Q&A: Head coil aims to assist treatment for Alzheimer’s, bipolar, PTSD, depression

Key takeaways:

• Tesla Coil may offer therapeutic drug monitoring for those with certain neuropsychiatric conditions.
• Alzamend Neuro will use the device to measure lithium absorption of a novel therapeutic in phase 2 studies.

Earlier this year, Alzamend Neuro announced the completion of a device designed by Tesla Dynamic Coils, to monitor lithium levels in the brain, which will help researchers identify therapeutic target doses for a range of neuropsychiatric conditions.

Healio spoke to Stephan Jackman, CEO of Alzamend, to find out more about the device and how it applies to the company’s pending phase 2 clinical trials investigating a novel lithium compound, AL001, in patients with Alzheimer’s disease (AD), bipolar disorder, PTSD and major depressive disorder (MDD).

Healio: Describe the process of creating the head coil, from initial conceptualization to its final form.

Jackman: Researchers found that AL001, a lithium salicylate/L-proline co-crystal, results in lower peak plasma lithium concentrations while maintaining therapeutic levels in the brain. It also reduced Alzheimer's-related behavioral deficits better than lithium carbonate, which is FDA approved for bipolar disorder.

This is part of their goal, to create lithium-sparing treatments for AD, bipolar disorder, MDD and PTSD. AL001 showed improved brain penetration and persistence over lithium carbonate in mice, but a noninvasive human method was needed to confirm these findings. Collaborating with Massachusetts General Hospital and Tesla, they developed an MRI specialty coil to noninvasively measure lithium in human brain structures, aiming to apply the initial positive results to human patients.

Healio: How does the head coil work?

Jackman: The MRI coil measures lithium concentration in tissues by utilizing the magnetic properties of lithium nuclei, specifically their “spin,” which makes them act like tiny magnets. In a strong magnetic field, these nuclei align with the field. When a radiofrequency pulse is applied, the nuclei absorb energy and shift their alignment. As the pulse is switched off, they return to their original alignment, releasing energy that the MRI coil detects. Simultaneously, imaging of hydrogen atoms helps identify specific brain structures, enabling detailed comparisons of lithium absorption and retention in those regions.

Healio: Discuss the relationship between the device, AL-001 and Alzamend’s pending phase 2 clinical trials.

Jackman: The phase 2 trials aim to compare how well AL001 and marketed lithium carbonate are absorbed and retained in specific brain structures. Key areas of interest in planned human studies include the amygdala, hippocampus, prefrontal cortex and entorhinal cortex.

The Tesla Coil is specially designed to offer the high level of precision needed for these measurements. This setup is expected to enable detailed comparisons between AL001 and lithium carbonate in humans, including both healthy individuals and those with AD, bipolar disorder, MDD and PTSD.

Healio: Can you describe the format for each of the proposed clinical trials?

Jackman: Each participant will receive AL001 for 14 days and a marketed lithium carbonate product with the same lithium content for another 14 days. The order in which these treatments are given will be randomly assigned.

On the 14th day of each treatment, lithium levels in both blood plasma and brain tissues will be measured at several intervals over a 24-hour period to assess how lithium concentrations in the plasma compare to those in brain structures.

The findings are anticipated to help determine the appropriate dose levels for safe and effective treatments. It is expected that AL001 will require lower oral lithium doses than lithium carbonate to achieve sufficient brain lithium concentrations, thereby reducing unnecessary exposure to lithium in vulnerable organs like the thyroid gland and kidneys, minimizing the risk of toxicity.

Healio: How will the head coil assist in diagnosis and treatment of a range of neuropsychiatric conditions?

Jackman: It is, in the near term, expected to advance lithium neuroscience research by helping to assure adequate absorption and persistence in the target organ for efficacy, the brain, during planned clinical efficacy and safety trials.

For the treatment of bipolar disorder type 1, it is notable that currently marketed lithium products require routine monitoring of lithium concentrations in blood to maintain the trough values (the day’s lowest concentrations) in a narrow therapeutic range (eg, 0.8 to 1.2 mEq/L).

This monitoring is currently required to avoid toxicity (when above 1.2 mEq/L) and to avoid loss of effectiveness (when below 0.8 mEq/L). Routine lithium blood monitoring is mandatory, per lithium carbonate and lithium citrate product package inserts. AL001 is expected to obviate the need for routine monitoring of lithium in blood by lowering and widening the acceptable therapeutic range of lithium blood concentrations.

When delivered by AL001, a lower oral lithium dose would be needed to achieve adequate brain lithium concentrations. The likelihood of blood lithium concentrations rising to above 1.2 mEq/L would thereby be reduced, obviating the need for routine safety monitoring in most patients, i.e., those with adequate renal function.

For the intermediate and long term, the Tesla Coil has the potential to offer nonmandatory therapeutic drug monitoring in patients to help assure clinical effectiveness by measuring if there are adequate lithium concentrations in targeted, disease-specific brain structures during treatment. This could help clinicians optimize their patients’ treatment outcomes by providing evidence that they are receiving appropriate drug doses, or that they require treatment modifications.

Reference:

• Alzamend Neuro announces completion of a novel head coil by Tesla for measuring brain structure lithium levels in five upcoming phase 2 clinical trials at Massachusetts General Hospital. https://ir.alzamend.com/news-events/press-releases/detail/83/alzamend-neuro-announces-completion-of-a-novel-head-coil-by. Published Feb. 19, 2025. Accessed March 13, 2025.