Do you or a loved one suffer from the early stages of Alzheimer’s Disease?
This clinical research study is looking at the safety and effectiveness of an experimental treatment for people with early symptoms of Alzheimer’s Disease (AD).
The purpose of this study is to measure the difference in time to developing or worsening memory, thinking, or functional problems due to Alzheimer’s disease occurring in participants receiving study drug compared to placebo.
Participation could last up to 255 weeks including screening, a double-blind treatment period, and a double-blind observation period. In addition, eligible participants who receive placebo during the double-blind treatment period may choose to extend their study participation to receive open-label remternetug in an extension period.
Would you like to take part in clinical research?
As a volunteer in a research study, you will receive study-related medical care from the study doctor and regular follow-up of your condition to monitor the effectiveness of the care you will receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to other patients with Alzheimer’s disease, and whether it will be made widely available in Canada. Study volunteers are an important part of moving medical care forward.
You or your loved one may qualify to participate in this study if you/they:
- Have a phosphorylated tau (P-tau) result consistent with the presence of amyloid pathology.
- Have a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
- Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
- Have a Mini Mental Status Exam (MMSE) score consistent with no to minimal cognitive impairment.
- Have a Functional Activities Questionnaire (FAQ) score consistent with no to minimal functional impairment.
- Are currently receiving medications as symptomatic treatment for AD, dose has been stable for at least 30 days before screening.
You or your loved one may not qualify to participate in this study if you/they:
- Have dementia or significant other neurological disease that can affect cognition.
- Have current serious or unstable illnesses that in the investigator’s opinion, could interfere with the analyses of the study.
- Have a history of cancer that, in the investigator’s opinion, has a high risk of recurrence.
- Have a history of clinically significant multiple or severe drug allergies, or hypersensitivity reactions.
- Have a clinically important laboratory test result or other abnormality as determined by investigator that could be detrimental to the participant or could compromise the study.
- Have any contraindications for magnetic resonance imaging (MRI).
- Have a centrally read MRI demonstrating presence of ARIA-E, >4 cerebral microhemorrhages, any superficial siderosis, any macrohemorrhage, or severe white matter disease at screening.
- Have had prior treatment with a passive anti-amyloid immunotherapy within <5 half-lives prior to screening.
- Have received active immunization against Aβ in any other study
There are other eligibility requirements that the study doctor will review. Only the study doctor can finally determine whether they are eligible to participate in the study or not.
