Watching Blood Markers During Lecanemab Treatment for Early Alzheimer's
Studies blood markers in people with early Alzheimer's treated with lecanemab.
Key facts
- Who runs it
- First Affiliated Hospital of Zhejiang University
- Where
- Hangzhou, ChinaSee the site
- Trial code
- Registry title
- An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease
- Status
- Recruiting
- People taking part
- 400 people, planned
- Started
- 1 Jul 2024
- Expected to end
- 31 Dec 2027
- Type of study
- Observational, 2 groups
- Record updated
- 31 July 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with mild Alzheimer's disease or mild memory and thinking problems linked to Alzheimer's, plus people with normal memory as a comparison group.
- Age
- 45 to 85 years for the patient groups; 55 to 85 years for the normal control group.
- Sex
- All sexes can join.
- Disease stage
- Mild Alzheimer's disease (CDR-global = 1) or mild cognitive impairment due to Alzheimer's (CDR-global = 0.5, MMSE 24 or more for those with junior high school or higher education). The Aβ-PET scan must show widespread Aβ plaques in the brain.
- Biomarker or test result
- Aβ-PET scan showing widespread Aβ plaque deposits in the brain (patient groups). The normal control group must show no significant Aβ deposits.
Main reasons for not taking part
- History of stroke or other brain diseases that can affect brain function
- Other illnesses that can cause memory problems, such as hypothyroidism, vitamin B12 deficiency or HIV
- Severe liver, kidney, lung, heart or stomach and bowel disease, or cancer
- Taking oral blood thinners (anticoagulants)
- Metal implants in the body that rule out MRI
The registry criteria, word for word
Show all 23 criteriaShow less
Who can take part
- Mild Alzheimer's Disease (AD):
- 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)
- Clinical Dementia Rating Scale CDR-global = 1 point
- 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):
- 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:; (i) Complaint of memory impairment that can be confirmed by an informed person; (ii) objective evidence of memory impairment (memory test scores 1-1.5 standard deviations below normal controls matched for age and literacy; e.g., Huashan Hospital's recommended cut-off values for those with elementary school literacy or above are as follows: long-delayed recall 50-59 years old ≤ 5, 60-69 years old ≤ 4, 70-79 years old ≤ 3, 80-89 years old ≤ 2, or re-recognition scores of 50-59 years old ≤ 20, 60-69 age ≤19 points, 70-79 years ≤18 points, 80-89 years ≤16 points); (iii) Overall cognitive functioning was largely preserved, with CDR-global = 0.5 points and MMSE: ≥24 points for those with junior high school or higher education used in this study; ④ Daily life ability remains normal (basically able to complete going out by transportation and shopping and counting, etc.); ⑤ Does not meet the International Classification of Diseases Diagnostic Manual, 10th edition dementia criteria (for research purposes) and the National Institute of Neurological and Speech-Language Disorders and Stroke, Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) likely diagnostic criteria for AD dementia; (vi) Aβ-PET scan suggested extensive deposition of Aβ plaques in the brain; Normal control Inclusion criteria (all of the following must be met simultaneously)
- Age ≥55 years but ≤85 years
- Elementary school 3 years of education and above
- MMSE: ≥26 points for those with junior high school or higher education
- CDR=0
- Activity of Daily Living Scale (ADL) score ≤ 20
- No significant deposition of Abeta in the brain as indicated by Aβ-PET scan
Who cannot take part
- 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
- 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
- Diseases such as aphasia, impaired consciousness, etc. that prevent cooperation in completing the cognitive examination
- Oral anticoagulants (including warfarin and new oral anticoagulants, etc.)
- Presence of contraindications to NMR such as metal implantation in the body
- Refusal to sign the informed consent
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 45 and 85 years old?
Where in China
- The First Affiliated Hospital of Zhejiang UniversityHangzhou, ChinaContact: Guoping Peng, PhDTaking people
About the trial
What the trial wants to find out
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.
The 2 groups in the trial
- donepezil treatment
In this cohort, a standardized treatment regimen of donepezil at a dose of 10 mg was employed.
- donepezil and lencanemab treatment
The group was treated with a combination regimen of lencanumab and donepezil. Lencanumab was administered at a dose of 10 mg/kg every two weeks, while donepezil was used at a dose of 10 mg per day.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- A Multicenter Cohort Study for Early Alzheimer's Disease in Zhejiang: an Observational Study on Lecanemab Treatment
- Plain-language title
- Watching Blood Markers During Lecanemab Treatment for Early Alzheimer'sGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT07153848, who can take part
- Record updated
- 31 July 2026