Lecanemab for Early Onset Familial Alzheimer's Disease

March 12, 2025 updated by: Wang Gang, RenJi Hospital

A Real World Study of Lecanemab Treatment in Participants with Early Onset Familial Alzheimer's Disease

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

114

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chang of CDR-SB score
Time Frame: baseline, 9 month, 18 month
CDR-SB, clinical dementia rating-sum of boxes
baseline, 9 month, 18 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of amyloid burden
Time Frame: baseline, 9 month, 18 month
AV45-PET
baseline, 9 month, 18 month
Change of ADAS-cog score
Time Frame: baseline, 9 month, 18 month
ADAS-cog, the Alzheimer's Disease Assessment Scale-Cognitive Subscale
baseline, 9 month, 18 month
Change of ADCS-ADL score
Time Frame: baseline, 9 month, 18 month
ADCS-ADL, the Alzheimer's Disease Cooperative Study - Activities of Daily Living Scale (ADCS-ADL)
baseline, 9 month, 18 month
Change of MoCA score
Time Frame: baseline, 9 month, 18 month
MoCA, the Montreal Cognitive Assessment
baseline, 9 month, 18 month
Change of BNT score
Time Frame: baseline, 9 month, 18 month
BNT, the Boston Naming Test
baseline, 9 month, 18 month
Change of TMT score
Time Frame: baseline, 9 month, 18 month
TMT, the trail making test
baseline, 9 month, 18 month
Change of HAMA and HAMD score
Time Frame: baseline, 9 month, 18 month
HAMA, Hamilton Anxiety Scale; HAMD, Hamilton Depression Scale
baseline, 9 month, 18 month
Change of biomarkers
Time Frame: baseline, 9 month, 18 month
p-tau181, p-tau217, Aβ40, Aβ42 , pEAβ3-42, GFAP, NFL, TRPC6 ( blood, urine, feces, gingival crevicular fluid, cerebrospinal fluid)
baseline, 9 month, 18 month
Positron emission tomography (PET)
Time Frame: baseline, 9 month, 18 month
Other PET including FDG-PET, Tau-PET, TSPO-PET, SV2A-PET, exendin-4 (GLP-1R)-PET, colinergic receptor probe (ASEM) PET
baseline, 9 month, 18 month
Change of structural MRI
Time Frame: baseline, 9 month, 18 month
3D T1-weighted, 3D T2-weighted and Diffusion Tensor Imaging (DTI)
baseline, 9 month, 18 month
Change of functional MRI
Time Frame: baseline, 9 month, 18 month
Blood oxygenation level dependent (BOLD) imaging
baseline, 9 month, 18 month
Change of magnetic susceptibility
Time Frame: baseline, 9 month, 18 month
Quantitative susceptibility mapping (QSM) imaging
baseline, 9 month, 18 month
Change of perfusion imaging
Time Frame: baseline, 9 month, 18 month
Arterial spin labeling (ASL) imaging
baseline, 9 month, 18 month
Whole Genome Sequencing
Time Frame: baseline
baseline
Change of speech information
Time Frame: baseline, 9 month, 18 month
Speech recording of Cookie-theft description task, using self-developed ASR speech analysis software (China software copyright number: 2016RS164680) for speech analysis
baseline, 9 month, 18 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

RenJi Hospital

Investigators

  • Principal Investigator: Gang Wang, RenJi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 13, 2025

Primary Completion (Estimated)

June 30, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

March 12, 2025

First Submitted That Met QC Criteria

March 12, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 12, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEOFAD-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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