Actively Recruiting
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
Led by Alzamend Neuro, Inc. · Updated on 2026-04-20
20
Participants Needed
1
Research Sites
34 weeks
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
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.
CONDITIONS
Official 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...
- Age between 18 and 65 years with bipolar I disorder diagnosis
- In reasonably good physical health based on medical history, exams, ECG, vital signs, and lab tests
- Mental health stable with low mania and depression scores at screening and Day -1
- No recent worsening of depression
- No concerning suicidal ideation or behavior
- Stable mood stabilizing medication regimen for over 30 days or untreated but stable
- Able to understand, follow instructions, and willing to participate and comply with study procedures
- Any gender, race, or ethnicity
- Able to provide written informed consent
- Males must agree to use barrier contraception during the study
- Females must use acceptable contraception or be non-childbearing
- Able to communicate in English
- Body mass index 18.0 to 31.0 kg/m2 and weight at least 50 kg
- Normal ECG without significant abnormalities after rest
You will not qualify if you...
- Significant health issues that affect safety or study participation including hematological, renal, endocrine, pulmonary, cardiovascular, dermatologic, muscular, or allergic diseases
- History of drug hypersensitivity, asthma (except childhood asthma), or severe allergic conditions
- Any other disorder preventing study completion
- Severe acute, chronic, or historical medical or psychiatric condition or lab abnormality increasing risk or interfering with study
- History of seizure disorder or severe head trauma except single childhood febrile seizure
- Gastrointestinal diseases like chronic gastritis, ulcers, inflammatory bowel disease
- Acute or chronic liver disease
- Conditions affecting drug absorption or metabolism
- Frequent headaches or migraines
- Kidney disease with low filtration rate
- Uncontrolled heart rhythm issues or heart failure
- Active cancer requiring treatment (except certain skin cancers)
- Positive HIV, HBV, or HCV test except certain HCV cases
- Severe liver impairment
- Uncontrolled high blood pressure
- Fever or infections at screening or Day -1
- Psychiatric or neurological illnesses other than bipolar I disorder
- Use of certain antipsychotics or immunosuppressants
- Hyponatremia during lithium treatment
- Regular long-term use of medications or supplements not allowed by protocol
- Electroconvulsive therapy in last 6 months
- Unwillingness to avoid certain foods or substances
- Aspirin/nasal polyposis/asthma syndrome
- Breastfeeding or pregnancy
- History of adverse reaction to lithium, aspirin, or related substances
- Recent drug or alcohol abuse
- Excessive caffeine or xanthine intake, or unwillingness to avoid grapefruit and similar products
- Recent participation in other clinical trials with investigational drugs
- Untreated thyroid dysfunction
- MRI exclusion criteria including implants or intolerability
- History of suicide attempts or high suicidal ideation
- Suspected Brugada Syndrome
- CNS conditions that affect safety or study integrity such as untreated hypothyroidism or vitamin B12 deficiency
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
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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