To Evaluate Safety, Tolerability and Pharmacological Effects of PU AD in Subjects With Mild AD Dementia

Inclusion Criteria: 1. Male or female aged 55 to 80 years old (inclusive) 2. Diagnosis of probable AD dementia based on National Institute on Aging and Alzheimer's Association (NIA/AA) AD Dementia diagnostic criteria 3. Mild AD as assessed by Mini Mental State Examination (MMSE) score between 18 to 26 at Screening Visit (inclusive) 4. Tau positive as evaluated by Tau PET using 18F-PI-2620 and assessment of tracer uptake in the medial temporal lobe and any cortical regions associated with Alzheimer's disease. 5. Geriatric Depression Scale score of ≤ 6 (on the staff administered short form) 6. Magnetic resonance imaging (MRI) or computerized tomography (CT) scan performed within the past 2 years that has confirmed no findings inconsistent with a diagnosis of AD 7. Subjects or his/her caregiver and/or legally authorized representative must have signed and dated an Institutional Review Board (IRB)/Independent Ethics Committee (IEC) approved written Informed Consent Form (ICF) 8. Subjects must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study 9. Must have one caregiver who, in the investigator's judgment, has frequent and sufficient contact with the subject (at least 10 hours/week) and is able to provide accurate information about the subject's cognitive and functional abilities; the caregiver must agree to, accompany the subject to clinic visits and/or be available by phone at designated times to provide information to the investigator and study staff about the subject, attend in person clinic visits that require partner input for scale completion, and must agree to monitor the subject's administration of any prescribed medications 10. Female must either be post menopausal (no menstrual period for \>1 year), or surgically sterilized (by hysterectomy, bilateral oophorectomy, or bilateral tubal ligation). 11. Males who are sexually active and whose partners are females of childbearing potential must agree to use condoms from screening through 90 days after administration of the last dose of IMP; their partners must be willing to use a medically acceptable method of contraception (a barrier method, intrauterine device, or hormonal contraception) from screening through 90 days after administration of the last dose of IMP 12. Must consent to Apolipoprotein E (ApoE) genotyping; the subject's ApoE status may be disclosed to him/her at the investigator's discretion - Exclusion Criteria: 1. Meets National Institute of Neurological Disorders and Stroke/Association Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN) criteria for vascular dementia 2. Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterological, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses of safety and pharmacologic effect in this study; or has a life expectancy of \< 2 years 3. Has had a history within the last 5 years of a serious infectious disease affecting the brain or head trauma resulting in protracted loss of consciousness 4. Has a history within the last 5 years of a primary or recurrent malignant disease with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal prostate specific antigen post treatment 5. Has a known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe post treatment hypersensitivity reactions 6. Has a "yes" answer to Columbia Suicide Severity Rating Scale (C-SSRS) suicidal ideation item 4 or 5, or any suicidal behavior assessment within 6 months of Screening, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening 7. Has received acetylcholinesterase inhibitor (AChEIs), memantine, and/or other AD therapy for less than 4 months or has less than 2 months of stable therapy on these treatments 8. Has not been stable on medications that affect the Central nervous system (CNS), for at least 4 weeks (including antidepressants, hypnotics, antipsychotics, etc.) except occasional use of benzodiazepine (definition of occasional use - not more than twice in a week or three times in a month during the past 3 months). 9. Has a history of chronic alcohol or drug abuse/dependence within the past 5 years 10. Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the investigator, might be a contributing cause to the subject's cognitive impairment (e.g., current history of substance abuse, uncontrolled vitamin B12 deficiency or abnormal thyroid function, stroke or other cerebrovascular condition, Parkinson's disease, Lewy body dementia, or frontotemporal dementia) 11. Transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening Visit 12. History of bleeding disorder or predisposing conditions, blood clotting, or clinically significant abnormal results on coagulation profile at Screening, as determined by the investigator 13. History of unstable angina, myocardial infarction, chronic heart failure (New York Heart Association Class III or IV), or clinically significant conduction abnormalities (e.g., unstable atrial fibrillation) within 1 year prior to Screening Visit 14. Clinically significant 12 lead Electrocardiogram (ECG) abnormalities, as determined by the investigator 15. Indication of impaired liver function as shown by an abnormal liver function profile at Screening (e.g., repeated values of Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≥ 2 × the upper limit of normal \[ULN\]) and/or indication of impaired renal function at Screening (e.g., repeated values of creatinine and blood urea nitrogen \[BUN\] ≥ 1.5 …

Reproduced word-for-word from the public registry record — the study team can answer questions about it.