Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs

Официальное название

Multicenter, Randomized, Controlled Study Evaluating the Efficacy and Safety of Lecanemab in Alzheimer's Disease Through Multi-omics Approachs

Обзор

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.

Вмешательства

• Препарат Lecanemab 10 mg/kg
  Lecanemab Injection Concentrate Solution (active ingredient at 100 mg/mL) is provided as a sterile aqueous solution containing 100 mg/mL of Lecanemab, 50 mmol/L citric acid, 350 mmol/L arginine/arginine hydrochloride, and 0.05% (w/v) polysorbate 80, with a pH of 5.0, and each vial is capable of being drawn into a volume of 5 mL. Lecanemab is to be administered via intravenous infusion over 60 minutes in saline solution. Lecanemab must be administered using an infusion system that includes a term
• Препарат Conventional anti-dementia treatment group
  Conventional anti-dementia treatment: Early-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment.

Первичные конечные точки

• Change in Aβ-PET centiloid values [Срок оценки: baseline, 12 month, 18 months]

Вторичные конечные точки (6)

• Change of retinal and cerbral imaging [Срок оценки: baseline, 6 month, 12 month]
• Change of MoCA score [Срок оценки: baseline, 6 month, 12 month, 18 months]
• Change of MMSE score [Срок оценки: baseline, 6 month, 12 month, 18 months]
• Change of CDR score [Срок оценки: baseline, 6 month, 12 month, 18 months]
• Change of structural MRI [Срок оценки: baseline, 6 month, 12 month, 18 month]
• Change of functional MRI [Срок оценки: baseline, 6 month, 12 month, 18 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• First Affiliated Hospital of Wenzhou Medical University — Wenzhou

Идентификаторы

NCT: NCT07604896 · KY2025-355

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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