Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-28 @ 12:11 AM
Study NCT ID:
NCT06058234
Status:
RECRUITING
Last Update Posted:
2023-09-28
First Post:
2023-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Medicare Anti-Aβ mAb Coverage With Evidence Development (CED) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8680}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2029-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2023-09-21', 'lastUpdatePostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in cognition', 'timeFrame': '24 months', 'description': 'Cognition measured by the Montreal Cognitive Assessment (MoCA©) (score ranges from 0 to 30; higher scores are generally better).'}, {'measure': 'Change in cognition', 'timeFrame': '24 months', 'description': 'Cognition as measured by global Clinical Dementia Rating (CDR) (each of six domains ranges from 0 to 3; lower scores are generally better).'}, {'measure': 'Change in function', 'timeFrame': '24 months', 'description': 'Function as measured by global Clinical Dementia Rating (CDR) (each of six domains ranges from 0 to 3; lower scores are generally better).'}, {'measure': 'Change in function', 'timeFrame': '24 months', 'description': 'Function as measured by the Functional Activities Questionnaire (FAQ) (scores range from 0 to 30; lower scores are generally better).'}, {'measure': 'Adverse Events (Harms)', 'timeFrame': '24 months', 'description': 'Incidence of adverse events such as amyloid related imaging abnormalities (ARIA), stroke, infections.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Mild Alzheimer's Disease", "Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.cms.gov/medicare-coverage-database/view/ncacal-decision-memo.aspx?proposed=N&ncaid=305', 'label': 'medicare National Coverage Determination'}, {'url': 'https://qualitynet.cms.gov/alzheimers-ced-registry', 'label': "Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease CED Study Registry"}, {'url': 'https://www.cms.gov/files/document/ced-study-description.pdf', 'label': 'Study Description'}]}, 'descriptionModule': {'briefSummary': "The Anti-Aβ mAb CED Study is a prospective, longitudinal coverage with evidence development (CED) study using clinical data, patient assessments, and administrative claims data of the Medicare population, conducted in accordance to the National Coverage Determination (NCD) on Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease (AD).", 'detailedDescription': "The Anti-Aβ mAb CED Study is conducted in accordance with the coverage criteria specified in the NCD for patients who have a clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD dementia. The complete NCD decision memorandum is available on our website (https://www.cms.gov/medicare-coverage-database/view/ncacal-decisionmemo.aspx?proposed=N\\&ncaid=305).\n\nStudy Overview:\n\n1. Clinicians will conduct a neurocognitive evaluation to determine patient eligibility by confirming a clinical diagnosis of MCI due to AD or mild AD dementia, and the presence of amyloid using biomarker testing including imaging (amyloid PET), cerebral spinal fluid (CSF) studies, and/or blood tests.\n2. For all Medicare beneficiaries receiving anti-Aβ mAb treatment for MCI due to AD or mild AD dementia, the prescribing clinician will assess the patient's baseline clinical status by cognition and function assessments using validated tools appropriate for use in the MCI with AD and mild AD dementia populations and submit these data to the registry via the dedicated CMS CED submission portal every six months for up to 24 months (five total assessments).\n3. In addition to performing the required cognition and function assessments, prescribing clinicians will need to report on the patient's use of anti-platelet and/or anti-coagulation therapy and whether the patient has developed new amyloid related imaging abnormalities (ARIA) since the last assessment data submission."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Medicare patients with a clinical diagnosis of mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia, both with confirmed presence of amyloid beta pathology consistent with AD.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Medicare patients with a clinical diagnosis of mild cognitive impairment due to Alzheimer's disease (AD) or mild AD dementia, both with confirmed presence of amyloid beta pathology consistent with AD.\n\nExclusion Criteria:\n\n* none"}, 'identificationModule': {'nctId': 'NCT06058234', 'briefTitle': 'Medicare Anti-Aβ mAb Coverage With Evidence Development (CED) Study', 'organization': {'class': 'FED', 'fullName': 'Centers for Medicare and Medicaid Services/ Coverage and Analysis Group'}, 'officialTitle': "Prospective Study on Anti-Amyloid-β Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease Coverage of Evidence Development (The Anti-Aβ mAb CED Study)", 'orgStudyIdInfo': {'id': '99999999'}}, 'armsInterventionsModule': {'interventions': [{'name': "Monoclonal Antibodies Directed Against Amyloid for the Treatment of Alzheimer's Disease", 'type': 'DRUG', 'description': 'FDA approved monoclonal antibodies directed against amyloid for the treatment of AD'}]}, 'contactsLocationsModule': {'locations': [{'zip': '21244', 'city': 'Baltimore', 'state': 'Maryland', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'CMS CAG', 'role': 'CONTACT', 'email': 'CMS_caginquiries@cms.hhs.gov', 'phone': '410-786-2281'}], 'facility': 'Centers for Medicare and Medicaid Services', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'centralContacts': [{'name': 'CMS CAG', 'role': 'CONTACT', 'email': 'CMS_caginquiries@cms.hhs.gov', 'phone': '410-786-2281'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centers for Medicare and Medicaid Services/ Coverage and Analysis Group', 'class': 'FED'}, 'responsibleParty': {'type': 'SPONSOR'}}}}