Lecanemab treatment for early-onset familial Alzheimer's disease

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

This study tests if a drug called Lecanemab can help people under 65 with a family history of early-onset Alzheimer's disease feel better over 18 months.

Quick facts

• Study type: Observational
• Enrollment: 114 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: RenJi Hospital (Academic / other)
• Drugs / interventions: lecanemab
• Locations: 15 sites (Beijing, China and 14 other locations)
• Trial ID: NCT06883019 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the efficacy of Lecanemab in treating early-onset familial Alzheimer's disease in patients under 65 years old with a family history of the condition. Participants will receive Lecanemab at a dosage of 10 mg/kg every two weeks for 18 months, during which they will undergo cognitive assessments, PET and MRI scans, blood tests, and whole genome sequencing. The study will investigate how genetic and hereditary factors influence the treatment's effectiveness in this specific patient population.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 18 to 65 with a diagnosis of Alzheimer's disease or mild cognitive impairment and a family history of the condition.

Not a fit: Patients with cognitive decline due to other causes, such as cerebrovascular disease, will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into effective treatment options for early-onset familial Alzheimer's disease.

How similar studies have performed: While there have been studies on Lecanemab for Alzheimer's disease, this specific focus on early-onset familial Alzheimer's disease is relatively novel.

Eligibility criteria

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.

Where this trial is running

Beijing, China and 14 other locations

• 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)

Study contacts

• Principal investigator: Gang Wang — RenJi Hospital
• Study coordinator: Jinwen Xiao

Conditions Alzheimer Disease