Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:32 AM
Study NCT ID:
NCT07152418
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-03
First Post:
2025-08-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000612089', 'term': 'lecanemab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'targetDuration': '18 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-08-26', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Aβ-PET centiloid values', 'timeFrame': 'Baseline, 18 months', 'description': 'Statistical Comparison of Lecanemab versus Conventional Anti-Dementia Treatment Based on Aβ-PET Centiloid Scores'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in the CDR at 18 Months', 'timeFrame': 'Baseline, 18 months', 'description': 'Assessment of the Statistical Difference in CDR Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups'}, {'measure': 'Change from Baseline in the MMSE at 18 Months', 'timeFrame': 'Baseline, 18 months', 'description': 'Assessment of the Statistically Significant Difference in MMSE Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups'}, {'measure': 'Change from Baseline in the MoCA at 18 Months', 'timeFrame': 'Baseline, 18 months', 'description': 'Assessment of the Statistically Significant Difference in MoCA Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups'}, {'measure': 'Change from Baseline in the NPI at 18 Months', 'timeFrame': 'Baseline, 18 months', 'description': 'Assessment of the Statistically Significant Difference in NPI Scores Between Lecanemab and Conventional Anti-Dementia Treatment Groups'}, {'measure': 'Blood AD molecular pathology', 'timeFrame': 'Baseline, 6 months, 12 months, 18 months', 'description': 'Assess statistically significant difference in score between Lecanemab treatment group and Conventional anti-dementia treatment using Plasma AD biomarkers (Aβ42, Aβ42/Aβ40, T-tau, P-tau181, P-tau231, P-tau217, NFL levels)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alzheimer Disease', 'lecanemab', 'Tau PET', 'Aβ PET'], 'conditions': ['Alzheimer Disease (AD)', 'Alzheimer Dementia', 'Mild Cognitive Impairment (MCI)']}, 'descriptionModule': {'briefSummary': 'Preliminary clinical trial results indicate that Aβ-targeting monoclonal antibody drugs can delay disease progression more effectively. However, some patients still progress slowly to the moderate stage during treatment despite maintaining low Aβ/tau pathological protein loads. For such cases, patients and their families are fully informed about the potential lack of efficacy with continued treatment, and the decision is left to their discretion. Information regarding whether treatment is continued is documented and followed up to determine whether sustained benefits can be achieved. Previous further studies on lecanemab suggest that patients with low or absent tau pathology derive more significant clinical benefits, though large-sample validation remains lacking. This project will therefore enroll patients at clinical stages 3-4 (0.5 ≤ CDR ≤ 1) and monitor those progressing to moderate AD (CDR = 2) during monoclonal antibody therapy. Using tau pathology stratification, the study aims to identify which AD patients are most suitable for monoclonal antibody treatment and evaluate whether therapy continuation yields sustained benefits in patients progressing to moderate dementia, as well as whether patient selection should integrate both pathological (a-c stage) and clinical diagnoses.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study included early AD patients treated with Lecanemab and Conventional Anti-Dementia Treatment at the Second Affiliated Hospital of Zhejiang University School of Medicine.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Meet the diagnostic criteria for Mild Cognitive Impairment (MCI) due to Alzheimer's Disease or mild-to-moderate AD. \\[Clinical Scores: CDR Global Score = 0.5 (for MCI) or 1 (for mild AD), corresponding to clinical stages 3-4, with a positive PIB-PET scan confirming amyloid pathology\\]\n* Male or Female\n* Between 50 and 85 years old (inclusive)\n* Not currently participating in any other clinical trial or research study\n* Participants must provide informed consent for this trial prior to enrollment and must voluntarily sign a written informed consent form\n* Participants must be able to communicate effectively with the investigator and are expected to comply with the study requirements to completion\n\nExclusion Criteria:\n\n* Any contraindication to MRI\n* History of seizure within the past 6 months or refractory epilepsy.\n* Unstable or severe psychiatric illness within the past 6 months.\n* History of bleeding disorders, coagulopathy, or clinically significant coagulation abnormalities (e.g., platelet count \\<50,000/μL or INR \\>1.5).\n* Uncontrolled diabetes mellitus or hypertension.\n* History of unstable angina, myocardial infarction, advanced heart failure, or clinically significant conduction abnormalities within the past year.\n* Active cancer treatment (e.g., chemotherapy, biologics, or radiation therapy), except maintenance therapy for cancers in remission (e.g., anti-estrogen therapy for breast cancer).\n* Immunological disorders requiring ongoing immunosuppression, immunoglobulin therapy, monoclonal antibodies, or plasmapheresis.\n* Breastfeeding individuals or women of childbearing potential not using highly effective contraception.\n* History of severe allergic, anaphylactic reactions, or hypersensitivity to any inactive ingredients."}, 'identificationModule': {'nctId': 'NCT07152418', 'briefTitle': "Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research", 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': "A Study on the Therapeutic Efficacy of Monoclonal Antibody Drugs for Alzheimer's Disease Based on PET Research", 'orgStudyIdInfo': {'id': '2025-0466'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lecanemab treatment group', 'description': 'Lecanemab 10 mg/kg', 'interventionNames': ['Biological: Lecanemab 10 mg/kg']}, {'label': 'Conventional anti-dementia treatment', 'description': "Early-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment.", 'interventionNames': ['Drug: Conventional anti-dementia treatment group']}], 'interventions': [{'name': 'Lecanemab 10 mg/kg', 'type': 'BIOLOGICAL', 'description': '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 terminal 0.22 μM inline filter. The dosage of Lecanemab is 10 mg/kg.', 'armGroupLabels': ['Lecanemab treatment group']}, {'name': 'Conventional anti-dementia treatment group', 'type': 'DRUG', 'description': "Conventional anti-dementia treatment: Early-stage Alzheimer's disease (AD) patients routinely take cholinesterase inhibitors such as donepezil for treatment.", 'armGroupLabels': ['Conventional anti-dementia treatment']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Jiong Zhou, M.D.', 'role': 'CONTACT', 'email': 'ze-zj@zju.edu.cn', 'phone': '+86 139 5812 5492'}, {'name': 'Yaping Yan', 'role': 'CONTACT', 'email': 'yanyaping@zju.edu.cn', 'phone': '+86 151 6831 2676'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}