Alzamend Neuro Inc. has announced the launch of a phase 2A trial for its AL001 treatment for mild to moderate Alzheimer’s dementia.
AL001 is being developed as an oral lithium-based therapy and has the potential to deliver lithium carbonate to the brain while mitigating or avoiding current toxicities associated with lithium.
“Advancing AL001 into a phase 2A clinical trial as planned marks an important milestone for Alzamend,” Alzamend CEO Stephan Jackman said in a released statement. “We are one step closer to proving that AL001 could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating over 40 million Americans suffering from Alzheimer’s and other neurodegenerative diseases and psychiatric disorders.”
The first patient with mild to moderate AD has received a dose of AL001 in a 12-month multiple ascending dose (MAD) study, which will evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determine the maximum tolerated dose in patients diagnosed with AD.
According to the release, lithium has been well-characterized for safety and is currently approved in multiple formulations for the treatment of bipolar affective disorders. Dosing for the MAD study is based on a fraction of the typical lithium dose used in these treatments.
“We look forward to completing the MAD study and further advancing clinical development of this promising potential therapeutic,” Jackman said.