Lecanemab treatment for early-onset familial Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Gang Wang — RenJi Hospital
• Study coordinator: Jinwen Xiao
• Email: jw_xiao78@163.com
• Phone: +86 13917310784

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Lecanemab Efficacy Monitoring with Gold Electrode ECL in Alzheimer’s

  This study tests how well lecanemab works in people with Alzheimer’s by using a new blood test based on mesoporous gold electrode ECL to track biomarkers.

  Recruiting Phase 4 The Fourth Affiliated Hospital of Zhejiang University School of Medicine · Yiwu, Zhejiang · NCT07688460

• Near-infrared light plus lecanemab for people with mild Alzheimer's

  This trial tests whether adding near-infrared light therapy to lecanemab helps people with mild Alzheimer's disease.

  Recruiting Early Phase 1 Xuanwu Hospital, Beijing · Beijing · NCT06992804

• Observational study of early Alzheimer's patients treated with Lecanemab

  This study is testing if the drug Lecanemab is safe and effective for people with early Alzheimer's disease and mild cognitive impairment.

  Recruiting Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT06741553

• Blood biomarker cohort for memory disorders in older adults

  This observational cohort will collect blood samples and brain imaging data from adults 50+ with memory disorders and a small group of healthy young adults to help find biomarkers.

  Recruiting Yonsei University · Seoul, Seodamun-gu · NCT07880275

• Tau changes after hip or knee replacement surgery

  Researchers will see if brain tau changes after hip or knee surgery and whether these changes relate to inflammation and thinking abilities.

  Recruiting Uppsala University Hospital · Uppsala · NCT07871487

• Low-Dose Whole-Brain Radiation Therapy With HeLaXON 1X in Mild Alzheimer's Dementia

  This study will test whether a low-dose brain radiation treatment using HeLaXON helps people with mild Alzheimer's dementia improve or stabilize thinking and daily function.

  Recruiting ReadyCure Inc. · Cheonan, Chungcheongnam-do · NCT07863011

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.