Alzamend Neuro Initiates Phase II Clinical Study for Bipolar Disorder Treatment
Atlanta, GA, March 04, 2025 – Alzamend Neuro, Inc., a pioneering biopharmaceutical company specializing in the development of innovative treatments for Alzheimer’s disease, bipolar disorder (BD), major depressive disorder (MDD), and post-traumatic stress disorder (PTSD), has declared its intention to initiate a phase II clinical study for AL001, its novel therapeutic candidate for BD. This announcement comes after the successful completion of a crucial head coil test by Tesla Dynamic Coils BV, a vital component of the upcoming clinical trial.
About AL001
AL001 is an intravenous formulation of sodium oligomannate, a first-in-class glycosylated compound designed to target the clearance of beta-amyloid and tau proteins, key contributors to Alzheimer’s disease and neuroinflammation. Alzamend Neuro has previously demonstrated the potential of AL001 for Alzheimer’s treatment in phase II trials. The company is now expanding its focus to BD, a complex and debilitating mental disorder characterized by extreme mood swings and impaired cognitive function.
Clinical Trial Details
The phase II clinical study, which is expected to begin in the third quarter of 2025, will enroll approximately 150 patients diagnosed with BD. The double-blind, randomized, placebo-controlled trial will evaluate the safety, tolerability, and efficacy of AL001 in managing manic and depressive symptoms in patients with BD. The study’s primary outcome measures will include the Young Mania Rating Scale (YMRS) and Montgomery-Asberg Depression Rating Scale (MADRS).
Impact on Individuals with Bipolar Disorder
For individuals living with bipolar disorder, this clinical trial holds significant promise. The condition, which affects approximately 5.7 million adults in the United States alone, often results in chronic and relapsing symptoms that can negatively impact daily life. Current treatments, such as mood stabilizers and psychotherapy, offer only limited relief for some patients. A more effective therapy like AL001 could provide substantial benefits for managing manic and depressive episodes, potentially improving overall quality of life.
Global Implications
The successful development and implementation of AL001 for treating BD could have far-reaching implications for the mental health community and beyond. With an estimated 60 million people worldwide living with bipolar disorder, the impact of an effective treatment could be substantial. Moreover, the potential for repurposing AL001 for other neurological and psychiatric conditions, such as Alzheimer’s disease, MDD, and PTSD, could lead to a more comprehensive approach to addressing these debilitating disorders.
Conclusion
Alzamend Neuro’s decision to initiate a phase II clinical study for AL001 in the treatment of bipolar disorder represents a significant step forward in the quest for more effective therapies for managing this complex and debilitating condition. With the successful completion of a head coil test by Tesla Dynamic Coils BV, the stage is set for a potentially transformative clinical trial. The potential implications for individuals living with bipolar disorder and the global mental health community are vast, with the potential for AL001 to provide substantial benefits for managing manic and depressive episodes and offering hope for a more comprehensive approach to addressing neurological and psychiatric disorders.
- Alzamend Neuro plans to initiate a phase II clinical study for AL001 in the treatment of bipolar disorder in the third quarter of 2025.
- AL001 is an intravenous formulation of sodium oligomannate, a first-in-class glycosylated compound designed to target beta-amyloid and tau proteins.
- The clinical trial will enroll approximately 150 patients diagnosed with bipolar disorder and will evaluate the safety, tolerability, and efficacy of AL001 in managing manic and depressive symptoms.
- Successful development and implementation of AL001 for treating bipolar disorder could have far-reaching implications for the mental health community and beyond.
