NCT07604896 Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs
| NCT ID | NCT07604896 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | First Affiliated Hospital of Wenzhou Medical University |
| Condition | Alzheimer s Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 200 participants in total. It began in 2026-01-01 with a primary completion date of 2027-12-31.
⚠ 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
This research proposal outlines a multi-center, randomized, trial. Patients diagnosed with early-to-moderate Alzheimer's Disease will be recruited. Participants will be randomly assigned to receive either Lecanemab. The study will run over a period of 24 months, with evaluations conducted at baseline, 6 months, and 12 months, 18 months and 24 months. Data from multiple omics layers will be integrated to assess both the efficacy and safety of the treatment. The primary aim of this study is to assess the efficacy and safety of Lecanemab in patients with Alzheimer's Disease, leveraging multi-omics approaches. Specifically, the study will integrate data from OCT/OCTA imaging of the eye and MRI imaging of the brain, as well as cognitive measures such as ADAS-Cog, MoCA and CDR scores. Furthermore, the presence of ARIA-a significant safety concern in amyloid-targeting therapies-will be closely monitored. The study seeks to provide a more robust understanding of Lecanemab's impact on disease progression, cognition, and potential adverse effects, contributing to a more informed clinical application of this treatment in Alzheimer's care.
Eligibility Criteria
Inclusion Criteria: * Age: 50 to 90 years old. * No gender restrictions. * Patients with MCI and mild AD. * The MMSE score is ≥20, and the overall CDR score is 0.5 or 1 point. * Positive Amyloid protein confirmed by amyloid-PET or CSF. * There is a reliable caregiver accompanying the patient during the research visit and supervising the use of the study drug during the trial. * Agree to participate in the research and sign the informed consent form. Exclusion Criteria: * Patients with cognitive impairment caused by reasons other than AD. * There was a history of transient ischemic attack (TIA), stroke, cerebral hemorrhage or epileptic seizure within 12 months prior to screening. * A Hamilton Depression Scale score of more than 17 at the time of screening, or any suicidal behavior within 6 months before screening, during screening, or at baseline visits, as well as other psychiatric diagnoses or symptoms (such as hallucinations, anxiety disorders, or delusions) that interfere with the research process of the subjects. * Patients with hemorrhagic diseases or those receiving anticoagulant therapy, as well as any patients with malignant tumors, severe gastrointestinal, kidney, liver, respiratory, immune, endocrine and cardiovascular system diseases that affect this study. * There is a hypersensitivity reaction to lecanemumab or any other component in the injection solution or any monoclonal antibody treatment. * There are contraindications for MRI scans, including the installation of cardiac pacemakers/defibrillators and ferromagnetic metal implants (except for cranial and cardiac devices approved for safe use in MRI scans). * There is a known or suspected history of drug or alcohol abuse or dependence within two years prior to screening. * Subjects who participated in clinical studies involving any therapeutic monoclonal antibodies or novel compounds for the treatment of AD within 6 months prior to screening, unless it can be demonstrated that the subjects were in the placebo treatment group. * Surgical operations under general anesthesia are planned to be performed during the research period. * Women who have positive pregnancy test results, are breastfeeding or pregnant at the time of screening or baseline.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07604896 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 90 Years, studying Alzheimer s Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07604896 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07604896 currently recruiting?
Yes, NCT07604896 is actively recruiting participants. Contact the research team at wangzhen@wzhospital.cn for enrollment information.
Where is the NCT07604896 trial being conducted?
This trial is being conducted at Wenzhou, China.
Who is sponsoring the NCT07604896 clinical trial?
NCT07604896 is sponsored by First Affiliated Hospital of Wenzhou Medical University. The trial plans to enroll 200 participants.
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