Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AL001 · 3 trials · 5 indications
Brain (and brain structures)-to-plasma ratios between AL001 and lithium carbonate for steady-state PK measures/ parameters.
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
Proportion of participants with adverse events and serious adverse events
To evaluate the safety and tolerability of AL001 in healthy subjects and patients with adverse event(s), AD, descriptive statistics will be presented by treatment group for each cohort and overall, for the following: Proportion of participants with treatment-emergent adverse events (TEAEs) * Proportion of participants with serious AEs * Proportion of participants with TEAEs that lead to premature discontinuation * Proportion of participants with abnormal values for each safety laboratory test (change from baseline) * Proportion of participants with abnormal values for each Electrocardiogram (ECG) parameter (change from baseline in standard 12-lead ECG parameters) For all analyses, placebo-treated subjects from each Cohort were combined (pooled) to provide a composite placebo group for all comparisons. Adverse event profiles for all treated subjects were benign as were placebo-treated subjects. No further statistical analyses were therefore appropriate.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Multiple Ascending Doses of AL001 vs. Placebo - Cohort 1 | EXPERIMENTAL | Participants will be randomized to receive AL001. When adequate safety data are available, a review will be done for all participants to make a dose-escalation or dose and/or regimen modification decision. This will be repeated for each cohort. A total of 9 cohorts will receive 5 different dose levels of AL001 in multiple ascending doses under fasted conditions up to tolerability/safety limits. Cohort 1 will include 8 AD subjects. In this cohort, 6 active and 2 placebo AD subjects (as per randomization code) will receive the following treatment or placebo: • Cohort 1: 60% of 450 mg lithium carbonate equivalent of AL001 (1890 mg AL001 daily ×14 days, given as 3 × 210 mg AL001 capsules TID) |
| Multiple Ascending Doses of AL001 vs. Placebo - Cohorts 2a | EXPERIMENTAL | The data from the previous cohort must be deemed safe before the next sequential cohort may be enrolled and dosing initiated. Cohort 2a (8 healthy subjects - 4 non-elderly adults and 4 elderly adults). Per randomization, there will be 6 active and 2 placebo subjects in each cohort: • Cohort 2a: 100% 450 mg lithium carbonate equivalent of AL001 (3150 mg AL001 daily × 14 days, given as 5 × 210 mg AL001 capsules TID). |
| Multiple Ascending Doses of AL001 vs. Placebo - Cohort 3a | EXPERIMENTAL | The data from the previous cohort must be deemed safe before the next sequential cohort may be enrolled and dosing initiated. Cohort 3 will be sub-divided into 2 cohorts: Cohort 3a (8 healthy subjects - 4 non-elderly adults and 4 elderly adults) and Cohort 3b (8 AD subjects). Per randomization, there will be 6 active and 2 placebo subjects in each cohort: • Cohort 3a and 3b: 140% of 450 mg lithium carbonate equivalent of AL001 (4410 mg AL001 daily × 14 days, given as 7 × 210 mg AL001 capsules TID) |
| Multiple Ascending Doses of AL001 vs. Placebo - Cohort 4a | EXPERIMENTAL | The data from the previous cohort must be deemed safe before the next sequential cohort may be enrolled and dosing initiated. Cohort 4a (8 healthy subjects - 4 non-elderly adults and 4 elderly adults). Per randomization, there will be 6 active and 2 placebo subjects in each cohort: • Cohort 4a: 160% of 450 mg lithium carbonate equivalent of AL001 (5040 mg AL001 daily × 14 days, given as 8 × 210 mg AL001 capsules TID) |
| Multiple Ascending Doses of AL001 vs. Placebo - Cohort 5a | EXPERIMENTAL | The data from the previous cohort must be deemed safe before the next sequential cohort may be enrolled and dosing initiated. Cohort 5a (8 healthy subjects - 4 non-elderly adults and 4 elderly adults). Per randomization, there will be 6 active and 2 placebo subjects in each cohort: • Cohort 5a: 200% of 450 mg lithium carbonate equivalent of AL001 (6300 mg AL001 daily × 14 days - lithium dose equivalent to that used for bipolar/affective disorders, given as 10 × 210 mg AL001 capsules TID) |
| Multiple Ascending Doses of AL001 vs. Placebo - Cohorts 2b | EXPERIMENTAL | The data from the previous cohort must be deemed safe before the next sequential cohort may be enrolled and dosing initiated. Cohort 2b (8 AD subjects). Per randomization, there will be 6 active and 2 placebo subjects in each cohort: • Cohort 2b: 100% 450 mg lithium carbonate equivalent of AL001 (3150 mg AL001 daily × 14 days, given as 5 × 210 mg AL001 capsules TID). |
| Multiple Ascending Doses of AL001 vs. Placebo - Cohort 3b | EXPERIMENTAL | The data from the previous cohort must be deemed safe before the next sequential cohort may be enrolled and dosing initiated. Cohort 3b (8 AD subjects). Per randomization, there will be 6 active and 2 placebo subjects in each cohort: • Cohort 3b: 140% of 450 mg lithium carbonate equivalent of AL001 (4410 mg AL001 daily × 14 days, given as 7 × 210 mg AL001 capsules TID) |
| Multiple Ascending Doses of AL001 vs. Placebo - Cohort 4b | EXPERIMENTAL | The data from the previous cohort must be deemed safe before the next sequential cohort may be enrolled and dosing initiated. Cohort 4b (8 AD subjects). Per randomization, there will be 6 active and 2 placebo subjects in each cohort: • Cohort 4b: 160% of 450 mg lithium carbonate equivalent of AL001 (5040 mg AL001 daily × 14 days, given as 8 × 210 mg AL001 capsules TID) |
| Multiple Ascending Doses of AL001 vs. Placebo - Cohort 5b | EXPERIMENTAL | The data from the previous cohort must be deemed safe before the next sequential cohort may be enrolled and dosing initiated. Cohort 5b (8 AD subjects). Per randomization, there will be 6 active and 2 placebo subjects in each cohort: • Cohort 5b: 200% of 450 mg lithium carbonate equivalent of AL001 (6300 mg AL001 daily × 14 days - lithium dose equivalent to that used for bipolar/affective disorders, given as 10 × 210 mg AL001 capsules TID). |
| Name | Type | Description |
|---|---|---|
| AL001 | DRUG | Crystallized lithium |
| Lithium carbonate | DRUG | Lithium carbonate |
| Lithium Carbonate Capsule | DRUG | Lithium Carbonate |
| Placebo | OTHER | matching placebo formulation |
Inclusion Criteria: 1. 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, phy...
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AL001 is an investigational small molecule being developed for Alzheimer's Disease and Bipolar I Disorder. It is also being studied in pharmacokinetic trials involving healthy adults. The drug is currently in Phase 1 clinical development and has not been approved by the FDA.
AL001 is a lithium-based small molecule being developed as a potential treatment for Alzheimer's Disease and Bipolar I Disorder. It is designed to deliver lithium to the brain, and its mechanism of action is being investigated in clinical trials.
AL001 is being developed by Alzamend Neuro, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol ALZN. The company is conducting clinical trials of AL001 in the United States and Canada.
AL001 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The company has completed Phase 1 trials and is currently recruiting for an additional Phase 1 study in patients with Bipolar I Disorder.
AL001 has been studied in three clinical trials. NCT05363293 was a completed multiple ascending dose study in Alzheimer's patients and healthy adults. NCT06921590 was a completed pharmacokinetic study in healthy subjects. NCT07540338 is an ongoing Phase 1 trial in patients with Bipolar I Disorder.
AL001 is not the same as lithium carbonate, but it is being compared to it in clinical trials. Studies are investigating the brain and plasma pharmacokinetics of AL001 oral capsules compared to marketed immediate-release lithium carbonate capsules in healthy subjects and patients with Bipolar I Disorder.