Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT05672732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-06-18
First Post:
2023-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Assessment of Clinical Trial Experiences of Alzheimer's Disease Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], '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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-01-02', 'size': 68119, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-01-03T03:14', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-06-15', 'studyFirstSubmitDate': '2023-01-03', 'studyFirstSubmitQcDate': '2023-01-03', 'lastUpdatePostDateStruct': {'date': '2023-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Rate of patients who decide to enroll in a Alzheimer's Disease Clinical Trial", 'timeFrame': '3 months'}, {'measure': "Number of patients who remain in Alzheimer's Disease clinical trial until completion", 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alzheimer Disease', "Alzheimer's"], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '29614878', 'type': 'BACKGROUND', 'citation': "Eratne D, Loi SM, Farrand S, Kelso W, Velakoulis D, Looi JC. Alzheimer's disease: clinical update on epidemiology, pathophysiology and diagnosis. Australas Psychiatry. 2018 Aug;26(4):347-357. doi: 10.1177/1039856218762308. Epub 2018 Apr 3."}, {'pmid': '20610346', 'type': 'BACKGROUND', 'citation': "Mangialasche F, Solomon A, Winblad B, Mecocci P, Kivipelto M. Alzheimer's disease: clinical trials and drug development. Lancet Neurol. 2010 Jul;9(7):702-16. doi: 10.1016/S1474-4422(10)70119-8."}, {'pmid': '30560544', 'type': 'BACKGROUND', 'citation': "Rafii MS, Aisen PS. Alzheimer's Disease Clinical Trials: Moving Toward Successful Prevention. CNS Drugs. 2019 Feb;33(2):99-106. doi: 10.1007/s40263-018-0598-1."}]}, 'descriptionModule': {'briefSummary': "Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.\n\nThis study will admit a wide range of data on the clinical trial experience of Alzheimer's Disease patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.\n\nIt will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future Alzheimer's Disease patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Alzheimer's Disease patients who are actively considering involvement in an interventional clinical trial, but have not yet completed enrollment and registration.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is at least 50 to 80 years of age\n* Participant has a diagnosis of Alzheimer's Disease\n* Patient has self-identified as planning to enroll in an interventional clinical trial for Alzheimer's Disease\n\nExclusion Criteria:\n\n* No diagnosis of Alzheimer's Disease confirmed\n* Inability to perform regular electronic reporting\n* Patient does not understand, sign, and return consent form"}, 'identificationModule': {'nctId': 'NCT05672732', 'briefTitle': "Assessment of Clinical Trial Experiences of Alzheimer's Disease Patients", 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': "In Depth Observational Clinical Trial Assessing Experiences of Alzheimer's Disease Patients To Determine Trial Attributes Affecting Completion Rates For Specific Demographic Groups", 'orgStudyIdInfo': {'id': '81466128'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '415-900-4227'}], 'overallOfficials': [{'name': 'Michael B Gill', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Power Life Sciences Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Power Life Sciences Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}