Oral lithium-based therapy for Alzheimer's shows promise in phase 2 A trial
A phase 2A trial for its AL001 treatment for mild to moderate Alzheimer's dementia has been launched by Alzamend Neuro Inc.
The company is developing AL001 as an oral lithium-based therapy that has the potential to deliver lithium carbonate to the brain while mitigating or avoiding current toxicities associated with lithium.
The company has announced that the first patient with mild to moderate Alzheimer's disease ("Alzheimer's") has been dosed in a 12-month Phase IIA multiple ascending dose ("MAD") study for dementia related to Alzheimer's.
The MAD study is for the purpose of evaluating the safety and tolerability of AL001 under multiple-dose, steady-state conditions and determining the maximum tolerated dose in patients diagnosed with mild to moderate Alzheimer's.
AL001 is a novel lithium-delivery system; it is a lithium-salicylate-L-proline engineered ionic cocrystal under development as an oral treatment for patients with dementia related to mild, moderate, and severe cognitive impairment associated with Alzheimer's. AL001 has the potential to deliver benefits of marketed lithium carbonate while mitigating or avoiding current toxicities associated with lithium.
"Advancing AL001 into a Phase IIA clinical trial as planned marks an important milestone for Alzamend," said Stephan Jackman, Chief Executive Officer of Alzamend. "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 Phase IIA study will 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. Lithium has been well characterized for safety and is approved/marketed in multiple formulations for bipolar affective disorders. Lithium dosing for the MAD cohorts is based on a fraction of the usual dose for treatment of bipolar affective disorder (i.e., AL001 lithium content at a lithium carbonate equivalent of 300 mg 3-times daily ("TID"), daily total of 900 mg), with the target dose for Alzheimer's treatment at half of that lithium carbonate equivalent value (150 mg TID, daily total of 450 mg).
We look forward to completing the MAD study and further advancing clinical development of this promising potential.
