NCT06883019Recruiting
Lecanemab for Early Onset Familial Alzheimer's Disease
A Real World Study of Lecanemab Treatment in Participants with Early Onset Familial Alzheimer's Disease
Source: ClinicalTrials.gov · Last updated 19 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 114 (estimated)
- First submitted
- 12 Mar 2025
- Start date
- 13 Mar 2025
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- RenJi Hospital
- Diseases
- Alzheimer disease
- NCT number
- NCT06883019
What you commit to
- Study type: Observational
- Planned participants: 114
- From 13 Mar 2025 to the primary completion date, 30 Jun 2027
- 15 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 who cannot undergo MRI due to claustrophobia, pacemakers, defibrillators, or metal implants.
- Patients taking warfarin, vitamin K antagonists, or direct oral anticoagulants (dabigatran, rivaroxaban, edoxaban, apixaban, betrixaban) or heparin; patients receiving thrombolysis; patients with coagulation disorders.
Other illness
- 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 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.
- 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 with severe allergies to lecanemab or any excipients of this product.
Other
- 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.
- Pregnant or lactating women.
- Patients deemed unsuitable for use by clinicians apart from the exclusion criteria listed above.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All
Sites (15)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Xuanwu Hospital, Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
| The Second Affiliated Hospital of Guangzhou Medical University Coordinator of this site? Confirm its status | Guangdong | China | Recruiting |
| The Affiliated Hospital of Guizhou Medical University Coordinator of this site? Confirm its status | Guizhou | China | Recruiting |
| Nanjing Drum Tower Hospital Coordinator of this site? Confirm its status | Jiangsu | China | Recruiting |
| Nanjing Brain Hospital Coordinator of this site? Confirm its status | Jiangsu | China | Recruiting |
| Nantong First People's Hospital Coordinator of this site? Confirm its status | Jiangsu | China | Recruiting |
| Huadong Hospital, Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Shanghai Mental Health Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| Renji Hospital Shanghai Jiao Tong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
| West China Hospital of Sichuan University Coordinator of this site? Confirm its status | Sichuan | China | Recruiting |
| Tianjin Medical University General Hospital Coordinator of this site? Confirm its status | Tianjin | China | Recruiting |
| Ningbo Second Hospital Coordinator of this site? Confirm its status | Zhejiang | China | Recruiting |
| Jinhua Central Hospital Coordinator of this site? Confirm its status | Zhejiang | China | Recruiting |
| The First Affiliated Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Zhejiang | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.