LISPRO (lithium/proline/salicylate) / Alzamend Neuro - LARVOL DELTA

A 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 (clinicaltrials.gov) - P1 | N=6 | Not yet recruiting | Sponsor: Alzamend Neuro, Inc.

New P1 trial

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 (GlobeNewswire) - "Alzamend Neuro...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....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."

New P2 trial • Alzheimer's Disease

Alzamend Neuro Announces Initiation Date of Phase II Clinical Trial of AL001 for Treatment of Major Depressive Disorder to take Place at Massachusetts General Hospital (GlobeNewswire) - "Alzamend Neuro, Inc...today announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment of patients with MDD 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."

New P2 trial • Major Depressive Disorder

Alzamend Neuro Announces Initiation Date of Phase II Clinical Trial of AL001 for Treatment of Post-Traumatic Stress Disorder to take Place at Massachusetts General Hospital (GlobeNewswire) - "Alzamend Neuro, Inc...announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment of patients with PTSD 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."

New P2 trial • Post-traumatic Stress Disorder

Alzamend Neuro Announces Initiation Date of Phase II Clinical Trial of AL001 for Treatment of Bipolar Disorder to take Place at Massachusetts General Hospital (GlobeNewswire) - "Alzamend Neuro, Inc...today announced its plans to initiate a highly anticipated phase II clinical study of AL001 for treatment of patients with BD, which is expected to commence in the third quarter of 2025....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."

New P2 trial • Bipolar Disorder

Alzamend Neuro Announces Initiation Date of First Phase II Clinical Trial of AL001 to take Place at Massachusetts General Hospital (GlobeNewswire) - "Alzamend Neuro, Inc...announced its plans to initiate the first of five highly anticipated phase II clinical studies of AL001, with the first study, in healthy human subjects, expected to commence in the second quarter of 2025. This study follows the successful development of a novel head coil by Tesla Dynamic Coils BV, a key component of the clinical trial....The study in healthy human subjects will serve as a baseline and could illuminate the 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."

New P2 trial • Alzheimer's Disease • Bipolar Disorder • Major Depressive Disorder • Post-traumatic Stress Disorder

Alzamend Neuro to Present Non-Clinical Data Update at the Society of Toxicology 2025 Annual Meeting and ToxExpo (Businesswire) - "Alzamend Neuro, Inc...today announced it will have a poster presentation at the Society of Toxicology ('SOT') Annual Meeting and ToxExpo, being held from March 16-20, 2025, in Orlando, Florida. 'Our poster presentation at SOT in 2025 with data from our non-clinical study: Comparing Brain and Plasma Lithium Exposures between AL001 and Lithium Carbonate in Alzheimer’s Transgenic Mice, demonstrates the potential of AL001 to enhance brain-specific lithium delivery while minimizing systemic exposure in an Alzheimer’s disease mouse model, guiding development of enhanced lithium effectiveness and safety in human diseases,'...'Following successful results from this study and our Phase I and IIA trials, AL001 is positioned for five Phase II trials in partnership with Massachusetts General Hospital in 2025.'"

New trial • Preclinical • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Major Depressive Disorder • Post-traumatic Stress Disorder

Alzamend Neuro Announces Full Data Set from its Nonclinical Study: Comparing Brain and Plasma Lithium Exposures between AL001 and Lithium Carbonate in Alzheimer’s Transgenic Mice (Businesswire) - "Alzamend Neuro, Inc...today announced that it has finished analyzing the final full data set from a nonclinical study comparing brain and plasma lithium exposures between AL001 and lithium carbonate in Alzheimer’s transgenic mice...No Undue Adverse Effects: Both treatments had no negative impact on the mice's body weight or clinical signs during the treatment period. Reduced Systemic Exposure: AL001 showed lower plasma lithium levels than lithium carbonate, reducing the risk of adverse systemic effects, suggesting an expansion for safety of lithium’s therapeutic index. Enhanced Brain Penetration: AL001 showed consistently higher lithium concentrations in brain tissues, particularly at lower doses, compared to lithium carbonate. Targeted Brain Structures: The study found that different brain regions absorb and retain lithium differently."

Preclinical • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Announces Full Data Set from Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s (Businesswire) - P1/2a | N=65 | NCT05363293 | Sponsor: Alzamend Neuro, Inc. | "Alzamend Neuro, Inc...announced that it has received the final full data set from its multiple ascending dose clinical trial for AL001 treatment of dementia related to Alzheimer’s....The safety profile was demonstrated to be benign at all dose levels, and so the selected dose level chosen for further development was based on avoidance of plasma drug concentrations associated in the medical literature with exceeding the upper limit of the therapeutic range of drug concentrations, thereby serving to mitigate potential toxicity; Under the conditions of this study, multiple dose administrations of AL001 were well tolerated in healthy elderly and non-elderly subjects, and in subjects with Alzheimer’s, regardless of their comorbidities."

P2a data • Alzheimer's Disease • Dementia

Alzamend Neuro Partners with Massachusetts General Hospital for a Phase II Clinical Trial of AL001, a Next-Generation Lithium Therapeutic Drug Candidate, involving Patients with Alzheimer’s Disease (Businesswire) - "Alzamend Neuro, Inc...today announced that it is partnering with Massachusetts General Hospital ('Mass General') as its contract research organization ('CRO') to conduct a Phase II clinical trial of AL001 for treatment of patients with Alzheimer’s. A healthy subjects cohort will also be studied to permit comparisons of their plasma and brain pharmacokinetics to that of patients with Alzheimer’s."

Licensing / partnership • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in Post-Traumatic Stress Disorder Patients of Next‑Generation Lithium Therapeutic Drug Candidate AL001 (Businesswire) - "Alzamend Neuro, Inc...announced that it has submitted an investigational new drug ('IND') application to the U.S. Food and Drug Administration ('FDA') for the initiation of study AL001-PTSD01, a Phase IIA plasma/brain pharmacokinetics clinical study of AL001 for treatment of patients with PTSD."

IND • CNS Disorders • Post-traumatic Stress Disorder

Alzamend Neuro Submits IND Application for a Phase IIA Clinical Trial in Major Depressive Disorder Patients of its Next‑Generation Lithium Therapeutic Drug Candidate AL001 (Businesswire) - "Alzamend Neuro, Inc...today announced that it has submitted an investigational new drug ('IND') application to the U.S. Food and Drug Administration ('FDA') for the initiation of study AL001-MDD01, a Phase IIA plasma/brain pharmacokinetics clinical study of AL001 for adjunctive treatment of patients with MDD....After receipt of a 'study may proceed' communication from the FDA, Alzamend plans to initiate a Phase IIA study to characterize AL001 improvements of lithium levels in the brain compared to a marketed lithium salt in MDD patients. Alzamend anticipates that this program may, based on safety, qualify for a 505(b)(2) NDA pathway to FDA approval, which is available to new formulations of an approved drug."

IND • New P2a trial • CNS Disorders • Depression • Major Depressive Disorder

Alzamend Neuro Receives FDA “Study May Proceed” Notification for a Phase IIA Clinical Trial of AL001, a Next-Generation Lithium Therapeutic Drug Candidate, in Bipolar Disorder Patients (Businesswire) - "Alzamend Neuro, Inc...today announced receipt of a 'Study May Proceed' letter from the U.S. Food and Drug Administration ('FDA') for the initiation of study AL001-BD01, a Phase IIA clinical study of AL001 for BD type 1....'We are advancing the process and expect that the first patient will be dosed in the first quarter of 2024.'"

IND • New P2a trial • Bipolar Disorder • CNS Disorders

MAD: Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects (clinicaltrials.gov) - P1/2 | N=65 | Completed | Sponsor: Alzamend Neuro, Inc. | Active, not recruiting ➔ Completed | Trial completion date: Oct 2023 ➔ May 2023

Trial completion • Trial completion date • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Announces Positive Phase IIA Clinical Trial Results for AL001 (Businesswire) - P2a | N=72 | NCT05363293 | Sponsor: Alzamend Neuro, Inc. | "Alzamend Neuro...today announced that it has successfully identified a maximum tolerated dose ('MTD') for development of AL001 from a multiple-ascending dose study as assessed by an independent safety review committee...Also, this MTD is risk mitigated for the purpose of treating fragile populations, such as Alzheimer’s patients....'We look forward to further evaluating AL001 in two Phase II clinical trials for patients with mild to moderate Alzheimer’s, of which we anticipate initiating both by the first quarter of 2024, and exploring the potential for AL001 for patients suffering from BPD, MDD and PTSD by submitting investigational new drug applications to the FDA for these indications by the end of 2023."

IND • New P2 trial • Alzheimer's Disease • Bipolar Disorder • CNS Disorders • Depression • Post-traumatic Stress Disorder • Tauopathies And Synucleinopathies

Altasciences Completes Clinical Portion of Alzamend Neuro’s Phase IIa Multiple Ascending Dose Clinical Trial for Treatment of Dementia Related to Alzheimer’s (Businesswire) - "Altasciences is proud to support Alzamend Neuro, Inc...In addition to having conducted Alzamend’s Phase IIa multiple ascending dose (MAD) clinical trial in healthy subjects, Altasciences is continuing to provide clinical monitoring, project management, biostatistics, pharmacokinetics (PK), bioanalysis, and medical writing solutions as the product candidate is evaluated in Alzheimer’s patients....The purpose of the MAD study conducted at Altasciences’ Montréal clinical pharmacology unit, was to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions; to determine the maximum tolerated dose in healthy young and elderly study participants; and to allow Alzamend to proceed to the next step: dosing in planned subsequent Phase IIa clinical trials involving Alzheimer’s, bipolar disorder, major depressive disorder (MDD), and post-traumatic stress disorder (PTSD) subjects."

Trial status • Alzheimer's Disease • CNS Disorders • Dementia

MAD: Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects (clinicaltrials.gov) - P1/2 | N=72 | Active, not recruiting | Sponsor: Alzamend Neuro, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Announces Completion of Clinical Portion of Phase IIA Multiple Ascending Dose Clinical Trial for AL001 Treatment of Dementia Related to Alzheimer’s (Businesswire) - “Alzamend Neuro…announced the completion of the clinical portion of its Phase IIA multiple ascending dose (‘MAD’) study for dementia related to Alzheimer’s. The MAD study’s purpose was to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose in patients diagnosed with mild to moderate Alzheimer’s and healthy subjects….‘We look forward to reporting topline data in June 2023 and further advancing clinical development of this promising potential therapeutic.’”

P2a data • Trial status • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Reports Third Fiscal Quarter Financial Results and Provides a Business Update (Businesswire) - “Initiation of Phase I/IIA Clinical Trial for ALZN002 to Treat Mild to Moderate Dementia of the Alzheimer’s Type Expected in March 2023. Topline Data from Phase IIA Multiple Ascending Dose Clinical Trial for AL001 in Treatment of Dementia Related to Alzheimer’s Expected in June 2023.”

New P1/2 trial • P2a data • Alzheimer's Disease • CNS Disorders

MAD: Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects (clinicaltrials.gov) - P1/2 | N=72 | Recruiting | Sponsor: Alzamend Neuro, Inc. | Trial completion date: May 2023 ➔ Oct 2023 | Trial primary completion date: Dec 2022 ➔ Apr 2023

Trial completion date • Trial primary completion date • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Partners With the Miller School of Medicine, Interdisciplinary Stem Cell Institute at the University of Miami for ALZN002 Phase I/IIA Immunotherapy Vaccine Clinical Trial to Treat Mild to Moderate Dementia of the Alzheimer’s Type (Businesswire) - "Alzamend Neuro, Inc...announced that it is partnering with the Miller School of Medicine, Interdisciplinary Stem Cell Institute at the University of Miami for its Phase I/IIA clinical trial of 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....'We are advancing the process and expect to initiate this study in the first quarter of 2023'....'We look forward to reporting topline data from the Phase IIA MAD study in the second quarter of 2023...'"

Licensing / partnership • New P1/2 trial • P2a data • Alzheimer's Disease • CNS Disorders

MAD: Multiple Ascending Dose Safety, Tolerability, Pharmacokinetic Study of AL001 in Patients With Alzheimer's Disease and Healthy Adult Subjects (clinicaltrials.gov) - P1/2 | N=72 | Recruiting | Sponsor: Alzamend Neuro, Inc. | N=40 ➔ 72

Enrollment change • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Announces Addition of Healthy Subjects to Ongoing Phase IIA Clinical Trial for AL001 in Alzheimer’s Subjects (Businesswire) - "Alzamend Neuro, Inc…announced it has dosed its first healthy adult subject in its Phase IIA multiple ascending dose (‘MAD’) study of AL001 in subjects with dementia related to Alzheimer’s. This blinded, placebo-controlled trial (AL001-02) was initiated in May 2022 and is designed to evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose….‘Adding healthy adult and elderly subjects to the Phase IIA MAD clinical trial is in response to recent FDA guidance regarding our forthcoming INDs for AL001 as a treatment of bipolar disorder, MDD and PTSD…’"

Trial status • Alzheimer's Disease • CNS Disorders

Alzamend Neuro Announces Pre-IND Submission for AL001 as a Treatment of Bipolar Disorder, Major Depressive Disorder and Post-Traumatic Stress Disorder (Businesswire) - "Topline data expected in December 2022 from ongoing Phase IIA multiple ascending dose clinical trial for AL001 treatment of dementia related to Alzheimer’s...Alzamend Neuro, Inc...announced that it has submitted a Pre-IND (investigational new drug) meeting request for AL001 and supporting briefing documents to the U.S. Food and Drug Administration ('FDA') for the treatment of bipolar disorder, major depressive disorder and post-traumatic stress disorder ('PTSD')."

FDA event • P2a data • Alzheimer's Disease • CNS Disorders

"MAD": Multiple Ascending Dose Safety, Tolerability, Pharmacokinetic Study of AL001 in Patients With Alzheimer's Disease (clinicaltrials.gov) - P1/2 | N=40 | Recruiting | Sponsor: Alzamend Neuro, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Alzheimer's Disease • CNS Disorders