Lecanemab for Early Onset Familial Alzheimer's Disease

Launched by RENJI HOSPITAL · Mar 12, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a medication called Lecanemab to see how effective it is for treating early-onset familial Alzheimer's disease (AD) in people under 65 years old who have a family history of the disease. Participants will receive the treatment every two weeks for 18 months and will undergo various tests, including brain scans and cognitive assessments, to measure how well the medication is working and to understand how genetic factors might affect the treatment.

To be eligible for this trial, participants must be at least 18 years old and diagnosed with Alzheimer's disease or mild cognitive impairment. They should show specific signs of the disease through tests and must be able to complete the required assessments. However, individuals with cognitive decline due to other health issues, certain psychiatric disorders, or specific medical conditions may not be able to participate. If someone decides to join the study, they can expect regular visits for treatment and testing, which will help researchers gather important information about the impact of Lecanemab on early-onset familial Alzheimer's disease.

Gender

ALL

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.