RecruitingNCT07540338
AL001 versus lithium carbonate in bipolarity type I
Researchers are comparing lithium levels in the brain and blood after AL001 and immediate-release lithium carbonate, and assessing safety in adults with bipolarity type I.
Medication studyAges 18–65United States
Understand this study
Who could participate?
Listed age limits: 18 years to 65 years.
- Listed locations
- BostonSee all locations and recruitment
- Study phase
- Phase 1 / Phase 2This study spans more than one phase, so it may combine goals such as safety, dosing, and early effectiveness.
What to know before participating
A point to clarify
This summary does not cover all risks or eligibility requirements. What risks or changes to my care would apply to me?
Things to check before joining
Study start dateStarted: May 11, 2026
- Recruitment status
- Recruiting
- Enrollment listed in the registry
- 20
- Sponsor
- Alzamend Neuro, Inc.
- Sponsor type
- Other organization
- Study type
- Drug
- Intervention type
- Medication / drug
- Study phase
- Phase 1 / Phase 2This study spans more than one phase, so it may combine goals such as safety, dosing, and early effectiveness.
- Locations
- United States
- Age range
- From 18 Years to 65 Years
- Official registry ID
- NCT07540338
- Official title
Show the full official title
A Randomized, Balanced, Phase 1/2A, Multiple-dose, Open-label, Two-treatment, Two-period, Two-sequence, Crossover, Relative Bioavailability Study to Investigate Lithium Brain/Plasma Pharmacokinetics and Safety of an AL001 Oral Capsule Compared to a Marketed Immediate-release Lithium Carbonate Capsule in Subjects With Bipolar I Disorder
Recruitment & locations
RecruitingBoston
A listed location does not confirm current availability.
Questions about this study
Who is behind this study?
The study sponsor is Alzamend Neuro, Inc.
Does this study involve medication?
Yes. The study involves medication, including AL001 and Lithium carbonate.
Who can participate?
Listed age limits: 18 years to 65 years.
Is this study still recruiting?
The registry lists this study as recruiting.
