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RecruitingNCT06883019Updated Mar 19, 2025

Lecanemab for Early Onset Familial Alzheimer's Disease

An observational study in Alzheimer Disease, sponsored by RenJi Hospital. Recruiting at 15 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-03-19.

Sponsored by RenJi Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
114
Ages
18 Years to 65 Years
Sex
All
01

Study summary

The goal of this observational study is to learn about the efficacy of Lecanemab treatment for early-onset familial Alzheimer's disease (AD) in patients under 65 years of age with a family history of AD. Participants will receive Lecanemab at a dosage of 10 mg/kg every two weeks for a total of 18 months and will undergo cognitive assessments, PET and MRI scans, blood/fluid tests and whole genome sequencing. The study will explore the effects of genetic and hereditary factors on the efficacy of Lecanemab treatment in early-onset familial AD patients.

02

Conditions studied

  • Alzheimer Disease

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Keywords

  • Alzheimer Disease
03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 114 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Renji Hospital, Shanghai Jiao Tong University School of Medicine Xuanwu Hospital, Capital Medical University Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Mental Health Center The First Affiliated Hospital, Zhejiang University School of Medicine The Second Affiliated Hospital of Guangzhou Medical University West China Hospital of Sichuan University Tianjin Medical University General Hospital Nantong First People's Hospital Huadong Hospital, Fudan University Jinhua Central Hospital Ningbo Second Hospital Nanjing Drum Tower Hospital Nanjing Brain Hospital The Affiliated Hospital of Guizhou Medical University

Inclusion criteria

  • Age at onset ≤ 65 years, with a minimum age of 18 years; no restriction on gender.
  • Diagnosis of Alzheimer's Disease (AD) and Mild Cognitive Impairment (MCI): Must meet the clinical diagnostic criteria for AD-related MCI and mild AD as defined by the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2011); confirmed Aβ positivity through Aβ-PET/CT, Aβ-PET/MRI, or cerebrospinal fluid testing.
  • MMSE ≥ 21 or MoCA ≥ 17 or CDR = 0.5
  • No significant signs found in the neurological examination
  • Participants must be capable of completing cognitive assessments and other tests.
  • Informed consent must be obtained from the participants and their legal guardians, with a dated signature, prior to any operations or tests related to the protocol, committing to comply with the research procedures and cooperate throughout the study process.

Exclusion criteria

Exclusion Criteria:

  • Cognitive decline caused by other reasons: cerebrovascular disease, central nervous system infections, Creutzfeldt-Jakob disease, Huntington's disease, Parkinson's disease, Lewy body dementia, traumatic dementia, other physical and chemical factors (drugs, alcohol, CO, etc.), significant systemic diseases (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial space-occupying lesions (subdural hematoma, brain tumor), endocrine system disorders (thyroid disease, parathyroid disease), and dementia caused by vitamin deficiencies or any other reasons.
  • Patients with other unstable diseases, or those who have had a stroke or transient ischemic attack, bleeding disorders, or seizures within the previous 12 months.
  • Patients with psychiatric disorders who meet DSM-IV criteria for schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium.
  • Patients with unstable or severe heart, lung, liver, kidney, hematological diseases; those with known malignancies or other serious prognoses.
  • Exclusion of cerebral amyloid angiopathy-related inflammation/β-amyloid-related cerebral vasculitis (CAAri/ABRA).
  • Presence of uncorrectable visual or auditory impairments that prevent completion of relevant assessments or scales.
  • Patients who cannot undergo MRI due to claustrophobia, pacemakers, defibrillators, or metal implants.
  • MRI findings showing more than four microhemorrhages (diameter \< 10 mm), evidence of surface iron deposition, vascular edema, diffuse white matter disease, multiple lacunar strokes, or any strokes involving major vascular regions. Presence of evidence of cerebral contusions, brain softening, cerebral aneurysms, or other vascular malformations, central nervous system (CNS) infections, as well as brain tumors other than meningiomas or arachnoid cysts.
  • Patients taking warfarin, vitamin K antagonists, or direct oral anticoagulants (dabigatran, rivaroxaban, edoxaban, apixaban, betrixaban) or heparin; patients receiving thrombolysis; patients with coagulation disorders.
  • Pregnant or lactating women.
  • Patients deemed unsuitable for use by clinicians apart from the exclusion criteria listed above.
  • Patients with severe allergies to lecanemab or any excipients of this product.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
114 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. Chang of CDR-SB score

    CDR-SB, clinical dementia rating-sum of boxes

    Time frame: baseline, 9 month, 18 month

Secondary outcomes

  1. Change of amyloid burden

    AV45-PET

    Time frame: baseline, 9 month, 18 month

  2. Change of ADAS-cog score

    ADAS-cog, the Alzheimer's Disease Assessment Scale-Cognitive Subscale

    Time frame: baseline, 9 month, 18 month

  3. Change of ADCS-ADL score

    ADCS-ADL, the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL)

    Time frame: baseline, 9 month, 18 month

  4. Change of MoCA score

    MoCA, the Montreal Cognitive Assessment

    Time frame: baseline, 9 month, 18 month

  5. Change of BNT score

    BNT, the Boston Naming Test

    Time frame: baseline, 9 month, 18 month

  6. Change of TMT score

    TMT, the trail making test

    Time frame: baseline, 9 month, 18 month

  7. Change of HAMA and HAMD score

    HAMA, Hamilton Anxiety Scale; HAMD, Hamilton Depression Scale

    Time frame: baseline, 9 month, 18 month

  8. Change of biomarkers

    p-tau181, p-tau217, Aβ40, Aβ42 , pEAβ3-42, GFAP, NFL, TRPC6 ( blood, urine, feces, gingival crevicular fluid, cerebrospinal fluid)

    Time frame: baseline, 9 month, 18 month

  9. Positron emission tomography (PET)

    Other PET including FDG-PET, Tau-PET, TSPO-PET, SV2A-PET, exendin-4 (GLP-1R)-PET, colinergic receptor probe (ASEM) PET

    Time frame: baseline, 9 month, 18 month

  10. Change of structural MRI

    3D T1-weighted, 3D T2-weighted and Diffusion Tensor Imaging (DTI)

    Time frame: baseline, 9 month, 18 month

  11. Change of functional MRI

    Blood oxygenation level dependent (BOLD) imaging

    Time frame: baseline, 9 month, 18 month

  12. Change of magnetic susceptibility

    Quantitative susceptibility mapping (QSM) imaging

    Time frame: baseline, 9 month, 18 month

  13. Change of perfusion imaging

    Arterial spin labeling (ASL) imaging

    Time frame: baseline, 9 month, 18 month

  14. Whole Genome Sequencing

    Time frame: baseline

  15. Change of speech information

    Speech recording of Cookie-theft description task, using self-developed ASR speech analysis software (China software copyright number: 2016RS164680) for speech analysis

    Time frame: baseline, 9 month, 18 month

07

Study locations

15 of 15 sites recruiting
  • Xuanwu Hospital, Capital Medical University
    Beijing, China
    Recruiting
  • The Second Affiliated Hospital of Guangzhou Medical University
    Guangdong, China
    Recruiting
  • The Affiliated Hospital of Guizhou Medical University
    Guizhou, China
    Recruiting
  • Nanjing Brain Hospital
    Jiangsu, China
    Recruiting
  • Nanjing Drum Tower Hospital
    Jiangsu, China
    Recruiting
  • Nantong First People's Hospital
    Jiangsu, China
    Recruiting
  • Huadong Hospital, Fudan University
    Shanghai, China
    Recruiting
  • Renji Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, China
    Recruiting
  • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
    Shanghai, China
    Recruiting
  • Shanghai Mental Health Center
    Shanghai, China
    Recruiting
  • West China Hospital of Sichuan University
    Sichuan, China
    Recruiting
  • Tianjin Medical University General Hospital
    Tianjin, China
    Recruiting
  • Jinhua Central Hospital
    Zhejiang, China
    Recruiting
  • Ningbo Second Hospital
    Zhejiang, China
    Recruiting
  • The First Affiliated Hospital, Zhejiang University School of Medicine
    Zhejiang, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 19, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06883019
Lead sponsor
RenJi Hospital
Responsible party
Wang Gang (Professor, RenJi Hospital) — Principal investigator
First posted
Mar 19, 2025
Start date
Mar 13, 2025 (estimated)
Primary completion
Jun 30, 2027 (estimated)
Completion
Aug 31, 2027 (estimated)
Last update
Mar 19, 2025

Study contacts

Jinwen Xiao
Contact
jw_xiao78@163.com
+86 13917310784
Gang Wang
principal investigator · RenJi Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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