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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RenJi Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 12, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 12, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings