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

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 10 mIU/L) or vitamin B12 deficiency ( 4 or evidence of stroke within the past 5 years
• Systemic related exclusions:
• Active cancer (except squamous cell and basal skin cancers) requiring chemo- or radiation therapy
• Positive test results for HIV, HBV, and HCV (unless quantitative PCR negative for HCV) at Screening
• Uncontrolled hypertension with a sustained blood pressure >160/100 mmHg at Screening, check-in (Day -1), and prior to the first study drug administration
• 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