Status:
RECRUITING
Lecanemab for Early Onset Familial Alzheimer's Disease
Lead Sponsor:
RenJi Hospital
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18-65 years
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 13 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 31 2027
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT06883019
Start Date
March 13 2025
End Date
August 31 2027
Last Update
March 19 2025
Active Locations (15)
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1
Xuanwu Hospital, Capital Medical University
Beijing, China, China
2
The Second Affiliated Hospital of Guangzhou Medical University
Guangdong, China, China
3
The Affiliated Hospital of Guizhou Medical University
Guizhou, China, China
4
Nanjing Brain Hospital
Jiangsu, China, China