Study of Daratumumab in Patients With Mild to Moderate Alzheimer's Disease

Exclusion Criteria

• •1. The subject has a Rosen-modified Hachinski Ischemia Score \> 4 at the screening visit.
• •2. The subject has a known history of stroke or evidence from screening MRI that is clinically significant in the investigator's opinion.
• •3. The subject has evidence of a clinically relevant neurological disorder other than probable AD at the screening visit, including: vascular dementia, Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, progressive supranuclear palsy, corticobasal degeneration, amyotrophic lateral sclerosis, Huntington's disease, multiple sclerosis, mental retardation, hypoxic cerebral damage, or head trauma with loss of consciousness that led to persistent cognitive deficits.
• •4. The subject has evidence of a clinically relevant or unstable psychiatric disorder, based on DSM-5 criteria, including schizophrenia or other psychotic disorder, bipolar disorder, delirium, or major depression. (Major depression in remission is not exclusionary.) A score on the 15-item Geriatric Depression Scale (GDS) of 5 or more requires an assessment by an appropriate health care professional to evaluate for the presence of major depression. Subjects with a score of 5 or more who are not diagnosed with major depression following such an assessment may be included in the trial.
• •5. The subject has a history of alcoholism or drug dependency/abuse within the last 5 years before screening.
• •6. The subject has been treated with any investigational product within 60 days or 5 half-lives (whichever is longer) prior to the screening visit.
• •7. The subject has been treated with anti-amyloid-beta or anti-tau protein monoclonal antibodies within one year prior to the screening visit.
• •8. The subject has been treated with an active vaccine targeting amyloid-beta or tau protein.
• •9. The subject has received a live/live-attenuated bacterial or viral vaccine within 3 months prior to the screening visit.
• •10. The subject has been treated with immunosuppressive medications, such as azathioprine, cyclosporine, methotrexate, tacrolimus, or mycophenylate, within 2 months prior to the screening visit.
• •11. The subject has been treated with a course of corticosteroids longer than 5 days within 2 months prior to the screening visit.
• •12. The subject is taking or is anticipated to require treatment with estrogens.
• •13. The subject is taking or is anticipated to require treatment with an anticoagulant medication, including warfarin, dabigatran, rivaroxaban, apixaban, edoxaban, heparin, or enoxaparin.
• •14. The subject is taking or is anticipated to require treatment with aspirin at a dose higher than 325 mg daily.
• •15. The subject has a history of asthma or chronic obstructive pulmonary disease.
• •16. The subject has had a myocardial infarction, unstable angina, stroke, transient ischemic attack or required intervention for any of these conditions (e.g., coronary artery bypass graft, percutaneous coronary intervention via cardiac catheterization, thrombolytic therapy) within 6 months prior to the screening visit.
• •17. The subject has had an infection requiring medical intervention within 30 days prior to the screening visit.
• •18. The subject has serologic evidence of current or prior hepatitis B virus (HBV) infection based on hepatitis B surface antigen or hepatitis core antibody blood tests at the screening visit.
• •19. The subject has serologic evidence of hepatitis C virus (HCV) infection based on hepatitis C antibody blood test at the screening visit.
• •20. The subject has serologic evidence of human immunodeficiency virus (HIV) infection based on HIV antigen/antibody test at the screening visit.
• •21. The subject has a platelet count less than 50,000 per microliter (mL) at the screening visit.
• •22. The subject has a creatinine clearance less than 30 mL/minute at the screening visit.
• •23. The subject has a history or evidence of a malignancy (except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or localized prostate carcinoma) within the 2 years prior to the screening visit.
• •24. The subject has had any other unstable/uncontrolled medical illness within 12 weeks prior to the screening visit such that, in the judgment of the investigator, participation in the trial would pose a significant medical risk to the subject.
• •25. The subject has significant visual or auditory impairment, or limited English proficiency, that in the investigator's opinion would preclude collection of outcome measures.
• •26. The subject has any contraindication to or inability to tolerate brain MRIs (e.g., a pacemaker or any other implanted device or condition that would preclude proximity to a strong magnetic field).
• •27. The subject has any contraindication to or inability to tolerate a PET scan (includes current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the subject in any given year would exceed acceptable limits of annual and total dose).
• •28. The subject has a history of allergy to dexamethasone, diphenhydramine, acetaminophen, montelukast, or acyclovir.