A 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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Alzamend Neuro, Inc.
Study ID
NCT07540338
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • AL001 — DRUG
    Crystallized lithium
  • Lithium carbonate — DRUG
    Lithium carbonate

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Apr 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Other: Sequence 1: AL001 then lithium carbonate
    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.
  • Other: Sequence 2: Lithium carbonate then AL001
    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.

Primary Outcome Measure

To evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule. [ Time Frame: From time zero to the end of the 24 hour 3-dose interval at steady state. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Study Coordinator
[email protected]
617-724-9602
Ovidiu Andronesi, PhD, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Boston, MA

By condition
Bipolar disorder
By specialty
PsychiatryMental healthBehavioral health
By research site
Massachusetts General Hospital· Boston, MA

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