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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

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data 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