On Wednesday, Alzamend Neuro, Inc. ALZN stated it acquired the ultimate full knowledge set from its a number of ascending dose medical trial for AL001 for dementia associated to Alzheimer’s. Preliminary outcomes have been launched in June 2023.
Recognized by an impartial security assessment committee, this MTD represents a pivotal step ahead; it delivers lithium at a lithium carbonate equal dose of 240 mg, taken thrice each day (TID).
The Section 2A examine evaluated the protection and tolerability of AL001 below multiple-dose, regular‑state circumstances.
It decided the MTD in sufferers recognized with gentle to average Alzheimer’s illness and in wholesome non-elderly and aged topics with satisfactory renal operate.
Lithium has been nicely characterised for security and is authorised and marketed in a number of formulations for bipolar dysfunction.
- The security profile was demonstrated to be benign in any respect dose ranges. The dose degree chosen for additional growth was primarily based on avoiding plasma drug concentrations related within the medical literature with exceeding the higher restrict of the therapeutic vary of drug concentrations, thereby mitigating potential toxicity.
- Underneath the circumstances of this examine, multiple-dose administrations of AL001 have been nicely tolerated in wholesome aged and non-elderly topics, in addition to in topics with Alzheimer’s, no matter their comorbidities.
- No clinically apparent or related lithium or salicylate pharmacokinetic variations have been noticed between non-elderly and aged wholesome topics, or Alzheimer’s topics below the circumstances of this examine.
Primarily based on the outcomes from this examine, Alzamend plans to provoke 5 medical trials to find out the relative elevated lithium ranges within the mind in comparison with a marketed lithium salt for wholesome topics and sufferers recognized with gentle to average Alzheimer’s, bipolar dysfunction, main depressive dysfunction and post-traumatic stress dysfunction, primarily based on revealed mouse research that predict that lithium may be given at decrease doses for equal therapeutic profit when treating with AL001.
In August, Alzamend Neuro completely advised Benzinga that it partnered with Massachusetts Normal Hospital as its contract analysis group to conduct a Section 2 trial to evaluate the comparative enhance in lithium ranges throughout the mind and its constructions versus a generally marketed lithium salt amongst Alzheimer’s sufferers and wholesome topics.
Value Motion: ALZN inventory closed at $1.67 on Tuesday.
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