AL001 for Bipolar Disorder

Overseen By Eve del Rio, MD, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Alzamend Neuro, Inc.

Must be taking: Mood stabilizers

Must not be taking: Haloperidol, MAO inhibitors

Disqualifiers: Seizure disorder, Liver disease, others

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

Compensation: Varies

Number of Visits: 28

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this clinical trial is to assess the safety and effects of a crystallized form of lithium, AL001, when compared to commonly used lithium carbonate in individuals diagnosed with bipolar I disorder. The main questions this study aims to answer are:

* How safe 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.

Are You a Good Fit for This Trial?

Inclusion Criteria

I agree to use barrier contraception during the study until after Day 23.

1. Abstinence from heterosexual intercourse from the Screening visit through to at least 30 days after the last dose of the study drug on Day 14 (P2).

8. Able to understand and provide written informed consent.

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 inpatient stay

Washout

Participants undergo a washout period between treatment periods

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 inpatient stay

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

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+