A Randomized, Balanced, Phase 1, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Healthy Adult Subjects

The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium Carbonate in healthy volunteers. The main questions this study aims to answer are:
How safe and effective is AL001 when compared to Lithium Carbonate? How is AL001 broken down in the brain and body compared to Lithium Carbonate?
Participants will be asked to:
* Take both the study drug (AL001) and Lithium Carbonate each for a period of 14 days
* Stay overnight at MGH's research unit for two separate 2-week periods
* Participate in two separate 24 hour periods of multiple MRIs and blood draws

Start Date01 May 2025

Sponsor / Collaborator

Alzamend Neuro, Inc.

[+1]

CTR20250683

/ RecruitingNot Applicable

碳酸锂片人体生物等效性研究

[Translation] Study on the bioequivalence of lithium carbonate tablets in human body

主要目的：比较空腹和餐后给药条件下湖南省湘中制药有限公司提供的碳酸锂片（规格：0.25 g）与LABORATOIRES DELBERT持证的碳酸锂片（商品名：TERALITHE®；规格：0.25 g）在中国健康人群吸收程度和吸收速度的差异。次要目的：评价空腹及餐后条件下，湖南省湘中制药有限公司提供的碳酸锂片（规格：0.25 g）与LABORATOIRES DELBERT持证的碳酸锂片（商品名：TERALITHE®；规格：0.25 g）在中国健康人群体内的安全性。

[Translation]

Primary objective: To compare the differences in the extent and rate of absorption of lithium carbonate tablets (specification: 0.25 g) provided by Hunan Xiangzhong Pharmaceutical Co., Ltd. and lithium carbonate tablets (trade name: TERALITHE®; specification: 0.25 g) approved by LABORATOIRES DELBERT in healthy Chinese population under fasting and fed conditions. Secondary objective: To evaluate the safety of lithium carbonate tablets (specification: 0.25 g) provided by Hunan Xiangzhong Pharmaceutical Co., Ltd. and lithium carbonate tablets (trade name: TERALITHE®; specification: 0.25 g) approved by LABORATOIRES DELBERT in healthy Chinese population under fasting and fed conditions.

Start Date29 Mar 2025

Sponsor / Collaborator

Hunan Xiangzhong Pharmaceutical Co., Ltd.

NCT06776848

/ Not yet recruitingPhase 1/2IIT

A Placebo-controlled Evaluation of Low Dose Lithium Carbonate in Patients with TBR1-related Neurocognitive Disorders: a 24-month Multi-centre Pilot Study

TBR1 is a human gene encoding a brain-specific transcription factor, principally expressed in the excitatory neurons of the neocortex. It regulates development of axonal projection and expression of numerous genes involved in autism spectrum disorders (ASD) and intellectual disability (ID). Recent progress in detection and analysis of rare variants allowed to identify group of genes with strong statistical evidence for association with ASD risk, of which TBR1. Numerous studies on mice showed that TBR1 heterozygous mice display autistic traits as deficiencies in social interaction, in cognitive flexibility, and in associative memory. Functional analyses on human cell lines have demonstrated that de novo truncating variants in TBR1 identified in patients with sporadic ASD disrupt transcriptional repression activity, localization, homodimerization of TBR1 product.
In 2019, only 12 single nucleotide variants (SNVs) and few copy number variations (CNVs) involving TBR1 have been reported in the literature and clinical descriptions were poor. To provide details on the phenotype linked to TBR1 mutations, we and others gathered 25 new individuals with de novo TBR1 SNV and CNV, complemented by a review of individuals previously reported in the literature. On 38 individuals, all presented developmental delay (DD)/ID, ranging from mild to severe, and 76% of them presented autistic traits. Additional behaviour disorders were observed in 85% of individuals, mainly attention deficit and aggressive behaviour. However, the natural history of patients with TBR1 variations is not well known.
Development of RNA-Seq allowed a better understanding of its transcription factor role and revealed that Tbr1 promotes expression of layer 6 markers as Wnt7b. In heterozygous and homozygous TBR1 mutant mice, Fazel Darbandi et al (1), observed that Wnt7b expression is reduced in cortical layer 6 and that neurons have reduced excitatory and inhibitory synaptic density. They showed that lithium chloride and lithium carbonate, WNT-signalling agonists, rescue the dendritic spines, the synaptic and the axonal defects in Tbr1layer5, Tbr1layer6 and Tbr1 constitutive (Tbr1+/-) mutant mice. They also observed an improvement of social interactions in mice after treatment by lithium. These results suggest an important and novel biological mechanism underlying ASD that may have implications for the treatment of patients with TBR1 variants.
Moreover, lithium treatment has already been evaluated in patients with neurocognitive disorders not linked to TBR1 showing an improvement in the adaptative behaviour and cognition function.
As of today, only symptomatic treatments are available. As lithium increase neuronal activity in mice, and may thus improve the symptoms of this disorder, we propose a clinical trial to study the security and efficacy of lithium carbonate targeting the patients with TBR1-related disorders, with specific and adapted endpoints. Lithium carbonate treatment will be administered after an observation period of 6 to 12 months, allowing to ascertain the stability of neurocognitive abnormalities.

Start Date01 Feb 2025

Sponsor / Collaborator

Centre Hospitalier Universitaire de Dijon

100 Clinical Results associated with Lithium carbonate

100 Translational Medicine associated with Lithium carbonate

100 Patents (Medical) associated with Lithium carbonate

23,818

Literatures (Medical) associated with Lithium carbonate

01 Dec 2025·Nano-Micro Letters

Photo-Energized MoS2/CNT Cathode for High-Performance Li–CO2 Batteries in a Wide-Temperature Range

Article

Author: Hu, Kang ; Cui, Xueliang ; Lian, Wenyi ; Yao, Tengyu ; Li, Qiuju ; Shen, Laifa ; Hu, Tingsong

Abstract:

Li–CO2 batteries are considered promising energy storage systems in extreme environments such as Mars; however, severe performance degradation will occur at a subzero temperature owning to the sluggish reaction kinetics. Herein, a photo-energized strategy adopting sustainable solar energy in wide working temperature range Li–CO2 battery was achieved with a binder-free MoS2/carbon nanotube (CNT) photo-electrode as cathode. The unique layered structure and excellent photoelectric properties of MoS2 facilitate the abundant generation and rapid transfer of photo-excited carriers, which accelerate the CO2 reduction and Li2CO3 decomposition upon illumination. The illuminated battery at room temperature exhibited high discharge voltage of 2.95 V and mitigated charge voltage of 3.27 V, attaining superior energy efficiency of 90.2% and excellent cycling stability of over 120 cycles. Even at an extremely low temperature of − 30 °C, the battery with same electrolyte can still deliver a small polarization of 0.45 V by the photoelectric and photothermal synergistic mechanism of MoS2/CNT cathode. This work demonstrates the promising potential of the photo-energized wide working temperature range Li–CO2 battery in addressing the obstacle of charge overpotential and energy efficiency.

01 Dec 2025·Nano-Micro Letters

An Efficient Boron Source Activation Strategy for the Low-Temperature Synthesis of Boron Nitride Nanotubes

Article

Author: Zuo, Hui ; Zhou, Zhengyang ; Wang, Ying ; He, Qian ; Songfeng, E ; Ding, Feng ; Zhang, Jin ; Ding, Liping ; Zhang, Kai ; Wu, Liyun ; Hu, Yue ; Wang, Nanyang ; Yao, Yagang

Abstract:

Lowering the synthesis temperature of boron nitride nanotubes (BNNTs) is crucial for their development. The primary reason for adopting a high temperature is to enable the effective activation of high-melting-point solid boron. In this study, we developed a novel approach for efficiently activating boron by introducing alkali metal compounds into the conventional MgO–B system. This approach can be adopted to form various low-melting-point AM–Mg–B–O growth systems. These growth systems have improved catalytic capability and reactivity even under low-temperature conditions, facilitating the synthesis of BNNTs at temperatures as low as 850 °C. In addition, molecular dynamics simulations based on density functional theory theoretically demonstrate that the systems maintain a liquid state at low temperatures and interact with N atoms to form BN chains. These findings offer novel insights into the design of boron activation and are expected to facilitate research on the low-temperature synthesis of BNNTs.

01 Sep 2025·JOURNAL OF THE EUROPEAN CERAMIC SOCIETY

Research on optimizing the crystal structure and enhancing the performance of LLTO solid electrolyte through doping with high-electronegativity Fe3+

Author: Guo, Xu ; Li, Yueming ; Li, Kai ; Kwame, Yadzo Emmanuel ; Yuan, Jiale ; Jiang, Binxuan

The excellent bulk conductivity of the perovskite-type (Li_0.33-xFe_xLa_0.56TiO₃, LLTO) solid electrolyte makes it one of the most valuable solid electrolyte materials.However, in the current research, there are few studies examining how electronegativity factors influence the crystal structure of LLTO.In this paper, the solid phase reaction method was adopted to adjust the lattice structure of the material by the chem. formula Li_0.33-xFe_xLa_0.56TiO₃(x = 0.01, 0.03,0.05, 0.07 mol) by substituting strong electronegativity Fe³⁺ ions for Li⁺ ions in LLTO.The effects of Fe³⁺ con the structure and properties of LLTO were studied.The results show that the addition of Fe³⁺ can successfully replace Li+ in the lattice, effectively improve the cubic phase content, crystal integrity, grain size uniformity and bulk d. of LLTO, and further improve the grain conductance.However, increasing the doping amount of Fe³⁺ c results in excessive unequal substitution, facilitating the formation of many cation vacancies in the lattice which is detrimental to the growth and perfection of cubic crystals.Also, excess Fe³⁺ c causes exaggerated grain growth, reduction of grain size uniformity and the d. of the material, thereby reducing the bulk conductance of the material.In this work, optimal comprehensive performance is achieved when the sample is doped with 0.01 mol of Fe³⁺ c and sintered at 1220 °C for 6 h.The c-LLTO content reaches 93%, bulk d. of 4.75 g cm^-3, and bulk conductivity of 1.42 mS cm^-1 which is 63.22% higher than that of the undoped sample.This study demonstrates that the incorporation of Fe³⁺ significantly enhances the bulk conductivity of the material′s grains.

News (Medical) associated with Lithium carbonate

13 May 2025

·ir.alzamend.com

Alzamend Neuro Initiates First Phase II Clinical Trial of AL001 “Lithium in Brain” Study Taking Place at Massachusetts General Hospital

Topline data expected by year end 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 subjects ATLANTA, May 13, 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 the initiation of the first of five Phase II clinical studies of AL001, with the first study in healthy human subjects. This study follows the successful development of a novel head coil by Tesla Dynamic Coils BV, a key component of the clinical trial. In collaboration with Massachusetts General Hospital as its clinical trial site, Alzamend aims to explore the unique properties of AL001 and its potential to deliver lithium more effectively in the brain compared to marketed lithium salts. The study in healthy human subjects will serve as a baseline and assist Alzamend determine the best path forward in Alzheimer’s, BD, MDD and PTSD patients 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 U.S. Food and Drug Administration-approved lithium salts 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. Since conventional lithium salts are eliminated relatively quickly, multiple administrations throughout the day are required to safely reach therapeutic plasma concentrations. By reducing the systemic burden, Alzamend’s novel AL001 formulation 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 43 million Americans suffering from Alzheimer’s, BD, MDD and PTSD by providing a safer, more effective and user-friendly therapeutic option, potentially reshaping current treatment paradigms and improving patient quality of life substantially.” 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 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 Released May 13, 2025

Phase 2Clinical ResultVaccine

07 May 2025

·www.globenewswire.com

Alzamend Neuro Partners with QMENTA, to Advance AI-Powered Imaging for its Phase II Clinical Trial of AL001 Study to Take Place at Massachusetts General Hospital

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 subjects ATLANTA, May 07, 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 partnership with Mint Labs Inc. d/b/a QMENTA (“QMENTA”), a leading medical imaging artificial intelligence (“AI”) company, to support its five upcoming Phase II clinical trials of AL001 at Massachusetts General Hospital. QMENTA’s cloud-based platform will manage and analyze medical imaging data throughout the trials, ensuring regulatory compliance, enhancing operational efficiency and supporting data management. Their advanced AI solutions will play a critical role in optimizing the imaging workflow across all five clinical studies. In collaboration with QMENTA and Massachusetts General Hospital as its clinical trial site, Alzamend aims to explore the unique properties of AL001 and its potential to deliver lithium more effectively in the brain compared to marketed lithium salts. The study in healthy human subjects will serve as a baseline and assist Alzamend determine the best path forward in Alzheimer’s, BD, MDD and PTSD patients 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 U.S. Food and Drug Administration-approved lithium salts 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. Since conventional lithium salts are eliminated relatively quickly, multiple administrations throughout the day are required to safely reach therapeutic plasma concentrations. By reducing the systemic burden, Alzamend’s novel AL001 formulation 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. “QMENTA has developed an all-in-one management platform for medical imaging clinical trials incorporating advancing AI solutions,” said Stephan Jackman, Chief Executive Officer of Alzamend. “We are thrilled to add QMENTA to the team and have full confidence in their ability encompassing our five phase II clinical studies of AL001. Moreover, this collaboration lays a foundation for future phase III programs and broader clinical deployment of advanced AI-based imaging biomarkers.” “It’s a privilege to collaborate with Alzamend on such groundbreaking work. I truly believe that the right imaging strategy combined with innovative compounds like AL001 will transform how we treat complex neurodegenerative diseases and psychiatric disorders,” said Vesna Prchkovska, Chief Executive Officer of QMENTA. “By applying AI-driven imaging technologies, we believe we can advance safer, more effective treatments that could significantly impact patients with Alzheimer’s, BD, MDD, PTSD, among other diseases.” 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 A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/c01526b6-40ac-41bf-915f-059f857184a3

Phase 2Vaccine

19 Feb 2025

·www.businesswire.com

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

ATLANTA--(BUSINESS WIRE)--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 the completion of a groundbreaking head coil by Tesla Dynamic Coils BV (“Tesla”). The development of the head coil was necessary to facilitate the five upcoming Phase II clinical trials to be conducted by Alzamend. 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 U.S. Securities and Exchange Commission. All filings are available at www.sec.gov and on Alzamend’s website at www.Alzamend.com.

Phase 2Clinical ResultVaccine

100 Deals associated with Lithium carbonate

External Link

KEGG	Wiki	ATC	Drug Bank
D00801	Lithium carbonate	N05AN01	DB14509

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Bipolar I disorder	United States	Hikma Pharmaceuticals USA, Inc.	29 Jan 1982
Bipolar Disorder	United States	Pfizer Inc.	06 Apr 1970
Bipolar Disorder	United States	Solvay Pharmaceuticals, Inc.	06 Apr 1970
Schizoaffective disorder	United States	Solvay Pharmaceuticals, Inc.	06 Apr 1970
Schizoaffective disorder	United States	Pfizer Inc.	06 Apr 1970

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Kleine-Levin Syndrome	Preclinical	European Union	Laboratoires Delbert SAS	16 Aug 2023

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02862210 (Lithium, CTgov)	Phase 2	Frontotemporal Dementia	17	Lithium Carbonate (Lithium Carbonate)	wbxyyeylxs(cizeawlcps) = vwifksznrr feescpipcx (pabpxmrnqy, 1.1) View more	-	03 Feb 2025
NCT02862210 (Lithium, CTgov)	Phase 2	Frontotemporal Dementia	17	Placebo (Placebo)	wbxyyeylxs(cizeawlcps) = hacpecmxiv feescpipcx (pabpxmrnqy, 1.28) View more	-	03 Feb 2025
NCT02918097 (CTgov)	Phase 4	Bipolar Disorder	78	Lithium Carbonate+Risperidone+Nortriptyline+Sertraline	xlkeiibgsv = guoqmhfbpb sbyszxsdrn (jcirscavhb, grnuslduhs - wmjlzitnmj) View more	-	14 Oct 2020
NCT01820624 (Pubmed) Manual	Phase 1	Acute Myeloid Leukemia	9	lithium carbonate+tretinoin	dlvbhwdjqx(llkxxgifcv) = boerznfxdd shuwaeawpu (xdxqevmbjn )	Negative	10 Mar 2020
EANM2019	Not Applicable	Hyperthyroidism	225	Lithium pretreatment + Radioactive Iodine Treatment	yhycmjstaf(jrddfjhnhi) = xsnarcploy yievjnvnuv (augupycmlx, 0.82)	-	18 Sep 2019
EANM2019	Not Applicable	Hyperthyroidism	225	Radioactive Iodine Treatment alone	yhycmjstaf(jrddfjhnhi) = lubnxhxiqw yievjnvnuv (augupycmlx, 0.44)	-	18 Sep 2019
NCT01553916 (CTgov)	Phase 1/2	Small Cell Lung Cancer	19	Prophylactic cranial irradiation+Lithium Carbonate	buwewncamj = uvmzclzbnn opxnwvruez (larvfzzwmt, wbhvvdbzum - ffnvjbkhcy) View more	-	08 Nov 2017
NCT00501540 (CTgov)	Phase 2	Neuroendocrine Tumors	15	Lithium Carbonate	swyaulrxmc = alqjwloznw upzarnrkrb (twdgkgfawy, ctrmetfvwz - entvudpeop) View more	-	03 May 2017
NCT00408681 (GVHD, CTgov)	Not Applicable	Relapsing acute myeloid leukemia \| Marginal zone lymphoma recurrent \| Gestational Trophoblastic Disease ... View more	20	laboratory biomarker analysis+lithium carbonate	rycguqjqhk = hvysqqnyew izynrfmvns (fnkupixjcr, bqlqcmgawg - kqwrfbwtrc)	-	20 Jan 2017
NCT00582712 (CTgov)	Phase 2	Thyroid Cancer, Medullary	5	Lithium carbonate	sqdxmkugoj(zymukknvzw) = eddlyrglwn zrupjzwdhn (dilhpkgwfi, dmilftglff - pxujvzlyxq) View more	-	12 Dec 2016
NCT00240110 (CTgov)	Phase 1/2	Cocaine-Related Disorders \| Bipolar Disorder	152	Lithium Carbonate+Placebo (Lithium Carbonate Add on Placebo)	priwomxddt(muzorzfehi) = timyccsnft zfiqcfxzhg (wndylxzlrt, 29.7) View more	-	17 Oct 2016
NCT00240110 (CTgov)	Phase 1/2	Cocaine-Related Disorders \| Bipolar Disorder	152	Lithium Carbonate+Valproate (Lithium Carbonate Add on Valproate)	priwomxddt(muzorzfehi) = poqkeslwju zfiqcfxzhg (wndylxzlrt, 20.3) View more	-	17 Oct 2016
NCT00750061 (CTgov)	Phase 2	Spinal Cord Injuries	40	Placebo (Placebo)	gexllciwwf(xoopmqltnu) = dqifyqklss rgbjimsajl (axriwrufif, 0.688) View more	-	04 May 2015
NCT00750061 (CTgov)	Phase 2	Spinal Cord Injuries	40	Lithium Carbonate (Lithium Carbonate)	gexllciwwf(xoopmqltnu) = awdlghqxps rgbjimsajl (axriwrufif, 0) View more	-	04 May 2015

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