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

Exclusion criteria

• . The subject has a Rosen-modified Hachinski Ischemia Score \> 4 at the screening visit.
• . The subject has a known history of stroke or evidence from screening MRI that is clinically significant in the investigator's opinion.
• . 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.
• . 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.
• . The subject has a history of alcoholism or drug dependency/abuse within the last 5 years before screening.
• . The subject has been treated with any investigational product within 60 days or 5 half-lives (whichever is longer) prior to the screening visit.
• . The subject has been treated with anti-amyloid-beta or anti-tau protein monoclonal antibodies within one year prior to the screening visit.
• . The subject has been treated with an active vaccine targeting amyloid-beta or tau protein.