Lecanemab for Early Onset Familial Alzheimer's Disease

NCT06883019 | Recruiting DMC

• 1 other identifier: LEOFAD-01
• Study Type: observational
• Target: 114
• Locations: 1 country
• Sites: 15

Brief 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.

Conditions

Alzheimer Disease

Keywords

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Chang of CDR-SB score

  CDR-SB, clinical dementia rating-sum of boxes

  baseline, 9 month, 18 month

Secondary Outcomes (15)

• Change of amyloid burden

  baseline, 9 month, 18 month

• Change of ADAS-cog score

  baseline, 9 month, 18 month

• Change of ADCS-ADL score

  baseline, 9 month, 18 month

• Change of MoCA score

  baseline, 9 month, 18 month

• Change of BNT score

  baseline, 9 month, 18 month

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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 with severe allergies to lecanemab or any excipients of this product.

Sponsors & Collaborators

• RenJi Hospital: lead

Study Sites (15)

Xuanwu Hospital, Capital Medical University

Beijing, China, China

RECRUITING

The Second Affiliated Hospital of Guangzhou Medical University

Guangdong, China, China

RECRUITING

The Affiliated Hospital of Guizhou Medical University

Guizhou, China, China

RECRUITING

Nanjing Brain Hospital

Jiangsu, China, China

RECRUITING

Nanjing Drum Tower Hospital

Jiangsu, China, China

RECRUITING

Nantong First People's Hospital

Jiangsu, China, China

RECRUITING

Huadong Hospital, Fudan University

Shanghai, China, China

RECRUITING

Renji Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, China

RECRUITING

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China, China

RECRUITING

Shanghai Mental Health Center

Shanghai, China, China

RECRUITING

West China Hospital of Sichuan University

Sichuan, China, China

RECRUITING

Tianjin Medical University General Hospital

Tianjin, China, China

RECRUITING

Jinhua Central Hospital

Zhejiang, China, China

RECRUITING

Ningbo Second Hospital

Zhejiang, China, China

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Zhejiang, China, China

RECRUITING

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

Study Officials

• Gang Wang

  RenJi Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jinwen Xiao

CONTACT

+86 13917310784; jw_xiao78@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 19, 2025
• Study Start: March 13, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 19, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)