Actively Recruiting
A Randomized, Open-label, Two-treatment Crossover Study Comparing Brain and Plasma Pharmacokinetics and Safety of AL001 and Lithium Carbonate in Adults With Bipolar I Disorder
Led by Alzamend Neuro, Inc. · Updated on 2026-04-20
20
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
A
Alzamend Neuro, Inc.
Lead Sponsor
M
Massachusetts General Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new crystallized form of lithium called AL001 in people diagnosed with bipolar I disorder. This study compares the safety and how AL001 is processed and distributed in the brain and body to the commonly used lithium carbonate. The goal is to understand if AL001 may offer a similar or better effect with potentially fewer side effects. Participants will take AL001 and lithium carbonate each for 14 days during two separate treatment periods, with a washout period in between. They will stay overnight at a research center for two separate 2-week periods. During these stays, participants will undergo multiple blood tests and brain MRI scans over 24 hours to observe how each lithium form behaves in the body and brain. Throughout the study, participants will be closely monitored with frequent assessments including physical and neurological exams, vital signs, lab tests, and mental health evaluations. Researchers will measure the pharmacokinetics of AL001 and lithium carbonate in the brain and plasma, safety, and tolerability from enrollment through a follow-up period. The total participation includes two 14-day treatment periods with detailed evaluations during and after dosing.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Ages 18 to 65 years
- Diagnosed with bipolar I disorder based on DSM-5-TR
- In reasonably good physical health
- Stable mood stabilizing medication regimen for more than 30 days or untreated but stable bipolar I disorder
- Young Mania Rating Scale score less than 8 and Hamilton Depression Rating Scale score less than 16
- No significant worsening of depression symptoms in the 4 weeks prior to randomization
- No concerning suicidal ideation or behavior history
- Able to understand and follow study instructions
- Willing to follow study procedures and stay overnight for two 2-week periods
- Any gender, race, or ethnicity
- Able to provide written informed consent in English
- Males must agree to use barrier contraception during the study
- Females of childbearing potential must use acceptable contraception or be of non-childbearing potential
- Body mass index between 18.0 and 31.0 kg/m2 and weight of at least 50 kg
- Normal ECG with no clinically significant abnormalities
You will not qualify if you...
- Clinically significant medical conditions affecting safety or study participation
- History of drug hypersensitivity or severe allergies
- Other disorders preventing study completion
- Severe acute or chronic medical or psychiatric conditions interfering with the study
- History of seizure disorder or severe head trauma (except single childhood febrile seizure)
- Gastrointestinal or liver diseases
- Conditions affecting absorption or metabolism of study drugs
- History of frequent headaches or migraines
- Kidney disease with low filtration rate
- Uncontrolled heart rhythm problems or heart failure
- Active cancer needing chemotherapy or radiation
- Positive HIV, hepatitis B or C tests (unless cleared)
- Severe liver impairment
- Uncontrolled high blood pressure or fever at screening
- Psychiatric or neurological illnesses other than bipolar I disorder
- Treatment with certain antipsychotics or immunosuppressants
- Current hyponatremia during lithium treatment
- Recent use of many medications or supplements except some allowed exceptions
- Recent electroconvulsive therapy
- Unwillingness to avoid certain foods or substances before and during the study
- History of aspirin/nasal polyposis/asthma syndrome
- Pregnancy, breastfeeding, or planning pregnancy
- History of adverse reaction to lithium, aspirin, or study components
- Recent drug or alcohol abuse
- Excessive caffeine consumption or unwillingness to avoid certain foods
- Participation in another investigational drug trial recently
- Untreated thyroid dysfunction
- MRI incompatibility or intolerance
- Past suicide attempts or recent suicidal ideation
- Suspected Brugada Syndrome
- Other central nervous system conditions affecting safety or study results
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Two 14-day treatment periods separated by a washout period
Participants receive two different lithium treatments, AL001 and lithium carbonate, each for 14 days with an intervening washout period. During each 2-week treatment period, participants stay overnight at the study site for frequent blood draws and brain MRI scans to monitor how the medications are processed and reach the brain.
Two 2-week overnight stays at the study site with frequent assessments, including blood draws and brain MRI scans
Duration - Up to 4 weeks after the last treatment period
Participants are monitored for safety and tolerability of the treatments after completing the treatment periods.
Visits as needed for safety monitoring
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
E
Eve del Rio, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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