Alzheimer's Disease study: Trontinemab
Official title A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
ClinicalTrials.gov ID: NCT07717411
What this study is testing
What is Trontinemab?
Trontinemab is an investigational medicine being studied to see if it can help prevent Alzheimer's disease from getting worse in people who have early signs of the disease but no memory problems yet.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study aims to find out if trontinemab is safe and if it can help prevent healthy brain function from turning into memory problems or dementia.
- Who it's for
- The study is looking for people who have specific brain markers for Alzheimer's disease but do not currently have memory loss or trouble with daily tasks.
- What's involved
- Participants will receive the study drug and undergo regular medical tests to check their health and brain function.
- Time commitment
- The source text does not specify the total duration of the study or the exact number of visits required.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 80
You may be able to join if
- 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...
- Cognitively and functionally unimpaired as defined by the protocol
- Availability of a study partner as defined by the protocol
You likely can't join if
- Any evidence of a condition other than AD that may affect cognition, including, but not limited to, frontotemporal dementia, dementia with Lewy...
- 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
See the full eligibility 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
- 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...
- 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...
- 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...
- 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 treatment 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
The study team makes the final eligibility decision.
Where it is enrolling
- Irvine, California, United States
- Long Beach, California, United States
- Los Angeles, California, United States
- Oakland, California, United States
- Riverside, California, United States
- Santa Ana, California, United States
- Sherman Oaks, California, United States
- Maitland, Florida, United States
- Ocala, Florida, United States
- Orlando, Florida, United States
- Stuart, Florida, United States
- The Villages, Florida, United States
- Wellington, Florida, United States
- Winter Park, Florida, United States
- Columbus, Georgia, United States
- Honolulu, Hawaii, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Newton, Massachusetts, United States
- Watertown, Massachusetts, United States
+ 38 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Irvine, California, United States; Long Beach, California, United States; Los Angeles, California, United States; Oakland, California, United States; Riverside, California, United States; Santa Ana, California, United States and 52 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.