NCT06883019 Lecanemab for Early Onset Familial Alzheimer's Disease
| NCT ID | NCT06883019 |
| Status | Recruiting |
| Phase | — |
| Sponsor | RenJi Hospital |
| Condition | Alzheimer Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 114 participants |
| Start Date | 2025-03-13 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 114 participants in total. It began in 2025-03-13 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Gang Wang
PRINCIPAL INVESTIGATOR
RenJi Hospital
Frequently Asked Questions
Who can join the NCT06883019 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06883019 currently recruiting?
Yes, NCT06883019 is actively recruiting participants. Contact the research team at jw_xiao78@163.com for enrollment information.
Where is the NCT06883019 trial being conducted?
This trial is being conducted at Beijing, China, Guangdong, China, Guizhou, China, Jiangsu, China and 11 additional locations.
Who is sponsoring the NCT06883019 clinical trial?
NCT06883019 is sponsored by RenJi Hospital. The principal investigator is Gang Wang at RenJi Hospital. The trial plans to enroll 114 participants.
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