An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease (NCT07153848) | Clinical Trial Compass
RecruitingNot Applicable
An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease
China400 participantsStarted 2024-07-01
Plain-language summary
The goal of this observational study is to valuate the sensitivity and specificity of different blood biomarkers for monitoring and assessing Aβ-PET-confirmed mitigation of amyloid pathology by lencanumab treatment in subjects treated with lencanumab.
Who can participate
Age range
45 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 45 years but ≤ 85 years;
. Literacy level of elementary school and above (i.e., ≥3 years of education);
. Fulfillment of the diagnostic criteria for probable AD in the NINCDS-ADRDA 2007 revision (or the diagnostic criteria for clinically probable AD in the National Institute on Aging and Alzheimer's Disease Association NIA-AA 2011 edition);
. Aβ-PET scan suggesting extensive deposition of Aβ plaques in the brain.
. Age: 45 years or older but ≤85 years;
. Literacy level elementary school and above (i.e., ≥3 years of education);
. Meeting Peterson's 2004 diagnostic criteria for MCI:
Exclusion criteria
. Those with a history of stroke and neurologic focal signs, head MRI scans excluding external infarct foci, brain softening foci and other occupying lesions, etc., as well as SWI sequences showing 5 or more microhemorrhagic foci, vascular malformations, etc;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is an observational study on lecanemab for early Alzheimer's disease, does this mean participants receive lecanemab as part of their regular care rather than being randomly assigned to it, and how would that affect my treatment decisions?
2The study is primarily measuring blood biomarkers — can you explain what those biomarkers are tracking, what the results might tell us about my condition, and whether I would personally receive that information?
3Since this study is listed as Phase NA and observational, what is already known about the safety and effectiveness of lecanemab, and is standard treatment or a different clinical approach something I should consider before joining an observational study like this?
4What does 'early Alzheimer's disease' mean in the context of this trial — would my current diagnosis and stage actually fit what researchers are looking for, and is that something worth exploring with the study team?
5How much time and how many visits would participating in this study realistically require, and would being in this observational trial affect my access to other treatments or future clinical trials?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of participants with blood biomarkers
Timeframe: Fresh plasma was collected at baseline, 3 months of follow-up, 6 months of follow-up, 12 months of follow-up, and 18 months of follow-up, respectively
Trial details
NCT IDNCT07153848
SponsorFirst Affiliated Hospital of Zhejiang University
. Presence of other neurological disorders that may cause brain dysfunction (e.g., schizophrenia, severe anxiety and depression, frontotemporal lobe dementia, Huntington's disease, brain tumors, Parkinson's disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, traumatic brain injury, and normal cranial pressure hydrocephalus, etc.);
. Presence of other systemic diseases that can cause cognitive impairment, such as hypothyroidism, folic acid and vitamin B12 deficiency, specific infections (e.g., syphilis, HIV), alcohol and drug abuse;
. Presence of a history of severe hepatic or renal insufficiency, severe pulmonary insufficiency, severe anemia, severe gastrointestinal disorders, severe cardiac arrhythmias, cardiac infarction within 6 months, and malignant tumors;
. Oral anticoagulants (including warfarin and new oral anticoagulants, etc.);
. Presence of contraindications to NMR such as metal implantation in the body;
. Diseases such as aphasia, impaired consciousness, etc. that prevent cooperation in completing the cognitive examination;