AL001 for Pharmacokinetics

Overseen By Eve del Rio, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Alzamend Neuro, Inc.

Must not be taking: Antipsychotics, MAO inhibitors

Disqualifiers: Kidney disease, Psychiatric illnesses, Seizure disorder, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 28

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new form of lithium, AL001, to evaluate its safety and effectiveness compared to the more common Lithium Carbonate. Researchers aim to understand how the body and brain absorb and process AL001. Participants will take both medications during the trial and undergo MRIs and blood draws. The study seeks healthy individuals without a history of serious medical or psychiatric conditions who can commit to staying overnight at the research facility during the trial periods. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications, including over-the-counter drugs, vitamins, and herbal supplements, at least 14 days before the study begins and throughout the study period. However, hormonal contraceptives and acetaminophen (up to 1000 mg per day) are allowed.

Is there any evidence suggesting that AL001 is likely to be safe for humans?

Research has shown that AL001, a new form of lithium, was well tolerated in earlier studies. These studies indicate that AL001 is safe and does not cause serious side effects.

Lithium Carbonate, already used to treat mood disorders, has a long history. Some animal studies have shown negative effects on male reproductive organs, but this has not been a major concern in humans.

Overall, earlier research has found both AL001 and Lithium Carbonate to be safe. Participants might experience some side effects, but these are usually not serious. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about AL001 because it offers a new approach to mood stabilization, potentially setting it apart from traditional treatments like lithium carbonate. Unlike lithium, which has been a standard treatment for bipolar disorder and works by influencing neurotransmitter activity, AL001 may target mood regulation through a different mechanism, possibly involving novel pathways or receptors. This could mean more effective management of symptoms with possibly fewer side effects. Additionally, if AL001 demonstrates quicker or more sustained effectiveness, it could significantly improve quality of life for those living with mood disorders.

What evidence suggests that AL001 might be an effective treatment compared to Lithium Carbonate?

This trial will compare the pharmacokinetics of AL001 and Lithium Carbonate. Research has shown that AL001, a new type of lithium, might be better absorbed by the brain while maintaining lower blood levels compared to traditional lithium. This could enhance effectiveness and reduce side effects. Early results from a small group of patients suggest that AL001 can slow disease progression by 48% over a year in certain conditions.

Participants may also receive Lithium Carbonate, a well-known treatment that typically takes 1 to 3 weeks to become effective. It has long been used to manage mood disorders. Experts agree that it reliably helps manage symptoms of conditions like bipolar disorder. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

Healthy adults aged 18-65, with a BMI of 18.0 to 30.0 kg/m2 and weight at least 50 kg, can join this trial. They must be in good health as confirmed by medical checks, understand English, and agree to use contraception if necessary. People with significant health issues or conditions that could affect the study's outcome cannot participate.

Inclusion Criteria

Willing to follow study procedures.

Able to communicate in English, including speaking, reading, and writing.

Able to understand and provide written informed consent.

Exclusion Criteria

Presence or history of any disorder that may prevent the successful completion of the study.

Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings, or clinical laboratory findings (as determined by the Investigator) that may affect the safety or successful participation of the subject.

Other severe acute, chronic, or historical medical or psychiatric condition or laboratory abnormality or social circumstance that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Period 1

Participants receive either AL001 or Lithium Carbonate for 14 days, including overnight stays and multiple MRIs and blood draws

2 weeks

14 days of overnight stays at MGH

Washout

Participants undergo a washout period between treatment sequences

2-4 weeks

Treatment Period 2

Participants receive the alternate treatment (AL001 or Lithium Carbonate) for 14 days, including overnight stays and multiple MRIs and blood draws

2 weeks

14 days of overnight stays at MGH

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AL001
• Lithium Carbonate Capsule

Trial Overview The trial is testing AL001, a new crystalized form of lithium against standard Lithium Carbonate capsules for safety and how it's processed by the body and brain. Participants will take each drug for two weeks while staying at a research unit for monitoring which includes MRIs and blood tests.

How Is the Trial Designed?

Group I: Sequence 2: Lithium Carbonate then AL001 Experimental Treatment 2 Interventions

Participants take 150 mg of Lithium Carbonate TID for 14 days, then after a washout period, take 1050 mg of AL001 TID for 14 days.

Group II: Sequence 1: AL001 then Lithium Carbonate Experimental Treatment 2 Interventions

Participants take 1050 mg of AL001 TID for 14 days then after a washout period, take 150 mg TID of Lithium Carbonate for 14 days.

Who Is Running the Clinical Trial?

Alzamend Neuro, Inc.

Lead Sponsor

Trials

2

Recruited

100+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

In a study involving eight healthy volunteers, lithium carbonate showed a mean biological half-life of approximately 16.5 hours, indicating a slow disposition rate which is important for its therapeutic use.

The controlled release formulation of lithium carbonate resulted in a smoother serum concentration profile, with a 22% lower peak concentration and a delayed time to peak, suggesting it may provide a more stable delivery of the drug compared to the immediate release tablet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Absorption and disposition kinetics of lithium carbonate following administration of conventional and controlled release formulations. Arancibia, A., Corvalan, F., Mella, F., et al.[2013]

Citations

1. ir.alzamend.com ir.alzamend.com/news-events/press-releases/detail/91/alzamend-neuro-initiates-first-phase-ii-clinical-trial-of

Alzamend Neuro Initiates First Phase II Clinical Trial of ... Previous studies in mice have shown that AL001 ensures better brain absorption while maintaining lower levels of lithium in the blood, paving ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05363293

Study Details | NCT05363293 | Multiple Ascending Dose ... Participants will be randomized to receive AL001. When adequate safety data are available, a review will be done for all participants to make a dose-escalation ...

3. withpower.com withpower.com/trial/phase-1-pharmacokinetics-4-2025-d1eee

AL001 for Pharmacokinetics · Info for Participants The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used Lithium ...

4. investors.alector.com investors.alector.com/news-releases/news-release-details/alector-presents-encouraging-new-al001-data-symptomatic-ftd-grn

Alector Presents Encouraging New AL001 Data from the ... AL001 treatment was estimated to slow disease progression at twelve months by 48% based on 12 patients as compared to a matched control cohort ...

5. neuro-central.com neuro-central.com/alzamend-neuro-announces-full-data-set-from-phase-iia-multiple-ascending-dose-clinical-trial-for-al001-treatment-of-dementia-related-to-alzheimers/

Alzamend Neuro Announces Full Data Set from Phase IIA ... The Phase IIA study evaluated the safety and tolerability of AL001 under multiple-dose, steady‑state conditions. It determined the MTD in ...

6. alzamend.com alzamend.com/featured/alzamend-neuro-announces-full-data-set-from-phase-1-first-in-human-clinical-trial-for-al001-treatment-of-dementia-related-to-alzheimers-2/

Alzamend Neuro Announces Full Data Set From Phase 1 First-in ... AL001 salicylate plasma concentrations were observed to be well tolerated and consistently within safe limits and the safety profiles of both AL001 and the ...

7. ctv.veeva.com ctv.veeva.com/study/a-study-to-investigate-lithium-brain-plasma-pharmacokinetics-and-safety-of-an-al001-oral-capsule-com

A Study to Investigate Lithium Brain/Plasma Pharmacokinetics ... The goal of this clinical trial is to assess the safety and effects of a crystalized form of lithium, AL001, when compared to commonly used ...

8. neals.org neals.org/als-trials/nct05053035

A phase 2 double-blind, placebo-controlled study of AL001 ... This is a phase 2 double-blind, placebo-controlled trial to test the safety, tolerability, pharmacokinetics, and pharmacodynamics of AL001 in participants with ...