Observational study of early Alzheimer's patients treated with Lecanemab
A Study That Uses an Organized System to Prospectively Collect Uniform Data From a Defined Population
This study is testing if the drug Lecanemab is safe and effective for people with early Alzheimer's disease and mild cognitive impairment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | N/A to 85 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Drugs / interventions | Lecanemab |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06741553 on ClinicalTrials.gov |
What this trial studies
This study follows a cohort of patients diagnosed with early Alzheimer's disease and mild cognitive impairment who are treated with Lecanemab, a drug that targets amyloid-beta aggregation in the brain. The study aims to assess the safety and efficacy of Lecanemab, which has shown promise in previous clinical trials. Participants will undergo evaluations to confirm amyloid pathology and will be monitored for potential adverse effects related to the treatment. The goal is to gather data that could inform future treatment protocols for Alzheimer's disease.
Who should consider this trial
Good fit: Ideal candidates are individuals with early Alzheimer's disease or mild cognitive impairment, confirmed by specific cognitive assessments and amyloid pathology testing.
Not a fit: Patients with significant hemorrhagic conditions, those unable to tolerate MRI scans, or those on anticoagulants may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the effectiveness of Lecanemab in slowing cognitive decline in early Alzheimer's patients.
How similar studies have performed: Previous studies have shown success with Lecanemab in treating Alzheimer's, indicating a promising approach to managing the disease.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Mini-Mental State Examination (MMSE) score between 22 and 30, Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score between 0.5 and 1; * Confirmation of positive amyloid pathology by Amyloid-PET or cerebrospinal fluid Aβ testing; * Completion of APOE gene testing. * Willingness to use Lecanemab. Exclusion Criteria: * Unable to tolerate MRI scans; * MRI showing hemorrhagic manifestations, including \>4 microbleeds, surface iron deposition in any region, previous major hemorrhage, or potential brain lesions or vascular malformations; * Use of anticoagulants or antiplatelet drugs, presence of hemorrhagic diseases, or any other conditions that increase the risk of central nervous system bleeding; * With unstable physical conditions, unstable mental disorders, or those who are pregnant or breastfeeding.
Where this trial is running
Hangzhou, Zhejiang
- Affiliated Hospital, School of Medicine, Zhejiang University, China — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Study coordinator: Yanxing Chen, M.D.
- Email: chenyanxing@zju.edu.cn
- Phone: +86 188 6840 1257
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.