An Observational Study on Lecanemab Treatment for Early Alzheimer's Disease

NCT07153848 | Recruiting

• 1 other identifier: lecanamab and biomarkers
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Alzheimer Disease

Keywords

lecanemab; Alzheimer Disease; biomarkers; blood

Outcome Measures

Primary Outcomes (1)

• Number of participants with blood biomarkers

  Blinded peripheral blood AD core marker testing including but not limited to Aβ40, Aβ42, total tau, p-tau181/217, NFL, GFAP

  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

Secondary Outcomes (3)

• Aβ-PET

  Amyloid PET scan at 12 months follow-up, 18 months follow-up

• Cognitive funtion - MMSE

  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

• Cognitive funtion - MoCA

  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

Study Arms (2)

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.

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Samples from a multicenter study cohort of early AD in Zhejiang Province (real-world study based on lencanumab treatment)

You may qualify if:

• 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.
• 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.
• 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;

You may not qualify if:

• 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;
• 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;
• Refusal to sign the informed consent.

Sponsors & Collaborators

• First Affiliated Hospital of Zhejiang University: lead

Study Sites (2)

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

The First Affiliated Hospital of Zhejiang University

Hangzhou, Zhejiang, 310003, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Guoping Peng, PhD

CONTACT

13588150613; pgpfc@163.com

Xiaoyan Liu, PhD

CONTACT

15824137598; liuxiaoyandongda@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2025
• First Posted: September 4, 2025
• Study Start: July 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: December 31, 2025
• Last Updated: September 4, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)