Bipolar I DisorderPhase 1/2NCT07540338
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
A Phase 1/2 study testing AL001 and Lithium carbonate in people with Bipolar I Disorder, run by Alzamend Neuro, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar I Disorder
- What is being tested?
- AL001 and Lithium carbonate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2026to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with a primary psychiatric diagnosis of Bipolar I Disorder (BD1) between the age of ≥ 18 and ≤65 years who are in reasonably good physical health, as determined by the DSM-5-TR BD1 diagnostic criteria and the Investigator's review of medical and surgical history, physical examination (including neurological examination), 12-lead ECG, vital signs, and clinical laboratory tests.
- Assessment of subject's mental health status will be conducted to avoid enrolling subjects who are on the verge of a manic or depressive episode. Affective stability, defined by a Young Mania Rating Scale (YMRS) rating of ≤ 11 and a Hamilton Depression Rating Scale (HDRS-17) rating of < 16 at the Screening visit and on Day -1 (P1). Subsyndromal depression has not significantly worsened in the 4 weeks prior to randomization on Day -1 (P1) so as to avoid enrolling subjects who are on the verge of a full depressive episode. Assessment of subject's suicidal ideation and behavior (SI/B) using the Columbia-Suicide Severity Rating Scale (C-SSRS) will be conducted to avoid enrolling subjects with concerning results, defined as a history of a suicide attempt in the past two years, past year level 4 or higher suicidal ideation on the C-SSRS, or past month suicidal ideation of any kind. The "Lifetime/Recent" version will be used at screening and the "Since Last Visit" version will be used subsequently.
- Clinically acceptable, stably dosed mood stabilizing medication regimen, including treatment regimens with atypical antipsychotic drugs, for > 30 days prior to Screening visit, with no medication changes planned over the entire study period. See Section 6.3 for a list of medications not allowed for mood stabilization purposes. Exceptions to this may be made on a case-by-case basis following agreement by the Investigator and the Sponsor. Also, subjects with untreated BD1 can be enrolled if deemed adequately stable by the Investigator.
- Able to understand and follow instructions during the study as determined by the Investigator.
- Willing to follow study procedures.
- Willing and able to adhere to study restrictions and to be confined at the clinical research center per protocol requirements.
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- Any gender, race, or ethnicity.
- Able to understand and provide written informed consent.
- Males (non-vasectomized and vasectomized) must agree to use barrier contraception during the study until after Treatment Period 2 in-clinic follow-up visit on Day 23 (P2).
- Females must meet one of the following criteria:
- Is of childbearing potential and agrees to use an acceptable contraceptive method. Acceptable contraceptive methods include:
- 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).
- One of the following highly-effective contraceptive methods, used from at least 28 days prior to the Screening visit through to at least 30 days after the last dose of the study drug on Day 14 (P2).
- i. Systemic contraceptives (combined birth control pills, injectable/implant/insertable hormonal birth control products, or transdermal patch).
- ii. Intrauterine device (with or without hormones)
- iii. Male partner vasectomized at least 6 months prior to the Screening visit.
- One of the following double-barrier contraceptive methods, used from the Screening visit through to at least 30 days after the last dose of the second study drug on Day 14 (P2):
- i. Male condom used simultaneously with diaphragm plus spermicide.
- ii. Male condom used simultaneously with cervical cap plus spermicide.
- Or
- Is of non-childbearing potential, defined as surgically sterile (i.e., has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation), or is in a postmenopausal state (i.e., at least 1 year without menses prior to the Screening visit).
- Able to communicate in English, including speaking, reading, and writing.
- Body mass index (BMI) within 18.0 to 32.0 kg/m2, inclusive, and body weight of at least 50 kg at the time of Screening. Exceptions to this can be made on a case-by-case basis following agreement by the Investigator and the Sponsor.
- ECG recording, after at least 5 minutes of rest in a supine position, without clinically significant abnormalities as determined by the Investigator.
Who cannot join
- Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings (including prolonged QT interval), or clinical laboratory findings (as determined by the Investigator) that may affect the safety or successful participation of the subject. Specifically, evidence of clinically significant hematological, renal, endocrine, pulmonary, cardiovascular, dermatologic, muscular, or allergic disease or disorder (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) that may affect the safety or successful participation of the subject.
- Well defined diagnosis of drug sensitives with moderate to severe reactions (i.e., full body urticaria, reactions requiring hospitalization, etc.).
- Presence or history of any disorder other than the diagnosis under study that may prevent the successful completion of the study.
- Other severe acute, chronic, or historical medical or psychiatric condition or laboratory abnormality or social circumstance that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- History of seizure disorder and/or severe head trauma (other than a single childhood febrile seizure).
- Current uncontrolled gastrointestinal disease of moderate to severe nature such as chronic gastritis, peptic ulcers, inflammatory bowel disease, hemorrhagic gastritis, or duodenitis.
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- History or presence of acute or chronic liver disease as determined by the Investigator.
- Any surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the study treatments.
- Current treatment with migraine medications such as triptans, TCAs, or other serotonergic dominant medications.
- Kidney disease (eGFR < 60 mL/minute/1.73 m2).
- Uncontrolled tachy/brady arrhythmias, atrial fibrillation, or coronary heart failure.
- Systemic related exclusions:
- Active cancer (except squamous cell and basal skin cancers) requiring chemo- or radiation therapy.
- Positive test results for HIV, HBV, or HCV (unless quantitative PCR negative for HCV) at Screening.
- Severe hepatic impairment (Child-Pugh Class C).
- Uncontrolled hypertension with a sustained blood pressure > 160/100 mmHg at Screening, or at check-in on Day -1 (P1).
- Fever (body temperature > 101.4°F [38.5°C]), acute upper respiratory, or any other infections at Screening, or at check-in on Day -1 (P1).
- Secondary psychiatric or neurological illnesses other than-and not associated with-bipolar I disorder (e.g., bipolar II disorder exclusively, schizophrenia or other psychotic syndromes, ADHD, anxiety, PTSD, Parkinson's disease and related movement disorders, seizure disorder, and myasthenia gravis) that require treatment with medications included in section 6.3.
- Treatment with haloperidol, first generation antipsychotics, monoamine oxidase inhibitors, or neuromuscular blocking agents. Subjects who have ever received chronic immunosuppressant treatment (excluding topical or oral corticosteroids taken 1 year and 5 years before Screening, respectively).
- Current and during lithium treatment hyponatremia, defined as serum sodium laboratory value outside the standard reference range.
- The regular and long-term use of any medication, supplement, or OTC medication not approved by the Sponsor that can potentially interact with components of AL001 (outlined in section 6.3), within 14 days prior to the Screening visit or at least 6 times the respective elimination half-life, whichever is longer, through the completion of the study on Day 42 (P2). EXCEPTIONS to this include but are not limited to:
- Hormonal contraceptives for females of childbearing potential.
- Acetaminophen (up to 1000 mg TID) at the discretion of the Investigator.
- Low-Dose aspirin for cardio protection.
- Non-medicated ophthalmic products (for lubrication and comfort).
- Clinically acceptable, stably dosed mood stabilizing medication regimen for > 30 days prior to Screening visit, with no medication changes planned over the entire study period. See Section 6.3 for list of medications not allowed for mood stabilization purposes. Exceptions to this may be made on a case-by-case basis following agreement by the Investigator and the Sponsor.
- PRN medications needed for treatment of AE's during the study at the joint discretion of the Investigator and the Sponsor, reviewed on a case-by-case basis.
- Subjects treated with electroconvulsive therapy within 6 months prior to Screening visit.
- Unwilling to refrain from consumption of poppy seeds or quinine (tonic water) 48 hours prior to check-in on Day -1 (P1) until discharge from Period 2 treatment on Day 15 (P2).
- Aspirin/nasal polyposis/asthma syndrome.
- Female who is breastfeeding.
- Female who is pregnant according to the pregnancy test at Screening or on Day -1 (P1); female planning to become pregnant during the study.
- History of adverse or hypersensitivity reaction to lithium, aspirin, salicylate, L-proline, or any investigational or reference article excipient.
- Substance Use Disorder (SUD) / Alcohol Use Disorder (AUD):
- History of substance use (barbiturate, amphetamine, benzodiazepine, cocaine, opiates and cannabis) within the last 12 months or a positive urine drug screen at Screening or Day -1 (P1).
- Admitted alcohol use disorder or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements or positive ethanol (alcohol) test at Screening or Day -1 (P1).
- More than moderate current alcohol consumption. Subjects will be advised to consume no more than 2 units of alcohol per day and completely abstain from 72 hours prior to any study visit (1 unit is equal to approximately 10 g of pure alcohol, [250 mL] of beer [5%], 1 small glass [100 mL] of wine [12%], or 35 mL of spirits [35%]).
- Demonstrating excess xanthine consumption (e.g., ingests more than 5 cups of coffee or equivalent per day). Also, subject is not willing to refrain from xanthine products for 48 hours prior to check-in on Day -1 (P1) until discharge from Period 2 treatment on Day 15 (P2). The subject is not willing to refrain from grapefruit, pomelo, Seville orange products or juice within 14 days prior to check-in on Day -1 (P1) until discharge from Period 2 treatment on Day 15 (P2). Exceptions may be made on a case-by-case basis following agreement by the Principal Investigator and the Sponsor.
- Participation in a clinical trial and receipt of an investigational medication within 30 days or 5 half-lives (if known), whichever is greater, prior to the first dose of the current study drug.
- Clinically unstable thyroid dysfunction (required due to potential lithium drug-disease interaction).
- Screening MRI-related exclusion criteria: intracranial mass, evidence of other anatomical findings that might affect safety or causes of cognitive/behavioral impairment as assessed by a qualified neurologist. Subjects must not have any implantable medical device (e.g., aneurysm clip, vagus nerve stimulator, cardiac pacemaker) or be reliant on a non-removable medical device (e.g., insulin pump) unless that device is certified as MRI compatible. Known intolerability to MRI neuroimaging procedures.
- Subjects with any past apparent suicide attempt or suicidal behavior, within the past two years or a past year level 4 or higher SI/B (C-SSRS) or past month SI/B (C-SSRS) of any kind.
- Suspected of having or at risk for Brugada Syndrome.
- Central nervous system-related exclusions: Any medical condition that in the Investigator's judgement could affect subject safety and scientific integrity of the study, e.g., untreated hypothyroidism (TSH >10 mIU/L) or vitamin B12 deficiency (vitamin B12 <300 pg/mL) which may contribute to cognitive impairment, delirium, dementia and other encephalopathies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Study Coordinator, 617-724-9602, mghlimristudy@mgb.org
Ovidiu Andronesi, PhD, MD
About this study
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
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.
Read the detailed description
This study is researching the effects of a new type of crystallized lithium, AL001, on it's ability to reach the brain and have an effect in subjects with bipolar I disorder diagnosis. The investigators will be comparing this to a commonly used type of lithium, lithium carbonate. Investigators want to see if the AL001 can have the same or better effect when compared to lithium carbonate. Past research has shown a greater effect within the body with AL001 when compared to commonly used lithium.
This past research suggests that AL001 may be more effective, potentially allowing for lower doses and fewer side effects. If successful, this new form of lithium could offer a new and safe treatment option for psychiatric and neurological disorders.
This study involves two, 2-week long overnight stays at the main campus of Massachusetts General Hospital (MGH). During these stays, participants will receive lithium carbonate for one stay and the AL001 for the other. There are frequent blood draws and brain MRI scans during two periods of the study to look at how the AL001 is broken down in the body and to see how it reaches the brain. This study will compare AL001 to a study reference treatment of lithium carbonate. The majority of the blood draws and MRIs will occur over a 24 hour period during each 2-week long overnight stay at MGH.
- Conditions
- Bipolar I Disorder
- Being tested
- AL001, Lithium carbonate
- Keywords
- Neurology, Psychiatry, Pharmacokinetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AL001Drug
Also called lithium salicylate/L-proline cocrystal
Crystallized lithium
Lithium carbonateDrug
Lithium carbonate
| Study group | Role | What they receive |
|---|---|---|
| Sequence 1: AL001 then lithium carbonate | Other | 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. Receives: Drug: AL001; Drug: Lithium carbonate |
| Sequence 2: Lithium carbonate then AL001 | Other | 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. Receives: Drug: AL001; Drug: Lithium carbonate |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule.
Brain (and brain structures)-to-plasma ratios between AL001 and lithium carbonate for steady-state PK measures/ parameters.
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To evaluate differences in brain and/or brain structure lithium PK relative to plasma PK for AL001 capsule compared to a lithium carbonate capsule.
Area under the plasma and brain concentration versus time curve (AUC) will be measured.
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma AUCtau ss = Area under the plasma concentration versus time curve from time zero to the end of the 24-hour 3-dose interval at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state
To characterize AL001 lithium PK under the conditions of this study
Brain AUCtau ss = Area under the plasma concentration versus time curve from time zero to the end of the 24-hour 3- dose interval at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma Cmax ss = Maximum plasma concentration at steady-state.
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain Cmax ss = Maximum brain concentration at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma tmax ss = Time to reach the maximum plasma concentration at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain tmax ss = Time to reach the maximum brain concentration at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma Cmin ss = Minimum plasma concentration at steady-state (if at end-of-24 hour dosing interval: Ctrough
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain Cmin ss = Minimum brain concentration at steady-state (if at end-of-24 hour dosing interval: Ctrough)
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma tmin ss = Time to reach the minimum plasma concentration at steady-state over 24 hours
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain tmin ss = Time to reach the minimum brain concentration at steady-state over 24 hours
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain/Plasma AUCtau ss ratio = Ratio of brain/plasma areas under the plasma concentration versus time curve from time zero to the end of the 24-hour 3-dose interval at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain/Plasma Cmax ss ratio = Ratio of brain/plasma minimum concentrations from time zero to the end of the 24-hour 3-dose interval at steady-state.
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain/Plasma Cmin ss ratio = Ratio of brain/plasma minimum concentrations from time zero to the end of the 24-hour 3-dose interval at steady-state.
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma apparent oral clearance (CLoral) = Dose24 hours/Plasma AUCtau ss
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Average plasma concentration at steady-state (Css ave plasma) = Plasma 24 h AUCtau ss/24 hours
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Average brain concentration at steady-state (Css ave brain) = Brain 24 h AUCtau ss/24 hours
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma degree of fluctuation at steady-state (FIplasma ss) = Ratio of plasma (Cmax ss - Cmin ss) to Css ave plasma
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain degree of fluctuation at steady-state (FIbrain ss) = Ratio of brain 24 h (Cmax ss - Cmin ss) to Css ave brain
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Plasma swing 24 h = [(Cmax ss - Cmin ss)/ Cmin ss ]
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
Brain swing 24 h = [(Cmax ss - Cmin ss)/ Cmin ss ]
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 lithium PK under the conditions of this study
MRT oral doses (0-24h ss) = Mean Residence Time following oral doses at steady-state (0 to tau, end of 24-hour dosing interval)
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with adverse events and serious adverse events
Measured: From enrollment to end of follow-up period at Day 42(P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with abnormal vital signs
Measured: From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with abnormal values and change from baseline reading for each ECG parameter. Individual parameters including heart rate, PR, QT, QTcF, QRS, and RR intervals will be collected.
Measured: From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with abnormal findings on physical exam.
Measured: From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with abnormal values and changes from baseline for each Safety laboratory test (standard hematology, blood chemistry [clinical chemistry], urinalysis, and pregnancy test [for females of childbearing potential only).
Measured: From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with prevalence of plasma lithium concentrations above 1.2 mEq/L
Measured: From enrollment to Day 23 (P2)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Proportion of participants with prevalence of plasma salicylic acid concentrations above 30 mg/dL
Measured: From enrollment to Day 23 (P2)
Secondary outcomes (11)
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma AUCtau ss = Area under the plasma concentration versus time curve from time zero to the end of the 24-hour 3-dose interval at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma Cmax ss = Maximum plasma concentration at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma tmax ss = Time to reach the maximum plasma concentration at steady-state
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma Cmin ss = Minimum plasma concentration at steady-state (if at end-of-24 hour dosing interval: Ctrough)
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma tmin ss = Time to reach the minimum plasma concentration at steady-state over 24 hours
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma apparent oral clearance (CLoral) = Dose24 hours/Plasma AUCtau ss
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Average plasma concentration at steady-state (Css ave plasma) = Plasma 24 h AUCtau ss/24 hours
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma degree of fluctuation at steady-state (FIplasma ss) = Ratio of plasma (Cmax ss - Cmin ss) to Css ave plasma
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Plasma swing 24 h = [(Cmax ss - Cmin ss)/ Cmin ss ]
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
MRT oral doses (0-24h ss) = Mean Residence Time following oral doses at steady-state (0 to tau, end of 24-hour dosing interval)
Measured: From time zero to the end of the 24 hour 3-dose interval at steady state.
Exploring Brain Pharmacodynamics using Magnetic Resonance Spectroscopy
Magnetic resonance spectroscopy (MRS) techniques will be applied to explore brain metabolism, including possible metabolic similarities/differences between treatments
Measured: From Screening (Day 1) to Day 23 (P2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start11 May 2026
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar I DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alzamend Neuro, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540338
- Sponsor's protocol ID
- AL001-BD01
- Status last verified
- Jun 2026
- First submitted
- 17 Mar 2026
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07540338
- Acronym / sponsor ID
- AL001-BD01
- Conditions
- Bipolar I Disorder
- Keywords
- Neurology, Psychiatry, Pharmacokinetics
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Alzamend Neuro, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Study start
- 11 May 2026 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study is researching the effects of a new type of crystallized lithium, AL001, on it's ability to reach the brain and have an effect in subjects with bipolar I disorder diagnosis. The investigators will be comparing this to a commonly used type of lithium, lithium carbonate. Investigators want to see if the AL001 can have the same or better effect when compared to lithium carbonate. Past research has shown a greater effect within the body with AL001 when compared to commonly used lithium.
This past research suggests that AL001 may be more effective, potentially allowing for lower doses and fewer side effects. If successful, this new form of lithium could offer a new and safe treatment option for psychiatric and neurological disorders.
This study involves two, 2-week long overnight stays at the main campus of Massachusetts General Hospital (MGH). During these stays, participants will receive lithium carbonate for one stay and the AL001 for the other. There are frequent blood draws and brain MRI scans during two periods of the study to look at how the AL001 is broken down in the body and to see how it reaches the brain. This study will compare AL001 to a study reference treatment of lithium carbonate. The majority of the blood draws and MRIs will occur over a 24 hour period during each 2-week long overnight stay at MGH.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sequence 1: AL001 then lithium carbonate | Other | Drug: AL001, Drug: Lithium carbonateParticipants take 1050 mg of AL001 TID for 14 days then after a washout period, take 150 mg TID of lithium carbonate for 14 days. |
| Sequence 2: Lithium carbonate then AL001 | Other | Drug: AL001, Drug: Lithium carbonateParticipants take 150 mg of lithium carbonate TID for 14 days, then after a washout period, take 1050 mg of AL001 TID for 14 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (24 listed)
- Subjects with a primary psychiatric diagnosis of Bipolar I Disorder (BD1) between the age of ≥ 18 and ≤65 years who are in reasonably good physical health, as determined by the DSM-5-TR BD1 diagnostic criteria and the Investigator's review of medical and surgical history, physical examination (including neurological examination), 12-lead ECG, vital signs, and clinical laboratory tests.
- Assessment of subject's mental health status will be conducted to avoid enrolling subjects who are on the verge of a manic or depressive episode. Affective stability, defined by a Young Mania Rating Scale (YMRS) rating of ≤ 11 and a Hamilton Depression Rating Scale (HDRS-17) rating of < 16 at the Screening visit and on Day -1 (P1). Subsyndromal depression has not significantly worsened in the 4 weeks prior to randomization on Day -1 (P1) so as to avoid enrolling subjects who are on the verge of a full depressive episode. Assessment of subject's suicidal ideation and behavior (SI/B) using the Columbia-Suicide Severity Rating Scale (C-SSRS) will be conducted to avoid enrolling subjects with concerning results, defined as a history of a suicide attempt in the past two years, past year level 4 or higher suicidal ideation on the C-SSRS, or past month suicidal ideation of any kind. The "Lifetime/Recent" version will be used at screening and the "Since Last Visit" version will be used subsequently.
- Clinically acceptable, stably dosed mood stabilizing medication regimen, including treatment regimens with atypical antipsychotic drugs, for > 30 days prior to Screening visit, with no medication changes planned over the entire study period. See Section 6.3 for a list of medications not allowed for mood stabilization purposes. Exceptions to this may be made on a case-by-case basis following agreement by the Investigator and the Sponsor. Also, subjects with untreated BD1 can be enrolled if deemed adequately stable by the Investigator.
- Able to understand and follow instructions during the study as determined by the Investigator.
- Willing to follow study procedures.
Key exclusion criteria (44 listed)
- Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings (including prolonged QT interval), or clinical laboratory findings (as determined by the Investigator) that may affect the safety or successful participation of the subject. Specifically, evidence of clinically significant hematological, renal, endocrine, pulmonary, cardiovascular, dermatologic, muscular, or allergic disease or disorder (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) that may affect the safety or successful participation of the subject.
- Well defined diagnosis of drug sensitives with moderate to severe reactions (i.e., full body urticaria, reactions requiring hospitalization, etc.).
- Presence or history of any disorder other than the diagnosis under study that may prevent the successful completion of the study.
- Other severe acute, chronic, or historical medical or psychiatric condition or laboratory abnormality or social circumstance that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the subject inappropriate for entry into this study.
- History of seizure disorder and/or severe head trauma (other than a single childhood febrile seizure).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AL001Also: lithium salicylate/L-proline cocrystalCrystallized lithium | Drug | Sequence 1: AL001 then lithium carbonate, Sequence 2: Lithium carbonate then AL001 |
| Lithium carbonateLithium carbonate | Drug | Sequence 1: AL001 then lithium carbonate, Sequence 2: Lithium carbonate then AL001 |
Primary outcome
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.
Brain (and brain structures)-to-plasma ratios between AL001 and lithium carbonate for steady-state PK measures/ parameters.
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.
Area under the plasma and brain concentration versus time curve (AUC) will be measured.
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state
Plasma AUCtau ss = Area under the plasma concentration versus time curve from time zero to the end of the 24-hour 3-dose interval at steady-state
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain AUCtau ss = Area under the plasma concentration versus time curve from time zero to the end of the 24-hour 3- dose interval at steady-state
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma Cmax ss = Maximum plasma concentration at steady-state.
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain Cmax ss = Maximum brain concentration at steady-state
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma tmax ss = Time to reach the maximum plasma concentration at steady-state
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain tmax ss = Time to reach the maximum brain concentration at steady-state
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma Cmin ss = Minimum plasma concentration at steady-state (if at end-of-24 hour dosing interval: Ctrough
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain Cmin ss = Minimum brain concentration at steady-state (if at end-of-24 hour dosing interval: Ctrough)
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma tmin ss = Time to reach the minimum plasma concentration at steady-state over 24 hours
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain tmin ss = Time to reach the minimum brain concentration at steady-state over 24 hours
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain/Plasma AUCtau ss ratio = Ratio of brain/plasma areas under the plasma concentration versus time curve from time zero to the end of the 24-hour 3-dose interval at steady-state
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain/Plasma Cmax ss ratio = Ratio of brain/plasma minimum concentrations from time zero to the end of the 24-hour 3-dose interval at steady-state.
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain/Plasma Cmin ss ratio = Ratio of brain/plasma minimum concentrations from time zero to the end of the 24-hour 3-dose interval at steady-state.
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma apparent oral clearance (CLoral) = Dose24 hours/Plasma AUCtau ss
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Average plasma concentration at steady-state (Css ave plasma) = Plasma 24 h AUCtau ss/24 hours
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Average brain concentration at steady-state (Css ave brain) = Brain 24 h AUCtau ss/24 hours
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma degree of fluctuation at steady-state (FIplasma ss) = Ratio of plasma (Cmax ss - Cmin ss) to Css ave plasma
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain degree of fluctuation at steady-state (FIbrain ss) = Ratio of brain 24 h (Cmax ss - Cmin ss) to Css ave brain
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Plasma swing 24 h = [(Cmax ss - Cmin ss)/ Cmin ss ]
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Brain swing 24 h = [(Cmax ss - Cmin ss)/ Cmin ss ]
To characterize AL001 lithium PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
MRT oral doses (0-24h ss) = Mean Residence Time following oral doses at steady-state (0 to tau, end of 24-hour dosing interval)
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to end of follow-up period at Day 42(P2)
Proportion of participants with adverse events and serious adverse events
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to Day 23 (P2)
Proportion of participants with abnormal vital signs
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to Day 23 (P2)
Proportion of participants with abnormal values and change from baseline reading for each ECG parameter. Individual parameters including heart rate, PR, QT, QTcF, QRS, and RR intervals will be collected.
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to Day 23 (P2)
Proportion of participants with abnormal findings on physical exam.
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to Day 23 (P2)
Proportion of participants with abnormal values and changes from baseline for each Safety laboratory test (standard hematology, blood chemistry [clinical chemistry], urinalysis, and pregnancy test [for females of childbearing potential only).
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to Day 23 (P2)
Proportion of participants with prevalence of plasma lithium concentrations above 1.2 mEq/L
To evaluate the safety and tolerability of AL001 under multiple-dose, steady-state conditions in subjects with bipolar I disorder diagnosis under the conditions of this study.
Time frame: From enrollment to Day 23 (P2)
Proportion of participants with prevalence of plasma salicylic acid concentrations above 30 mg/dL
11 secondary outcomes
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
To characterize AL001 salicylic acid PK under the conditions of this study
Time frame: From time zero to the end of the 24 hour 3-dose interval at steady state.
Exploring Brain Pharmacodynamics using Magnetic Resonance Spectroscopy
Time frame: From Screening (Day 1) to Day 23 (P2)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing AL001 and Lithium carbonate in people with Bipolar I Disorder, run by Alzamend Neuro, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 24 inclusion and 44 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eve del Rio, MD, PhD ((908) 672-6388, eve@riopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 30 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2026.