Dosing Begins for Next Phase of Trial for Investigational Therapy AL001
This multiple ascending dose (MAD) part follows positive results from a Phase 1 trial. Topline data from the Phase 2a trial is expected in December.
“Advancing AL001 into a Phase IIA clinical trial as planned marks an important milestone for Alzamend,” Stephan Jackman, CEO of Alzamend, said in a press release.
The Phase 2a (NCT05363293) study, underway at a single U.S. clinical center — the iResearch Atlanta & iResearch Savannah in Georgia — will assess the safety and tolerability of AL001, as well as determine its maximum tolerated dose (MTD).
The trial intends to enroll 40 patients with mild-to-moderate Alzheimer’s, ages 50 to 80. More information about enrollment is available here.
Each dosing group will enroll eight patients, with six assigned randomly to AL001 and two to a placebo, both administered under fasting (at least one hour before or fours hours after meals). Participants will receive increasing doses of AL001 or a placebo for 14 days, three times a day, and will be followed for 42 days after treatment.
AL001 (also known as LiProSal) is an ionic cocrystal of lithium. Specifically, it was designed to deliver lithium using a combination with L-proline and salicylate. In this formulation, lithium should be safer and effective at much lower doses than current lithium-based treatments.
In preclinical studies with mouse models of Alzheimer’s, treatment with AL001 prevented cognitive impairment, depression, and irritability. It also enhanced learning and memory when compared with other lithium formulations.
In the Phase 1 trial, healthy participants received a single dose of AL001 containing lithium in an amount equivalent to 150 milligrams (mg) lithium carbonate. Administration of this dose, three times daily, was established previously as appropriate for Alzheimer’s treatment.
The findings showed that a 150 mg dose of AL001 led to similar levels of lithium in the blood as was a 300 mg capsule of marketed lithium carbonate.
According to Alzamend, these findings support the therapeutic potential of AL001, which, when given at a much lower dose, may help reduce the risk of potential side effects. Moreover, it will eliminate the need for frequent monitoring of lithium levels in patients’ blood.
“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,” said Jackman.
“We look forward to completing the MAD study and further advancing clinical development of this promising potential therapeutic,” he added.