"MAD"

CompletedPhase 1 / PHASE2Results posted

Multiple Ascending Dose Safety, Tolerability, PK Study of AL001 in Alzheimer's Disease Patients & Healthy Adult Subjects

A Multiple-dose, Steady-state, Double-blind, Ascending Dose, Safety, Tolerability, Pharmacokinetic Study of AL001 in Patients With Mild to Moderate Alzheimer's Disease and Healthy Adult Subjects ("MAD Study")

Lead sponsor

Alzamend Neuro, Inc.

Asset

Latozinemab

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criteria

•mild-to-moderate AD•MMSE 16-26

Primary endpoint

•Serious AEs, TEAEs That Lead to Premature Discontinuation

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study IDAL001-ALZ02

NCT IDNCT05363293

Timeline

Milestones

Study start2022-05-04actual

Study first posted2022-05-05actual

Primary completion2023-04-14actual

Study completion2023-05-15actual

Last update posted2025-05-14actual

Results first posted2025-05-14actual

Assets

Drug assets

Latozinemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

(Alzheimer's Patients):

•Mild to moderate Alzheimer's disease (reasonably good physical health per Investigator's review of medical \& surgical history, physical examination incl. neurological examination, 12-lead ECG, vital signs, and clinical laboratory tests)

•Able to understand and provide written informed consent and able to understand and follow instructions during study as determined by Investigator

•Subject and caregiver (if accompanying subject on site) willing to follow study procedures, willing \& able to adhere to study restrictions and to be confined at the clinical research center for 16 days

•Fluent in English speaking, reading, and writing (for cognitive testing)

•Availability of medical history to provide information about the cognitive and functional level of the participant and of a qualified source such as the caregiver willing and able to provide information about the cognitive and functional level of the participant

•Males (non-vasectomized and vasectomized) must agree to use barrier contraception during the study until after Study Day 42

•Females must meet criteria if childbearing for contraception or be non-childbearing

•Clinical diagnosis of dementia (neurocognitive disorder) by a qualified clinician based on the DSM-V criteria

•Considered AD Stage 2, 3, or 4 based on the FDA classification

•Mini-Mental State Examination (MMSE) score between 16 and 26, inclusive, at Screening

•Negative result to COVID-19 test at Screening and admission (performed on Day -1)

Exclusion criteria

(Alzheimer's Patients):

•Clinically significant abnormalities (as determined by investigator based on medical history, physical examination, vital sign measurements, ECG findings, or clinical laboratory findings) that may affect subject safety or successful study participation

•Presence or history of any disorder 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 judgment of the Investigator, would make the subject inappropriate for entry into this study

•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 participant of the subject

•Any history or presence of gastrointestinal disease including chronic gastritis, hemorrhagic gastritis, peptic ulcers, duodenitis, diarrhea, or inflammatory bowel disease

•Any presence or history of acute or chronic liver diseases

•Any post-surgical or medical condition that may interfere with the absorption, distribution, metabolism, or excretion of the study treatment

•Any history of frequent headache or migraine

•Kidney disease (eGFR <60 mL/minute/1.73 m2)

•Uncontrolled tachy/brady arrhythmias, atrial fibrillation, or coronary heart failure

•Psychiatric or neurological illnesses (other than Alzheimer's disease), e.g., schizophrenia or other psychotic syndromes, Parkinson's disease and related movement disorders, myasthenia gravis, and seizure disorder/history of seizure disorder and/or severe head trauma (other than a single childhood febrile seizure)

•Presence of depression, except for mild depression with no acute episodes and stable condition, as determined by the Investigator

•History of untreated thyroid dysfunction that may be independently associated with cognitive impairment

•Central nervous system-related exclusions:

1. any medical condition that (per investigator's judgement) would affect subject safety and scientific integrity of the study, e.g., untreated hypothyroidism (TSH >10 mIU/L) or vitamin B12 deficiency (<300 pg/mL) which may contribute to cognitive impairment, delirium, non-AD dementia and other encephalopathies

2. Hachinski scale score >4 or evidence of stroke within the past 5 years

•Systemic related exclusions:

1. Active cancer (except squamous cell and basal skin cancers) requiring chemo- or radiation therapy

2. Positive test results for HIV, HBV, and HCV (unless quantitative PCR negative for HCV) at Screening

3. Uncontrolled hypertension with a sustained blood pressure >160/100 mmHg at Screening, check-in (Day -1), and prior to the first study drug administration

4. Fever (body temperature >101.4°F [38.5°C]), acute upper respiratory, or any other infections at Screening, check-in (Day -1), and prior to the first study drug administration

•Any history of drug hypersensitivity, asthma (with the exception of childhood asthma), urticaria or other severe allergic diathesis

•History of adverse - or hypersensitivity reaction to lithium, aspirin, salicylate, L-proline, or any test article excipient

•Female who is breastfeeding, pregnant according to the pregnancy test at Screening or prior to the first study drug administration, or planning to become pregnant during the study

•Magnetic resonance imaging (MRI)-related exclusion criteria (such as intracranial mass, evidence or other anatomical findings that might affect safety or causes of cognitive impairment as assessed by a qualified neurologist)

•History of drug abuse (barbiturate, amphetamine, benzodiazepine, cocaine, opiates and cannabis) within the last 12 months or a positive urine drug screen at Screening or Day -1

•Admitted alcohol abuse or history of alcohol use that may interfere with the subject's ability to comply with the protocol requirements or positive alcohol test at Screening or Day -1.

•More than moderate current alcohol consumption (subjects will be advised to consume no more than 2 units of alcohol/d and completely abstain from 72 hours prior to any visit.

•Treatment with haloperidol, antipsychotics, monoamine oxidase inhibitors, or neuromuscular blocking agents. An appropriate drug-free period will be required for washout, particularly for any especially long half-life drugs.

•Hyponatremia, defined as serum sodium laboratory value outside the standard reference range

•Suspected of having or at risk for Brugada Syndrome

•Prescribed or OTC use of a salicylate-containing product other than low-dose aspirin for cardioprotection (e.g., aspirin, bismuth sub-salicylate, salicylazosulfapyridine [sulfasalazine]) from 1 week before first dose to 1 week after last dosing; any other prescribed anticoagulant medication

•Consumption of poppy seeds or quinine (tonic water) 48 hours prior to Day 1

•Aspirin/nasal polyposis/asthma syndrome

•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.

Inclusion criteria (Healthy Subjects):

•Non-elderly (≥18 and <65 years) and elderly (≥65 and ≤80 years) male and/or female adult subjects of any gender, race or ethnicity, determined to be generally in good physical health

•Willingness to use contraceptive methods as appropriate

Exclusion criteria (Healthy Subjects)

•Clinically significant abnormalities detected by medical history, physical examination, vital sign measurements, ECG findings, or clinical laboratory findings or any historical or present condition/ treatment that may prevent successful or safe study completion, including substance abuse, kidney disease (estimated glomerular filtration rate [eGFR] <60 mL/minute/1.73 m2) or hyponatremia

•Use of any medication on a chronic basis except an oral contraceptive, with appropriate washout of prescription, OTC, vitamins and herbal supplements

•Female pregnant or planning to be pregnant, or breastfeeding

Endpoints (6)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK

Other (unclassified)

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

Number of Participants With Serious AEs, TEAEs That Lead to Premature Discontinuation, Abnormal Laboratory Test Results, Abnormal ECG Readings.

Time frame:42 days with a 14-day treatment period

change from baseline, event

Primary/registry result

Number of Participants With Serious AEs, TEAEs That Lead to Premature Discontinuation, Abnormal Laboratory Test Results, Abnormal ECG Readings.

Time frame:42 days with a 14-day treatment period

change from baseline, event

Posted result

Group	Value (count_of_participants), Participants	Reported bounds
Multiple Ascending Doses of AL001 vs. Placebo - Cohort 1Serious AEsn=6 Participants	0	-
TEAEs that lead to premature discontinuationn=6 Participants	0	-
Abnormal values for safety laboratory tests (change from baseline)n=6 Participants	0	-
abnormal ECG parameters (change from baseline)n=6 Participants	0	-
No Adverse Events observedn=6 Participants	6	-
Multiple Ascending Doses of AL001 vs. Placebo - Cohort 2aSerious AEsn=6 Participants	0	-
TEAEs that lead to premature discontinuationn=6 Participants	0	-
Abnormal values for safety laboratory tests (change from baseline)n=6 Participants	0	-
abnormal ECG parameters (change from baseline)n=6 Participants	0	-
No Adverse Events observedn=6 Participants	6	-
Multiple Ascending Doses of AL001 vs. Placebo - Cohort 2bSerious AEsn=6 Participants	0	-
TEAEs that lead to premature discontinuationn=6 Participants	0	-
Abnormal values for safety laboratory tests (change from baseline)n=6 Participants	0	-
abnormal ECG parameters (change from baseline)n=6 Participants	0	-
No Adverse Events observedn=6 Participants	6	-
Multiple Ascending Doses of AL001 vs. Placebo - Cohort 3aSerious AEsn=6 Participants	0	-
TEAEs that lead to premature discontinuationn=6 Participants	0	-
Abnormal values for safety laboratory tests (change from baseline)n=6 Participants	1	-
abnormal ECG parameters (change from baseline)n=6 Participants	0	-
No Adverse Events observedn=6 Participants	5	-
Multiple Ascending Doses of AL001 vs. Placebo - Cohort 3bSerious AEsn=6 Participants	0	-
TEAEs that lead to premature discontinuationn=6 Participants	0	-
Abnormal values for safety laboratory tests (change from baseline)n=6 Participants	0	-
abnormal ECG parameters (change from baseline)n=6 Participants	0	-
No Adverse Events observedn=6 Participants	6	-
Multiple Ascending Doses of AL001 vs. Placebo - Cohort 4aSerious AEsn=6 Participants	0	-
TEAEs that lead to premature discontinuationn=6 Participants	0	-
Abnormal values for safety laboratory tests (change from baseline)n=6 Participants	1	-
abnormal ECG parameters (change from baseline)n=6 Participants	0	-
No Adverse Events observedn=6 Participants	5	-
Multiple Ascending Doses of AL001 vs. Placebo - Cohort 4bSerious AEsn=6 Participants	0	-
TEAEs that lead to premature discontinuationn=6 Participants	0	-
Abnormal values for safety laboratory tests (change from baseline)n=6 Participants	0	-
abnormal ECG parameters (change from baseline)n=6 Participants	0	-
No Adverse Events observedn=6 Participants	6	-
Multiple Ascending Doses of AL001 vs. Placebo - Cohort 5aSerious AEsn=6 Participants	0	-
TEAEs that lead to premature discontinuationn=6 Participants	0	-
Abnormal values for safety laboratory tests (change from baseline)n=6 Participants	0	-
abnormal ECG parameters (change from baseline)n=6 Participants	0	-
No Adverse Events observedn=6 Participants	6	-
Multiple Ascending Doses of AL001 vs. Placebo - Cohort 5bSerious AEsn=0 Participants	0	-
Multiple Ascending Doses of AL001 - Pooled Placebo GroupSerious AEsn=16 Participants	0	-
TEAEs that lead to premature discontinuationn=16 Participants	0	-
Abnormal values for safety laboratory tests (change from baseline)n=16 Participants	0	-
abnormal ECG parameters (change from baseline)n=16 Participants	0	-
No Adverse Events observedn=16 Participants	16	-

Secondary/protocol endpoint

Maximum Tolerated Dose of AL001 (Salicylate Component) in All AL001-treated Subjects

Time frame:42 days with a 14-day treatment period

threshold achievement, event

Secondary/registry result

Maximum Tolerated Dose of AL001 (Salicylate Component) in All AL001-treated Subjects

Time frame:42 days with a 14-day treatment period

threshold achievement, event

Posted result

Group	Value (number), Proportion of Subjects	Reported bounds
Multiple Ascending Doses of AL001 in AD Subjects - Cohort 1n=6 Participants	0	-
Multiple Ascending Doses of AL001 in Healthy Subjects - Cohort 2an=6 Participants	0	-
Multiple Ascending Doses of AL001 in AD Subjects - Cohort 2bn=6 Participants	0	-
Multiple Ascending Doses of AL001 in Healthy Subjects - Cohort 3an=6 Participants	0	-
Multiple Ascending Doses of AL001 in AD Subjects - Cohort 3bn=6 Participants	0	-
Multiple Ascending Doses of AL001 in Healthy Subjects - Cohort 4an=6 Participants	0	-
Multiple Ascending Doses of AL001 in AD Subjects - Cohort 4bn=6 Participants	0	-
Multiple Ascending Doses of AL001 in Healthy Subjects - Cohort 5an=6 Participants	0.167	-
Multiple Ascending Doses of AL001 - Pooled Placebo Groupn=16 Participants	0	-

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Maximum Tolerated Dose of AL001 (Lithium Component) in All Subjects Treated With AL001

Time frame:42 days with a 14-day treatment period

threshold achievement, improvement

Secondary/registry result/low confidence

Maximum Tolerated Dose of AL001 (Lithium Component) in All Subjects Treated With AL001

Time frame:42 days with a 14-day treatment period

threshold achievement, improvement

Posted result

Group	Value (number), Proportion of Subjects	Reported bounds
Multiple Ascending Doses of AL001 in AD Subjects - Cohort 1n=6 Participants	0	-
Multiple Ascending Doses of AL001 in Healthy Subjects - Cohort 2an=6 Participants	0	-
Multiple Ascending Doses of AL001 in AD Subjects - Cohort 2bn=6 Participants	0	-
Multiple Ascending Doses of AL001 in Healthy Subjects - Cohort 3an=6 Participants	0	-
Multiple Ascending Doses of AL001 in AD Subjects - Cohort 3bn=6 Participants	0	-
Multiple Ascending Doses of AL001 in Healthy Subjects - Cohort 4an=6 Participants	0	-
Multiple Ascending Doses of AL001 in AD Subjects - Cohort 4bn=6 Participants	0	-
Multiple Ascending Doses of AL001 in Healthy Subjects - Cohort 5an=6 Participants	0.167	-
Multiple Ascending Doses of AL001 - Pooled Placebo Groupn=16 Participants	0	-

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.