Lecanemab treatment in early Alzheimer's disease

A Multicenter Cohort Study for Early Alzheimer's Disease in Zhejiang: an Observational Study on Lecanemab Treatment

This project will test whether routine blood tests can track amyloid removal after lecanemab in people with early Alzheimer's who have positive amyloid PET scans.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 45 Years to 85 Years
• Sex: All
• Sponsor: First Affiliated Hospital of Zhejiang University (Academic / other)
• Drugs / interventions: lencanumab, lencanemab
• Locations: 2 sites (Hangzhou, Zhejiang and 1 other locations)
• Trial ID: NCT07153848 on ClinicalTrials.gov

What this trial studies

This prospective, real-world observational study followed patients with mild Alzheimer's disease or amnestic MCI who had positive Aβ-PET scans and were receiving lecanemab in Zhejiang Province. Plasma was collected at baseline and at 3, 6, 12, and 18 months, and amyloid PET imaging was performed at 12 and 18 months. Blinded central-lab assays of peripheral blood AD core markers were used to measure the sensitivity and specificity of blood biomarkers for detecting PET-confirmed amyloid changes after lecanemab. The cohort included patients on donepezil alone and those receiving lecanemab plus standard donepezil to develop a practical blood-based follow-up tool for clinical monitoring.

Who should consider this trial

Good fit: Adults aged 45–85 with at least elementary education who have mild Alzheimer's disease or amnestic MCI, a positive Aβ-PET scan, and who are receiving lecanemab (often alongside donepezil) would be ideal candidates.

Not a fit: Patients without PET-confirmed amyloid, those with moderate-to-severe Alzheimer's, people outside the 45–85 age range, or those not treated with lecanemab are unlikely to gain benefit from this monitoring approach.

Why it matters

Potential benefit: If successful, clinicians could use simple blood tests to monitor response to lecanemab instead of relying on costly or less accessible PET scans.

How similar studies have performed: Antibody trials including lecanemab have shown PET amyloid reductions and several studies report plasma biomarkers (for example, p-tau) track amyloid changes, so blood-based monitoring is promising though still being validated in real-world settings.

Eligibility criteria

Inclusion criteria (all of the following must be met simultaneously):

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;
2. Literacy level elementary school and above (i.e., ≥3 years of education);
3. 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).

1. Age ≥55 years but ≤85 years;
2. Elementary school 3 years of education and above;
3. MMSE: ≥26 points for those with junior high school or higher education;
4. CDR=0;
5. Activity of Daily Living Scale (ADL) score ≤ 20;
6. No significant deposition of Abeta in the brain as indicated by Aβ-PET scan.

Exclusion Criteria (excluded if any of the following conditions were met):

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.

Where this trial is running

Hangzhou, Zhejiang and 1 other locations

• The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
• The First Affiliated Hospital of Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Guoping Peng, PhD

Conditions Alzheimer Disease; lecanemab; biomarkers; blood