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Innovative Treatment for Dementia Related to Alzheimer’s Completes Phase 2a Study

March 22, 2023 • 10:15 am CDT
by Gerd Altmann
(Precision Vaccinations)

Alzamend Neuro, Inc. today announced the completion of the clinical portion of its Phase IIA multiple ascending dose ("MAD") study for dementia related to Alzheimer's.

The topline data is expected to be disclosed in June 2023.

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 can potentially deliver the benefits of marketed lithium carbonate while mitigating or avoiding current toxicities associated with lithium.

"We strongly believe that AL001's patented ionic cocrystal technology could potentially provide clinicians with a major improvement over current lithium-based treatments and may constitute a means of treating over 40 million American suffering from Alzheimer's, bipolar disorder, MDD, and PTSD," said Stephan Jackman, Chief Executive Officer of Alzamend, in a press release on March 22, 2023.

"We look forward to reporting topline data in June 2023 and further advancing clinical development of this promising potential therapeutic."

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 characterizes the maximum tolerated dose in healthy young and elderly subjects and subjects diagnosed with mild to moderate Alzheimer's.

Potentially safe and effective doses will 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 the 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.

As of March 22, 2023, there are no approved vaccines targeting Alzheimer's disease.