RecruitingAlzheimer Disease
An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease
Eligible age
45–85 yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
Yes
See if you qualify for this study
Answer a few quick questions about your location and health. Takes about a minute.
About this study
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.
Sponsor: First Affiliated Hospital of Zhejiang University
You may qualify if…
- ✓ Mild Alzheimer's Disease (AD):
- ✓ 1. Age ≥ 45 years but ≤ 85 years;
- ✓ 2. Literacy level of elementary school and above (i.e., ≥3 years of education);
- ✓ 3. 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);
- ✓ 4. Clinical Dementia Rating Scale CDR-global = 1 point;
- ✓ 5. Aβ-PET scan suggesting extensive deposition of Aβ plaques in the brain.
- ✓ AD-derived mild cognitive impairment (aMCI) inclusion criteria (must meet all of the following conditions at the same time):
- ✓ 1. Age: 45 years or older but ≤85 years;
You may not qualify if…
- ✕ 1. 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;
- ✕ 2. 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.);
- ✕ 3. 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;
- ✕ 4. 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;
- ✕ 5. Oral anticoagulants (including warfarin and new oral anticoagulants, etc.);
- ✕ 6. Presence of contraindications to NMR such as metal implantation in the body;
- ✕ 7. Diseases such as aphasia, impaired consciousness, etc. that prevent cooperation in completing the cognitive examination;
- ✕ 8. Refusal to sign the informed consent.
Source: ClinicalTrials.gov · NCT07153848 · last updated 2026-07-31