary completion date: Jul 2019 --> Nov 2019 Active, not recruiting --> Completed | Trial completion date: Sep 2022 --> Nov 2019 | Trial primary completion date: Sep 2022 --> Nov 2019
- |||| tilavonemab (ABBV-8E12) / AbbVie
Trial completion, Trial completion date, Trial primary completion date: A Study to Assess Efficacy, Safety, Tolerability, and Pharmacokinetics of ABBV-8E12 in Subjects With Progressive Supranuclear Palsy (PSP) (clinicaltrials.gov) - Dec 11, 2019
P2, N=378, Completed, Sponsor: AbbVie
Active, not recruiting --> Completed | Trial completion date: Sep 2022 --> Nov 2019 | Trial primary completion date: Sep 2022 --> Nov 2019 Active, not recruiting --> Completed | Trial completion date: Mar 2020 --> Nov 2019 | Trial primary completion date: Mar 2020 --> Jul 2019
- || tilavonemab (ABBV-8E12) / AbbVie
Trial completion, Trial completion date, Trial primary completion date: Extension Study of ABBV-8E12 in Patients With Progressive Supranuclear Palsy (PSP) Who Completed Study C2N-8E12-WW-104 (clinicaltrials.gov) - Dec 3, 2019
P1, N=3, Completed, Sponsor: AbbVie
Active, not recruiting --> Completed | Trial completion date: Mar 2020 --> Nov 2019 | Trial primary completion date: Mar 2020 --> Jul 2019 Active, not recruiting --> Completed | Trial completion date: Nov 2020 --> Nov 2019 | Trial primary completion date: Sep 2020 --> Nov 2019
- ABBV-8E12 / AbbVie
Clinical Correlates of Genetic and Biomarker Profiles in Patients with Progressive Supranuclear Palsy: Data from the ARISE Study (Agora 2 West, Level 2) - Sep 24, 2019 - Abstract #MDSCongress2019MDS_387;
P2
Data indicated a positive trend between plasma NfL and disease severity. Lower whole brain, midbrain, and frontal lobe volumes were significantly correlated with both plasma NfL levels and total PSPRS disease severity.
- || ABBV-8E12 / AbbVie
PSP treatment pipeline. Phase 2 PASSPORT study on Anti-tau antibody https://t.co/oIRqCMWuJ4 Phase 2 ARISE study for tau antibody ongoing, preclinical data here. ABBV8E12 https://t.co/oIRqCMWuJ4 UCB (microtubule target) anti tau antibody Phase 1 study https://t.co/o0CZ56EeJH (Twitter) - Sep 22, 2019
- | tilavonemab (ABBV-8E12) / AbbVie
Enrollment closed, Enrollment change: An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP) (clinicaltrials.gov) - Aug 4, 2019
P2, N=142, Active, not recruiting, Sponsor: AbbVie
Lower whole brain, midbrain, and frontal lobe volumes were significantly correlated with both plasma NfL levels and total PSPRS disease severity. Enrolling by invitation --> Active, not recruiting | N=378 --> 142
- || tilavonemab (ABBV-8E12) / AbbVie
Enrollment status: An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP) (clinicaltrials.gov) - May 30, 2019
P2, N=378, Enrolling by invitation, Sponsor: AbbVie
Enrolling by invitation --> Active, not recruiting | N=378 --> 142 Recruiting --> Enrolling by invitation
- ||| tilavonemab (ABBV-8E12) / AbbVie
Enrollment closed, Trial primary completion date: A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - Mar 28, 2019
P2, N=400, Active, not recruiting, Sponsor: AbbVie
Recruiting --> Enrolling by invitation Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2020 --> Apr 2021
- |||| tilavonemab (ABBV-8E12) / AbbVie
Enrollment open, Trial completion date, Trial initiation date, Trial primary completion date: An Extension Study of ABBV-8E12 in Early Alzheimer's Disease (AD) (clinicaltrials.gov) - Mar 26, 2019
P2, N=360, Enrolling by invitation, Sponsor: AbbVie
Recruiting --> Active, not recruiting | Trial primary completion date: Dec 2020 --> Apr 2021 Not yet recruiting --> Enrolling by invitation | Trial completion date: Aug 2027 --> Oct 2026 | Initiation date: Nov 2018 --> Mar 2019 | Trial primary completion date: Aug 2027 --> Oct 2026
- || tilavonemab (ABBV-8E12) / AbbVie
Enrollment status: An Extension Study of ABBV-8E12 in Progressive Supranuclear Palsy (PSP) (clinicaltrials.gov) - Mar 21, 2019
P2, N=378, Recruiting, Sponsor: AbbVie
Not yet recruiting --> Enrolling by invitation | Trial completion date: Aug 2027 --> Oct 2026 | Initiation date: Nov 2018 --> Mar 2019 | Trial primary completion date: Aug 2027 --> Oct 2026 Enrolling by invitation --> Recruiting
- || tilavonemab (ABBV-8E12) / AbbVie
Trial completion date: A Study to Evaluate the Efficacy and Safety of ABBV-8E12 in Participants With Early Alzheimer's Disease (clinicaltrials.gov) - Mar 6, 2019
P2, N=400, Recruiting, Sponsor: AbbVie
Enrolling by invitation --> Recruiting Trial completion date: Oct 2021 --> Jul 2021