levetiracetam low dose (AGB101) / AgeneBio 
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  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Review, Journal:  The Bidirectional Relationship Between Epilepsy and Alzheimer's Disease. (Pubmed Central) -  Feb 8, 2025   
    Anti-seizure medications (ASMs), particularly low-dose levetiracetam, show potential not only for seizure control but also for mitigating amyloid deposition, tau hyperphosphorylation, and cognitive decline...The bidirectional nature of AD and epilepsy emphasizes the need for integrated diagnostics, including EEG and biomarker assessments, to guide early intervention and targeted therapies. Future research should focus on the mechanistic interplay between amyloid, tau, and hyperexcitability, alongside trials of ASM regimens, to refine therapeutic strategies and improve outcomes in this population.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Biomarker, Clinical, Journal:  Biomarkers. (Pubmed Central) -  Jan 12, 2025   
    That reduction in atrophy was significantly coupled with the change in CDR-SB and with plasma biomarkers of disease. These exploratory analyses would be consistent with a reduction in neurodegeneration in the non-carriers of ApoE4 treated with AGB101 prior to a clinical diagnosis of dementia.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Biomarker, Clinical, Journal:  Alzheimer's Imaging Consortium. (Pubmed Central) -  Jan 12, 2025   
    That reduction in atrophy was significantly coupled with the change in CDR-SB and with plasma biomarkers of disease. These exploratory analyses would be consistent with a reduction in neurodegeneration in the non-carriers of ApoE4 treated with AGB101 prior to a clinical diagnosis of dementia.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Phase classification, Enrollment change:  Clinical Trial of AGB101 for Mild Cognitive Impairment (clinicaltrials.gov) -  Jun 20, 2024   
    P2,  N=60, Not yet recruiting, 
    These exploratory analyses would be consistent with a reduction in neurodegeneration in the non-carriers of ApoE4 treated with AGB101 prior to a clinical diagnosis of dementia. Phase classification: P3 --> P2 | N=1040 --> 60
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    The HOPE4MCI study: AGB101 treatment reduces entorhinal cortex atrophy in patients with amnestic mild cognitive impairment due to Alzheimer (Exhibit (Pennsylvania Convention Center); In-Person) -  Jun 19, 2024 - Abstract #AAIC2024AAIC_4101;    
    (2024), progression on the primary clinical/cognitive endpoint of the Clincial Dementia Rating Scale Sum of Boxes score (CDR-SB) occurred over the 78-week protocol in the HOPE4MCI study and non-carriers of ApoE4 treated with AGB101 showed a substantially more favorable effect than carriers. Here we report that treatment with AGB101, in those participants significantly reduced atrophy of the entorhinal cortex.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Enrollment closed, Trial completion date, Trial primary completion date:  Low vs. Standard Daily Doses of Antiepileptic Drugs in Newly Diagnosed, Previously Untreated Epilepsy(STANDLOW) (clinicaltrials.gov) -  Mar 12, 2024   
    P4,  N=374, Active, not recruiting, 
    Here we report that treatment with AGB101, in those participants significantly reduced atrophy of the entorhinal cortex. Unknown status --> Active, not recruiting | Trial completion date: Dec 2021 --> Aug 2024 | Trial primary completion date: Jul 2021 --> Jun 2024
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Trial completion date, Trial primary completion date:  Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Schizophrenia (clinicaltrials.gov) -  Feb 15, 2024   
    P=N/A,  N=30, Recruiting, 
    Unknown status --> Active, not recruiting | Trial completion date: Dec 2021 --> Aug 2024 | Trial primary completion date: Jul 2021 --> Jun 2024 Trial completion date: Dec 2023 --> Jun 2024 | Trial primary completion date: Dec 2023 --> Jun 2024
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Journal:  The HOPE4MCI study: A randomized double-blind assessment of AGB101 for the treatment of MCI due to AD. (Pubmed Central) -  Feb 15, 2024   
    The possibility that ApoE-4 carriers and noncarriers will respond differently to therapeutic intervention is consistent with recently reported findings from biologics and the present results show further testing of AGB101 in patients with MCI due to AD who are noncarriers of the ApoeE-4 allele is warranted. Conclusions from the HOPE4MCI study are limited primarily due to the small sample size and results can only be regarded as a guide to future research.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    STANDARD VERSUS LOW-DOSE LEVETIRACETAM FOR SEIZURE PROPHYLAXIS IN ELDERLY TRAUMATIC BRAIN INJURIES () -  Jan 25, 2023 - Abstract #SCCM2023SCCM_1824;    
    Levetiracetam utilized at a dose of 250 mg twice daily may be an option for seizure prophylaxis in elderly TBI patients and may be considered as a strategy to mitigate levetiracetam-related behavioral events. Further randomized controlled trials with larger sample sizes are needed to confirm efficacy of low-dose levetiracetam and better quantify behavioral event rates associated with different regimens.
  • ||||||||||  TBA (ONSITE - HALL G3) -  Dec 23, 2022 - Abstract #ADPD2023ADPD_964;    
    P2/3
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Low dose of levetiracetam counteracts Aβ-induced alterations of hippocampal network states by restoring fast-spiking interneuron activity (SDCC Halls B-H) -  Oct 10, 2022 - Abstract #Neuroscience2022NEUROSCIENCE_6942;    
    Further randomized controlled trials with larger sample sizes are needed to confirm efficacy of low-dose levetiracetam and better quantify behavioral event rates associated with different regimens. The precise modulation of neuronal circuits with Levetiracetam is a promising strategy to counteract early-stage alterations in hippocampal activity by modulating FSN in different memory-relevant neuronal network states.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    LILYPADD TRIAL: TARGETING HIPPOCAMPAL HYPERCONNECTIVITY IN COGNITIVELY NORMAL OLDER ADULTS AT RISK FOR ALZHEIMER’S DISEASE WITH AGB101. () -  Oct 5, 2022 - Abstract #CTAD2022CTAD_36;    
    P2
    These proof-of-concept results warrant All abstracts are embargoed until the day and time of presentation at the CTAD Conference S88 further assessment of AGB101 in cognitively normal older adults in the earliest phases of the AD continuum before symptomatic cognitive impairment and a diagnosis of aMCI. A more extended treatment protocol could be used to determine whether progression of impairment can be attenuated by such intervention.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Trial completion date, Trial primary completion date:  Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Schizophrenia (clinicaltrials.gov) -  Apr 1, 2022   
    P=N/A,  N=30, Recruiting, 
    Future studies should explore additional neuroimaging methods and alternate study designs to assess the effect of LEV on hippocampal activity in schizophrenia. Trial completion date: Dec 2022 --> Dec 2023 | Trial primary completion date: Dec 2022 --> Dec 2023
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    LOW-DOSE LEVETIRACETAM VERSUS PHENYTOIN FOR EARLY SEIZURE PROPHYLAXIS AFTER TRAUMATIC BRAIN INJURY ([VIRTUAL]) -  Mar 23, 2022 - Abstract #SCCM2022SCCM_1741;    
    Differences in ICU and hospital LOS were more likely attributable to the LEV cohort’s severity of injury, as measured by lower median GCS scores within the first 24 hours of admission in addition to an increased need for hyperosmolar and neurosurgical intervention. Larger, prospective studies involving more patients with penetrating TBIs would be necessary in order to validate observations made in this study.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Trial completion:  Network-Level Mechanisms for Preclinical Alzheimer's Disease Development (clinicaltrials.gov) -  Dec 10, 2021   
    P2,  N=26, Completed, 
    Longitudinal studies are needed to further investigate medication use in patients with SWS. Active, not recruiting --> Completed
  • ||||||||||  levetiracetam / Generic mfg.
    Evaluation of levetiracetam dosing for seizure prophylaxis in traumatic brain injury () -  Sep 10, 2021 - Abstract #NCS2021NCS_403;    
    Although levetiracetam is frequently used for this indication, it is not currently recommended in the Brain Trauma Foundation guidelines over phenytoin due to insufficient evidence...Our study evaluated the incidence of seizure within seven days of TBI when utilizing low-dose levetiracetam (500 mg twice daily), compared to high-dose levetiracetam (greater than 500 mg twice daily)...Conclusions There were no statistically significant differences in seizure rates when comparing low-dose to high-dose levetiracetam. Levetiracetam 500 mg twice daily may be as effective as levetiracetam doses greater than 500 mg twice daily for early onset post-traumatic seizure prophylaxis.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Trial completion date, Trial primary completion date:  Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Schizophrenia (clinicaltrials.gov) -  Sep 2, 2021   
    P=N/A,  N=30, Recruiting, 
    Levetiracetam 500 mg twice daily may be as effective as levetiracetam doses greater than 500 mg twice daily for early onset post-traumatic seizure prophylaxis. Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Low-dose Levetiracetam for Treatment of Age-related Cognitive Impairment and to Delay Progression of Alzheimer’s Dementia () -  Aug 7, 2021 - Abstract #CTAD2021CTAD_53;    
    P2/3
    AgeneBio developed a unique approach to Intellectual Property protection related to the need for a low, consistent concentration of drug to be efficacious. Thus, AgeneBio has strong protection for AGB101 with multiple patents including the se of low-dose levetiracetam to treat age-related cognitive impairment and to delay progression of Alzheimer’s dementia, the low-dose, extended-release formulation, and the relevant pharmacokinetic exposure range.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    [VIRTUAL] AgeneBio () -  May 31, 2021 - Abstract #BIO2021BIO_229;    
    AgeneBio's Phase 2b candidate AGB101 is the first and only therapeutic being investigated to target hippocampal overactivity to slow progression to and delay the onset of Alzheimer's dementia...AgeneBio also has a novel GABA-A alpha5 small molecule program in late discovery stage being investigated multiple neurological and psychiatric indications. AgeneBio is presenting as part of the NIH Innovation Zone.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Enrollment closed, Enrollment change:  Network-Level Mechanisms for Preclinical Alzheimer's Disease Development (clinicaltrials.gov) -  May 14, 2021   
    P2,  N=26, Active, not recruiting, 
    AgeneBio is presenting as part of the NIH Innovation Zone. Recruiting --> Active, not recruiting | N=50 --> 26
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Enrollment closed, Trial primary completion date:  Hope4MCI: Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease (clinicaltrials.gov) -  May 4, 2021   
    P2/3,  N=164, Active, not recruiting, 
    Recruiting --> Active, not recruiting | N=50 --> 26 Recruiting --> Active, not recruiting | Trial primary completion date: Jul 2022 --> Oct 2022
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    [VIRTUAL] Low-dose levetiracetam versus phenytoin for early seizure prophylaxis after traumatic brain injury () -  Dec 26, 2020 - Abstract #ASHP2020ASHP_4903;    
    Demographic data to be collected include: age, sex, weight, Glasgow-Coma Score (GCS) on admission, best and worst GCS within 24 hours of TBI, if penetrating versus blunt TBI, and interventions performed on patients (e.g. intracranial pressure monitoring or neurosurgical intervention). Categorical data will be analyzed via Fisher’s exact test and continuous data will be analyzed via student’s t-test or Mann-Whitney U test.
  • ||||||||||  Briviact (brivaracetam) / UCB
    [VIRTUAL] Brivaracetam: Long term experience in Mexico () -  Nov 28, 2020 - Abstract #AES2020AES_905;    
    B: Patients on levetiracetam (LVT) treatment and switched to brivaracetam due to undesirable adverse events...The most common and useful combination was with lacosamide...The primary adverse effect was a long-lasting drowsy-lethargic state, which impeded patients' daily activities. Funding: No funding was required for this study
  • ||||||||||  Fycompa (perampanel) / Eisai, levetiracetam low dose (AGB101) / AgeneBio
    Clinical, Journal:  Experience of Low Dose Perampanel to Add-on in Glioma Patients with Levetiracetam-uncontrollable Epilepsy. (Pubmed Central) -  Nov 21, 2020   
    Our study revealed anti-epileptic efficacy of low dose PER 2-4 mg as first add-on therapy to LEV in glioma patients who have failed or intolerable to LEV monotherapy. Low dose PER added on to LEV may have favorable efficacy with tolerable adverse effects in glioma patients with LEV-uncontrollable epilepsy.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Trial completion date, Trial primary completion date:  Effects of Low-dose Levetiracetam on Clinical Symptoms, Cognition and Hippocampal Hyperactivity in Schizophrenia (clinicaltrials.gov) -  Oct 22, 2020   
    P=N/A,  N=30, Recruiting, 
    Low dose PER added on to LEV may have favorable efficacy with tolerable adverse effects in glioma patients with LEV-uncontrollable epilepsy. Trial completion date: Dec 2020 --> Dec 2021 | Trial primary completion date: Dec 2020 --> Dec 2021
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Enrollment open:  Network-Level Mechanisms for Preclinical Alzheimer's Disease Development (clinicaltrials.gov) -  Oct 1, 2020   
    P2,  N=50, Recruiting, 
    However, drug screening through this model may yield superior drugs with novel antiseizure mechanisms. Suspended --> Recruiting
  • ||||||||||  Journal:  Treatment of Refractory Convulsive Status Epilepticus: A Comprehensive Review by the American Epilepsy Society Treatments Committee. (Pubmed Central) -  Aug 22, 2020   
    A structured literature search (MEDLINE, Embase, CENTRAL, CINAHL) was performed to identify original studies on the treatment of CRSE in children and adults using IV brivaracetam, ketamine, lacosamide, levetiracetam (LEV), midazolam (MDZ), pentobarbital (PTB; and thiopental), propofol (PRO), and valproic acid (VPA)...For the treatment of established convulsive SE (ie, not RSE), LEV, VPA, and fosphenytoin are likely equally effective, but whether this is also true for CRSE is unknown. Triple-masked, randomized controlled trials are needed to compare the effectiveness of parenteral anesthetizing and nonanesthetizing ASMs in the treatment of CRSE.
  • ||||||||||  levetiracetam low dose (AGB101) / AgeneBio
    Trial completion date:  Hope4MCI: Study of AGB101 in Mild Cognitive Impairment Due to Alzheimer's Disease (clinicaltrials.gov) -  Aug 14, 2020   
    P2/3,  N=160, Recruiting, 
    Triple-masked, randomized controlled trials are needed to compare the effectiveness of parenteral anesthetizing and nonanesthetizing ASMs in the treatment of CRSE. Trial completion date: Mar 2023 --> Dec 2022
  • ||||||||||  levetiracetam / Generic mfg., levetiracetam low dose (AGB101) / AgeneBio
    Clinical, Clinical data, PK/PD data, Journal:  Pharmacokinetic and Pharmacodynamic modeling of levetiracetam: investigation of factors affecting the clinical outcome. (Pubmed Central) -  Aug 5, 2020   
    Using discrete time Markov chains, it was shown that the transition probability from focal seizures to focal to bilateral tonic-clonic is significantly altered in relation to patient's CrCL.Simulations showed that dose should be adjusted in relation to CrCL, while low doses of levetiracetam are more efficient for seizure control. Modeling and simulation in every-day clinical practice, may provide significant information for the optimization of seizure control using well-known agents.