Alzamend Neuro Announces Completion of a Novel Head Coil by Tesla for Measuring Brain Structure Lithium Levels in Five Upcoming Phase II Clinical Trials at Massachusetts General Hospital
Alzamend Neuro (NASDAQ: ALZN) announced the completion of a groundbreaking head coil by Tesla Dynamic Coils BV, essential for five upcoming Phase II clinical trials. The trials, conducted at Massachusetts General Hospital, will compare AL001 versus marketed lithium carbonate in healthy individuals and patients with Alzheimer's, bipolar disorder, major depressive disorder, and PTSD.
The specialized head coil enables whole-brain imaging of lithium with high resolution, allowing precise quantification within brain structures. Previous nonclinical studies showed AL001 optimizes brain absorption with lower blood concentration levels compared to lithium carbonate. This innovation could potentially eliminate the need for lithium therapeutic drug monitoring while providing safer dosing options and expanding the therapeutic index.
Alzamend Neuro (NASDAQ: ALZN) ha annunciato il completamento di una innovativa bobina per la testa realizzata da Tesla Dynamic Coils BV, fondamentale per cinque prossimi studi clinici di Fase II. Gli studi, condotti presso il Massachusetts General Hospital, confronteranno AL001 con il litio carbonato commercializzato in individui sani e pazienti con Alzheimer, disturbo bipolare, disturbo depressivo maggiore e PTSD.
La bobina specializzata per la testa consente l'imaging dell'intero cervello del litio con alta risoluzione, permettendo una quantificazione precisa all'interno delle strutture cerebrali. Studi non clinici precedenti hanno dimostrato che AL001 ottimizza l'assorbimento cerebrale con livelli di concentrazione nel sangue inferiori rispetto al litio carbonato. Questa innovazione potrebbe eliminare la necessità di monitoraggio terapeutico del litio, offrendo opzioni di dosaggio più sicure ed espandendo l'indice terapeutico.
Alzamend Neuro (NASDAQ: ALZN) anunció la finalización de una innovadora bobina para la cabeza por Tesla Dynamic Coils BV, esencial para cinco próximos ensayos clínicos de Fase II. Los ensayos, realizados en el Massachusetts General Hospital, compararán AL001 con el carbonato de litio comercializado en individuos sanos y pacientes con Alzheimer, trastorno bipolar, trastorno depresivo mayor y PTSD.
La bobina especializada para la cabeza permite la obtención de imágenes del cerebro completo del litio con alta resolución, permitiendo una cuantificación precisa dentro de las estructuras cerebrales. Estudios no clínicos anteriores mostraron que AL001 optimiza la absorción cerebral con niveles de concentración en sangre más bajos en comparación con el carbonato de litio. Esta innovación podría eliminar la necesidad de monitoreo terapéutico del litio, proporcionando opciones de dosificación más seguras y ampliando el índice terapéutico.
Alzamend Neuro (NASDAQ: ALZN)는 Tesla Dynamic Coils BV가 제작한 획기적인 헤드 코일의 완공을 발표했습니다. 이는 다가오는 다섯 개의 2상 임상 시험에 필수적입니다. 이 시험은 매사추세츠 종합 병원에서 진행되며, AL001과 시판 중인 리튬 탄산염을 건강한 개인 및 알츠하이머, 양극성 장애, 주요 우울 장애, PTSD 환자와 비교합니다.
전문 헤드 코일은 리튬의 고해상도 전뇌 이미징을 가능하게 하여 뇌 구조 내에서 정밀한 정량화를 허용합니다. 이전 비임상 연구에서는 AL001이 리튬 탄산염에 비해 낮은 혈중 농도 수준으로 뇌 흡수를 최적화한다는 것을 보여주었습니다. 이 혁신은 리튬 치료 약물 모니터링의 필요성을 없앨 수 있으며, 더 안전한 투여 옵션을 제공하고 치료 지수를 확장할 수 있습니다.
Alzamend Neuro (NASDAQ: ALZN) a annoncé l'achèvement d'une bobine de tête révolutionnaire par Tesla Dynamic Coils BV, essentielle pour cinq prochains essais cliniques de Phase II. Les essais, réalisés à l'hôpital général du Massachusetts, compareront AL001 au carbonate de lithium commercialisé chez des individus en bonne santé et des patients atteints de la maladie d'Alzheimer, de troubles bipolaires, de troubles dépressifs majeurs et de PTSD.
La bobine de tête spécialisée permet une imagerie cérébrale complète du lithium avec une haute résolution, permettant une quantification précise au sein des structures cérébrales. Des études non cliniques antérieures ont montré qu'AL001 optimise l'absorption cérébrale avec des niveaux de concentration sanguine plus bas par rapport au carbonate de lithium. Cette innovation pourrait potentiellement éliminer la nécessité de surveiller le traitement au lithium tout en offrant des options de dosage plus sûres et en élargissant l'index thérapeutique.
Alzamend Neuro (NASDAQ: ALZN) gab die Fertigstellung einer bahnbrechenden Kopfspule durch Tesla Dynamic Coils BV bekannt, die für fünf bevorstehende klinische Studien der Phase II entscheidend ist. Die Studien, die im Massachusetts General Hospital durchgeführt werden, vergleichen AL001 mit dem vermarkteten Lithiumcarbonat bei gesunden Personen und Patienten mit Alzheimer, bipolaren Störungen, schweren depressiven Störungen und PTSD.
Die spezialisierte Kopfspule ermöglicht die hochauflösende Ganzhirnbildgebung von Lithium, wodurch eine präzise Quantifizierung innerhalb der Gehirnstrukturen ermöglicht wird. Frühere nichtklinische Studien zeigten, dass AL001 die Gehirnaufnahme mit niedrigeren Blutkonzentrationswerten im Vergleich zu Lithiumcarbonat optimiert. Diese Innovation könnte die Notwendigkeit der therapeutischen Überwachung von Lithium beseitigen und sicherere Dosierungsoptionen bieten sowie den therapeutischen Index erweitern.
- Development of innovative head coil enabling precise lithium brain level measurements
- Advancement to Phase II clinical trials across multiple indications
- Nonclinical studies showed AL001's superior brain absorption with lower blood concentration
- Potential elimination of therapeutic drug monitoring requirement
- Extended development time for head coil completion
- Multiple clinical trials still pending initiation
Insights
The completion of Tesla's specialized lithium head coil represents a significant technological breakthrough that could fundamentally transform Alzamend's clinical development program. This proprietary imaging technology provides unprecedented capabilities to visualize and quantify lithium distribution in specific brain structures, offering a important competitive advantage in the development of AL001.
The planned five Phase II clinical trials at Massachusetts General Hospital mark an ambitious and comprehensive clinical program targeting multiple high-value indications: Alzheimer's disease, bipolar disorder, major depressive disorder, and PTSD. This multi-indication strategy significantly expands the potential market opportunity and could accelerate the path to commercialization across several conditions simultaneously.
The preclinical data showing AL001's optimized brain absorption with lower blood concentrations is particularly noteworthy. If validated in human trials, this could lead to three critical advantages:
- Improved safety profile through reduced systemic exposure
- Elimination of therapeutic drug monitoring requirements
- Enhanced therapeutic index allowing for more optimal dosing
The collaboration with Massachusetts General Hospital, a premier research institution, adds significant credibility to the program and suggests robust trial design and execution. The ability to precisely measure lithium levels in brain structures could potentially reduce clinical trial risks by providing clear pharmacokinetic endpoints and enabling more informed dose selection.
This technological advancement positions Alzamend at the forefront of lithium-based therapeutic development, with potential applications extending beyond their current pipeline. The ability to visualize lithium distribution in the brain could become an invaluable tool for drug development and patient monitoring, potentially creating additional revenue streams through technology licensing or partnerships.
- Head-to-head studies of AL001 versus a marketed lithium carbonate product will be conducted for comparisons of lithium blood and brain/brain-structure pharmacokinetics in healthy, Alzheimer’s disease, BD, MDD, and PTSD subjects
Tesla Head Coil (Tesla Dynamic Coils BV) Photo Courtesy of Alzamend Neuro, Inc. All rights reserved and proprietary, @2025 #Alzamend @Alzamend $Alzamend @LiProSal #LiProSal $LiProSal #MassachusettsGeneralHospital $MassachusettsGeneralHospital #Whole-brain_imaging $whole-brain_imaging #one-of-a-kind_head_coil
In collaboration with Massachusetts General Hospital as its contract research organization, Alzamend intends to undertake pioneering clinical trials, with a goal to assess how lithium levels in the brain differ when using AL001 compared to marketed lithium salts, both in healthy individuals and patients with Alzheimer’s, BD, MDD and PTSD. The one-of-a-kind engineered head coil will enable whole-brain imaging of lithium with remarkable resolution, allowing precise quantification within brain structures. The coil will be used to help identify the disease-specific target doses of AL001 that improve the balance of safety and efficacy compared to lithium carbonate. The coil will also be used to scan the entire brain, helping us clearly identify the different structures and important areas necessary for understanding how lithium works and moves within the brain.
These studies are expected to provide greater clarity on how lithium treatments reach the brain, showcasing AL001’s superior ability to target brain structures while reducing systemic exposures. Nonclinical (mouse) studies have already demonstrated that AL001 optimizes brain absorption with lower blood concentration levels when compared to lithium carbonate, suggesting promising human applications. This cutting-edge approach ensures that lithium via AL001 remains effective in the brain with significantly reduced risks of harmful side effects on the kidneys and thyroid. By enabling safer dosing, expanding the therapeutic index and potentially removing the need for lithium therapeutic drug monitoring (“TDM”), AL001 represents a potential groundbreaking advance. These innovations could deliver more effective and secure treatments to vulnerable groups, such as Alzheimer’s patients, highlighting AL001’s potential in improving patient care and treatment efficacy.
“We want to thank Tesla for working with us to create this one-of-a-kind lithium head coil,” stated Stephan Jackman, Chief Executive Officer of Alzamend. “The development of the coil was a long time coming, but we believe the time and effort was necessary to allow us unprecedented knowledge as to how lithium interacts within our brains. We believe that our upcoming studies, utilizing the head coil, has the potential to broaden the application of lithium treatment across numerous neurodegenerative diseases and psychiatric disorders. Its completion allows us to solidify our timeline for the forthcoming clinical trials in collaboration with Massachusetts General Hospital. We look forward to sharing additional details regarding these trials soon.”
About AL001
AL001 is a novel lithium-delivery system that has the potential to provide the benefits of marketed lithium salts while mitigating or avoiding currently experienced toxicities associated with lithium. Results from Alzamend’s completed Phase IIA multiple-ascending dose study of AL001 in Alzheimer’s patients and healthy subjects identified a maximum tolerated dose (“MTD”), as assessed by an independent safety review committee. This MTD is designed to be unlikely to require TDM while providing lithium at a relatively modest but effective dose. AL001 is designed to favorably distribute lithium in the brain resulting in lower exposure of other body organs and an improved safety profile compared to currently marketed lithium salts. This can serve to mitigate or obviate the disadvantageously low ceiling for toxicity of marketed lithium salts that has limited their usefulness to patients and prescribers.
About Alzamend Neuro
Alzamend Neuro is a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s, BD, MDD and PTSD. Our mission is to rapidly develop and market safe and effective treatments. Our current pipeline consists of two novel therapeutic drug candidates, AL001 - a patented ionic cocrystal technology delivering lithium via a therapeutic combination of lithium, salicylate and L-proline, and ALZN002 - a patented method using a mutant-peptide sensitized cell as a cell-based therapeutic vaccine that seeks to restore the ability of a patient’s immunological system to combat Alzheimer’s by removing beta-amyloid from the brain. The latter is a second-generation active-immunity approach designed to mitigate the disadvantages of approved passive immunity marketed antibody products, particularly by reducing the required frequency and costs of dosing associated with antibody products. Both of our product candidates are licensed from the University of South Florida Research Foundation, Inc. pursuant to royalty-bearing exclusive worldwide licenses.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “believes,” “plans,” “anticipates,” “projects,” “estimates,” “expects,” “intends,” “strategy,” “future,” “opportunity,” “may,” “will,” “should,” “could,” “potential,” or similar expressions. Statements that are not historical facts are forward-looking statements. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties. Forward-looking statements speak only as of the date they are made, and Alzamend undertakes no obligation to update any of them publicly in light of new information or future events. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors. More information, including potential risk factors, that could affect Alzamend’s business and financial results are included in Alzamend’s filings with the
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Email: Info@Alzamend.com or call: 1-844-722-6333
Source: Alzamend Neuro, Inc.
FAQ
What is the purpose of Tesla's new head coil for ALZN's clinical trials?
How many Phase II clinical trials is ALZN planning with the new head coil?
What advantages does AL001 show over traditional lithium carbonate in preliminary studies?
How might ALZN's AL001 improve current lithium-based treatments?
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