Alzamend Neuro Announces Initiation Date of Phase II Clinical Trial of AL001 for Treatment of Alzheimer’s Disease to take Place at Massachusetts General Hospital
Alzamend Neuro (NASDAQ: ALZN) has announced plans to initiate a Phase II clinical trial of AL001 for Alzheimer's disease treatment in Q4 2025 at Massachusetts General Hospital. The study follows the successful completion of a head coil by Tesla Dynamic Coils BV.
The trial will compare AL001 with marketed lithium carbonate, focusing on lithium blood and brain pharmacokinetics in Alzheimer's patients. Previous mouse studies showed AL001 achieves better brain absorption while maintaining lower blood lithium levels, potentially eliminating the need for therapeutic drug monitoring (TDM).
The company previously completed a Phase IIA multiple-ascending dose study, establishing a maximum tolerated dose that likely won't require TDM while providing effective lithium dosing. AL001 is designed to improve lithium distribution in the brain while reducing exposure to other organs, potentially offering a safer profile compared to current lithium salts.
Alzamend Neuro (NASDAQ: ALZN) ha annunciato piani per avviare uno studio clinico di Fase II di AL001 per il trattamento dell'Alzheimer nel quarto trimestre del 2025 presso il Massachusetts General Hospital. Lo studio segue il completamento con successo di una bobina cranica da parte di Tesla Dynamic Coils BV.
Il trial confronterà AL001 con il carbonato di litio commercializzato, concentrandosi sulla farmacocinetica del litio nel sangue e nel cervello nei pazienti affetti da Alzheimer. Studi precedenti su topi hanno dimostrato che AL001 raggiunge una migliore assorbimento cerebrale mantenendo livelli di litio nel sangue più bassi, eliminando potenzialmente la necessità di monitoraggio terapeutico dei farmaci (TDM).
L'azienda ha precedentemente completato uno studio di Fase IIA a dosi multiple ascendenti, stabilendo una dose massima tollerata che probabilmente non richiederà TDM, garantendo al contempo un dosaggio efficace di litio. AL001 è progettato per migliorare la distribuzione del litio nel cervello riducendo l'esposizione ad altri organi, offrendo potenzialmente un profilo più sicuro rispetto ai sali di litio attuali.
Alzamend Neuro (NASDAQ: ALZN) ha anunciado planes para iniciar un ensayo clínico de Fase II de AL001 para el tratamiento de la enfermedad de Alzheimer en el cuarto trimestre de 2025 en el Massachusetts General Hospital. El estudio sigue la exitosa finalización de una bobina craneal por parte de Tesla Dynamic Coils BV.
El ensayo comparará AL001 con carbonato de litio comercializado, centrándose en la farmacocinética del litio en sangre y cerebro en pacientes con Alzheimer. Estudios previos en ratones mostraron que AL001 logra una mejor absorción cerebral mientras mantiene niveles de litio en sangre más bajos, lo que podría eliminar la necesidad de monitoreo terapéutico de medicamentos (TDM).
La empresa completó previamente un estudio de Fase IIA de dosis múltiples ascendentes, estableciendo una dosis máxima tolerada que probablemente no requerirá TDM mientras proporciona una dosificación efectiva de litio. AL001 está diseñado para mejorar la distribución de litio en el cerebro mientras reduce la exposición a otros órganos, ofreciendo potencialmente un perfil más seguro en comparación con las sales de litio actuales.
Alzamend Neuro (NASDAQ: ALZN)는 2025년 4분기에 매사추세츠 종합병원에서 알츠하이머병 치료를 위한 AL001의 2상 임상 시험을 시작할 계획을 발표했습니다. 이 연구는 Tesla Dynamic Coils BV의 헤드 코일 성공적인 완공을 따릅니다.
이번 시험은 AL001과 시판 중인 탄산리튬을 비교하며, 알츠하이머 환자에서 리튬의 혈액 및 뇌 약리학적 작용에 중점을 둡니다. 이전 생쥐 연구에서는 AL001이 더 낮은 혈중 리튬 수치를 유지하면서 더 나은 뇌 흡수를 달성한다는 결과가 나왔으며, 이는 치료 약물 모니터링(TDM)의 필요성을 없앨 수 있습니다.
회사는 이전에 여러 용량 상승 연구의 1상 A단계를 완료하였으며, TDM을 필요로 하지 않으면서도 효과적인 리튬 용량을 제공할 수 있는 최대 허용 용량을 설정하였습니다. AL001은 뇌에서 리튬 분포를 개선하고 다른 장기에 대한 노출을 줄이도록 설계되어 현재의 리튬 염에 비해 더 안전한 프로필을 제공할 수 있습니다.
Alzamend Neuro (NASDAQ: ALZN) a annoncé des projets pour initier un essai clinique de phase II d'AL001 pour le traitement de la maladie d'Alzheimer au quatrième trimestre de 2025 au Massachusetts General Hospital. L'étude fait suite à l'achèvement réussi d'une bobine crânienne par Tesla Dynamic Coils BV.
L'essai comparera AL001 avec le carbonate de lithium commercialisé, en se concentrant sur la pharmacocinétique du lithium dans le sang et le cerveau chez les patients atteints d'Alzheimer. Des études antérieures sur des souris ont montré qu'AL001 atteint une meilleure absorption cérébrale tout en maintenant des niveaux de lithium sanguin plus bas, ce qui pourrait éliminer la nécessité d'une surveillance thérapeutique des médicaments (TDM).
L'entreprise a précédemment complété une étude de phase IIA à doses multiples ascendantes, établissant une dose maximale tolérée qui ne nécessitera probablement pas de TDM tout en fournissant un dosage efficace de lithium. AL001 est conçu pour améliorer la distribution du lithium dans le cerveau tout en réduisant l'exposition à d'autres organes, offrant potentiellement un profil plus sûr par rapport aux sels de lithium actuels.
Alzamend Neuro (NASDAQ: ALZN) hat Pläne angekündigt, im vierten Quartal 2025 eine Phase-II-Studie zu AL001 zur Behandlung von Alzheimer im Massachusetts General Hospital zu beginnen. Die Studie folgt auf den erfolgreichen Abschluss einer Kopfspule durch Tesla Dynamic Coils BV.
Die Studie wird AL001 mit dem vermarkteten Lithiumcarbonat vergleichen und sich auf die Pharmakokinetik von Lithium im Blut und im Gehirn bei Alzheimer-Patienten konzentrieren. Frühere Studien an Mäusen zeigten, dass AL001 eine bessere Gehirnaufnahme erreicht, während es niedrigere Lithiumspiegel im Blut aufrechterhält, was möglicherweise die Notwendigkeit der therapeutischen Medikamentenüberwachung (TDM) beseitigt.
Das Unternehmen hat zuvor eine Phase-IIA-Studie mit mehreren aufsteigenden Dosen abgeschlossen, in der eine maximal tolerierte Dosis festgelegt wurde, die voraussichtlich keine TDM erfordert und gleichzeitig eine effektive Lithiumdosierung bietet. AL001 wurde entwickelt, um die Verteilung von Lithium im Gehirn zu verbessern und die Exposition gegenüber anderen Organen zu reduzieren, was potenziell ein sichereres Profil im Vergleich zu aktuellen Lithiumsalzen bietet.
- Successful completion of Phase IIA study with established maximum tolerated dose
- AL001 demonstrates superior brain absorption with lower blood lithium levels in preclinical studies
- Potential elimination of therapeutic drug monitoring requirement
- Partnership with prestigious Massachusetts General Hospital for Phase II trial
- Phase II trial initiation delayed until Q4 2025
- No efficacy data presented from previous Phase IIA study
- Still in early clinical development stages with uncertain outcome
Insights
Alzamend's Phase II clinical trial announcement for AL001 represents a significant advancement in their Alzheimer's disease pipeline. The trial's initiation in Q4 2025 at Massachusetts General Hospital marks the progression from their previously completed Phase IIA multiple-ascending dose study where they established a maximum tolerated dose (MTD).
The technology behind AL001 addresses a critical limitation in lithium-based therapies—the narrow therapeutic window requiring constant monitoring. Current FDA-approved lithium salts (carbonate and citrate) necessitate therapeutic drug monitoring (TDM) to prevent adverse events, creating a substantial treatment burden. AL001's potential elimination of TDM requirements would represent a meaningful clinical advantage if proven in human trials.
Particularly noteworthy is the preclinical evidence showing AL001 improves brain absorption while maintaining lower systemic lithium levels. This pharmacokinetic profile suggests a potentially superior safety margin compared to conventional lithium formulations, addressing the kidney and thyroid side effects that have lithium's broader application.
The successful completion of the specialized head coil by Tesla Dynamic Coils BV indicates tangible progress in trial preparation. This head-to-head comparison against marketed lithium carbonate could provide compelling differentiation data if AL001 demonstrates targeted brain delivery with reduced systemic exposure.
For a
This Phase II trial announcement for AL001 addresses a significant unmet need in Alzheimer's treatment through a novel lithium delivery approach. Lithium has shown neuroprotective properties through multiple mechanisms including glycogen synthase kinase 3β inhibition and autophagy modulation, but its therapeutic application has been severely constrained by its narrow therapeutic index.
What distinguishes AL001 is its reported ability to create favorable brain-to-plasma ratios of lithium. This pharmacokinetic advantage could prove transformative if validated in Phase II, as it potentially overcomes the fundamental safety limitations that have hindered lithium's broader clinical application in neurodegenerative conditions.
The elimination of therapeutic drug monitoring represents both clinical and economic advantages. From a patient perspective, removal of blood monitoring reduces treatment burden and improves adherence. From a healthcare economics standpoint, it eliminates costs associated with regular laboratory testing and clinical visits for monitoring.
The trial design focusing on comparative pharmacokinetics between AL001 and conventional lithium carbonate should provide definitive evidence of differential brain penetration. The selection of Massachusetts General Hospital as the research partner brings strong neuroimaging capabilities essential for tracking CNS lithium distribution.
If AL001 delivers its promised pharmacokinetic profile in Alzheimer's patients, it could substantially expand lithium's therapeutic utility beyond mood disorders into neurodegeneration—representing a potential paradigm shift in treatment approach rather than merely an incremental formulation improvement.
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 Alzheimer’s subjects
ATLANTA, March 25, 2025 (GLOBE NEWSWIRE) -- Alzamend Neuro, Inc. (Nasdaq: ALZN) (“Alzamend”), a clinical-stage biopharmaceutical company focused on developing novel products for the treatment of Alzheimer’s disease (“Alzheimer’s”), bipolar disorder (“BD”), major depressive disorder (“MDD”) and post-traumatic stress disorder (“PTSD”), today announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment of patients with Alzheimer’s in the fourth quarter of 2025. This study follows the successful completion of a head coil by Tesla Dynamic Coils BV, a key component of the clinical trial.
In collaboration with Massachusetts General Hospital as its contract research organization, Alzamend aims to explore the unique properties of AL001 and its effects on lithium delivery in the brain compared to marketed lithium salts. The study could illuminate the path forward in patients with Alzheimer’s by demonstrating AL001’s targeted effectiveness and reduced systemic side effects. Previous studies in mice have shown that AL001 ensures better brain absorption while maintaining lower levels of lithium in the blood, paving the way for safer and more efficient treatments.
By offering a treatment that potentially eliminates the need for lithium therapeutic drug monitoring (“TDM”), AL001 could revolutionize care for vulnerable patient populations and improve treatment outcomes. Lithium, renowned for its efficacy as a first-line therapy for manic episodes and maintenance in BD, has long been underutilized due to the complexities of TDM. Current lithium salts (carbonate and citrate) approved by the U.S. Food and Drug Administration are limited by a narrow therapeutic window that requires regular TDM of plasma lithium levels and blood chemistry by a clinician to mitigate adverse events.
Alzamend previously completed a Phase IIA multiple-ascending dose study of AL001 in Alzheimer’s patients and healthy subjects, which 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. Moreover, this could signify a major shift in managing conditions like Alzheimer’s, by minimizing risks associated with kidney and thyroid side effects traditionally linked to lithium therapies.
“With AL001, we can potentially introduce a next-generation lithium treatment that offers enhanced safety, better brain targeting, and no need for TDM, promising a leap forward from the current, burdensome options,” stated Stephan Jackman, Chief Executive Officer of Alzamend. “This advancement stands to potentially enhance the lives of over 6.5 million Americans suffering from Alzheimer’s by providing a more effective and user-friendly therapeutic option, potentially reshaping current treatment paradigms and improving patient quality of life substantially.”
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 U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com.
Contacts:
Email: Info@Alzamend.com or call: 1-844-722-6333
FAQ
When will Alzamend Neuro (ALZN) begin its Phase II trial for AL001 in Alzheimer's treatment?
What are the key advantages of ALZN's AL001 compared to traditional lithium treatments?
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How many potential patients could benefit from ALZN's AL001 Alzheimer's treatment?
