Testing Trontinemab against a placebo for Alzheimer's disease

Exclusion

• −Current HIV, hepatitis B, or hepatitis C infection that has not been adequately treated in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →
• −Any evidence of a condition other than AD that may affect cognition, including, but not limited to, frontotemporal dementia, dementia with Lewy bodies, vascular dementia, Parkinson disease, corticobasal syndrome, Creutzfeldt-Jakob disease, progressive supranuclear palsy, frontotemporal lobar degeneration (other than frontotemporal dementia), Huntington disease, normal pressure hydrocephalus, seizure disorder, delirium, or hypoxia
• −Mild cognitive impairment (MCI; may be referred to as prodromal AD), or any form of dementia
• −History or presence of clinically significant cerebrovascular disease
• −History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma
• −History or presence of clinically significant intracranial mass
• −History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
• −History or presence of any stroke with clinical symptoms within the past 12 months, or documented history within the last 12 months of an acute event that is consistent, in the opinion of the PI, with a transient ischemic attack
• −At risk for suicide in the opinion of the investigator
• −Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments
• −Uncontrolled hypertension
• −Impaired hepatic function
• −History or presence of any clinically significant hematological diseases
• −Diagnosis of a wet age-related macular degeneration (AMD)
• −Abnormal thyroid function
• −Abnormally low serum levels of folic acid or vitamin B12 deficiency that are judged to be clinically significant and/or may impact cognition as per the investigator's judgment
• −History of malignancy
• −Any other investigational treatment within 5 half-lives or 4 months prior to screeningScreeningThe checks done before joining, to see whether a study fits.Read more →, whichever is longer
• −Intravenous (IV) or subcutaneous immunoglobulin therapy within 5 half-lives or 4 months prior to baselineBaselineYour starting measurements, taken before treatment begins.Read more → whichever is longer
• −Anticoagulation medications at screening and there should be no plans to initiate any prior to or after randomizationRandomisedWhich group you go into is decided by chance, not by you or your doctor.Read more →
• −Any treatment with cholinesterase inhibitors
• −Antipsychotic or neuroleptic medications within 3 months of screening, except as brief treatment for a non-psychiatric indication
• −Individuals with chronic use of opiates or opioids, benzodiazepines, barbiturates, or hypnotics, antidepressants or medication to treat anxiety should be on a stable dose for at least 8 weeks before baseline
• −Currently enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in an interventional studyInterventional studyA study where participants are given something to see what happens.Read more → including those requiring investigational medicinal product (IMP) or involving any type of medical research that may interfere with study cognitive assessments
• −Residence in a skilled nursing facility such as a convalescent home or long-term care facility
• −Any previous administration of active immunotherapy (vaccine) that is being evaluated to prevent or postpone cognitive decline
• −Any previous or current use of passive immunotherapy (immunoglobulin) or other long-acting biologic agent that is approved or under evaluation or has been evaluated to prevent or postpone cognitive decline
• −Substance abuse disorder within 12 months prior to screening (nicotine use is allowed)