AL001 for Pharmacokinetics

Overseen By Eve del Rio, MD, PhD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Alzamend Neuro, Inc.

No Placebo Group

Trial Summary

What is the purpose of this trial?

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 Carbonate in healthy volunteers. The main questions this study aims to answer are: How safe and effective is AL001 when compared to Lithium Carbonate? How is AL001 broken down in the brain and body compared to Lithium Carbonate? Participants will be asked to: * Take both the study drug (AL001) and Lithium Carbonate each for a period of 14 days * Stay overnight at MGH's research unit for two separate 2-week periods * Participate in two separate 24 hour periods of multiple MRIs and blood draws

Eligibility Criteria

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.

Treatment Details

Interventions

• AL001 (Other)
• Lithium Carbonate Capsule (Other)

Participant Groups

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+