RecruitingPhase 3

A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease

A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
55 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well trontinemab works and how safe it is. It is for people with test results showing signs of Alzheimer's disease, but no problems with thinking or daily tasks. These people are at risk of developing memory and thinking problems due to Alzheimer's.

This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or dementia due to AD.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Weigh 150 kg (about 331 pounds) or less.
  • Be willing and able to complete all parts of the study.
  • See and hear well enough to take thinking and memory tests. Glasses and hearing aids are allowed.
  • Have no problems with thinking or daily tasks, based on the study's rules.
  • Have a study partner who meets the study's rules.
  • Have a blood level of pTau217, a marker linked to Alzheimer's, that suggests a high chance of future symptoms.

Who can't join

  • Have mild thinking or memory problems, any dementia, or another condition that could affect thinking.
  • Have serious disease of the brain's blood vessels, a serious brain injury, or a significant growth inside the skull. A stroke with symptoms or a suspected mini-stroke in the past 12 months also rules out joining.
  • Have a history of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder; be at risk for suicide; or have had a substance use disorder in the past 12 months. Nicotine use is allowed.
  • Have an unstable or poorly controlled illness, uncontrolled high blood pressure, poor liver function, serious blood disease, abnormal thyroid function, or a history of cancer.
  • Have wet age-related macular degeneration, an eye disease; certain low vitamin B12 or folic acid levels; or current HIV, hepatitis B, or hepatitis C that has not been adequately treated.
  • Have received certain vaccines, antibody treatments, or other long-lasting drugs to prevent or delay thinking problems. Recent experimental treatments or immune protein treatments given by vein or under the skin also rule out joining.
  • Take or plan to take anticoagulants (blood thinners), or take cholinesterase inhibitors (certain memory drugs). Other medicine rules apply to recent antipsychotic use and stable doses of long-term pain, sleep, depression, or anxiety medicines.
  • Be in another treatment study or research that could affect thinking tests, or live in a skilled nursing or long-term care facility.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Body weight of 150 kg or less * Willingness and ability to complete all aspects of the study for the duration of the study * Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted) * Cognitively and functionally unimpaired as defined by the protocol * Availability of a study partner as defined by the protocol * A plasma pTau217 level consistent with a high likelihood of future clinical progression Exclusion Criteria: * 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 * Substance abuse disorder within 12 months prior to screening (nicotine use is allowed) * 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 * Current HIV, hepatitis B, or hepatitis C infection that has not been adequately treated in the opinion of the investigator * History of malignancy * 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 * Any other investigational treatment within 5 half-lives or 4 months prior to screening, whichever is longer * Intravenous (IV) or subcutaneous immunoglobulin therapy within 5 half-lives or 4 months prior to baseline whichever is longer * Anticoagulation medications at screening and there should be no plans to initiate any prior to or after randomization * 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 enrolled in an interventional study 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

Study sites (12)

CA

FL

NY

VA