Alzamend Neuro, Inc. 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. 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. About AL001 Phase IIA Study: Having completed the clinical portion of the MAD study, the resulting pharmacokinetic and statistical data are undergoing evaluation of the safety and tolerability of AL001 under multiple-dose, steady-state conditions.

This is to characterize the maximum tolerated dose in healthy young and elderly subjects and in subjects diagnosed with mild to moderate Alzheimer's. Potentially safe and effective doses will thereby be determined for deployment in planned subsequent Phase IIA clinical trials involving Alzheimer's, bipolar disorder, MDD and PTSD subjects. Lithium has been well-characterized for safety and is approved/marketed in multiple formulations for bipolar affective disorders. AL001 lithium ascending dosing for the MAD cohorts tested incremental fractions of the usual lithium exposure for treatment of bipolar affective disorder, with the target lithium dose for Alzheimer's treatment expected at a level that will not require therapeutic drug monitoring.

In each of the multiple healthy young/elderly and Alzheimer's cohorts, consisting of 6 active and 2 placebo patients each (as per randomization), multiple ascending doses were administered three times daily for 14 days under fasted conditions up to tolerability/safety limits that included the highest dose permitted per protocol.