Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-27 @ 7:16 PM
Study NCT ID:
NCT06207903
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-17
First Post:
2024-01-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Navigating the Clinical Research Process for Mild Cognitive Impairment
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'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-05', 'size': 62916, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-05T08:52', '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': '2025-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2027-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-05', 'studyFirstSubmitDate': '2024-01-05', 'studyFirstSubmitQcDate': '2024-01-05', 'lastUpdatePostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients who decide to enroll in a mild cognitive impairment clinical research.', 'timeFrame': '3 months'}, {'measure': 'Number of mild cognitive impairment study participants who remain in clinical study until completion.', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mild cognitive impairment'], 'conditions': ['Mild Cognitive Impairment']}, 'referencesModule': {'references': [{'pmid': '27042901', 'type': 'BACKGROUND', 'citation': 'Petersen RC. Mild Cognitive Impairment. Continuum (Minneap Minn). 2016 Apr;22(2 Dementia):404-18. doi: 10.1212/CON.0000000000000313.'}, {'pmid': '30370616', 'type': 'BACKGROUND', 'citation': 'Breton A, Casey D, Arnaoutoglou NA. Cognitive tests for the detection of mild cognitive impairment (MCI), the prodromal stage of dementia: Meta-analysis of diagnostic accuracy studies. Int J Geriatr Psychiatry. 2019 Feb;34(2):233-242. doi: 10.1002/gps.5016. Epub 2018 Nov 27.'}, {'pmid': '35680080', 'type': 'BACKGROUND', 'citation': "Chou YH, Sundman M, Ton That V, Green J, Trapani C. Cortical excitability and plasticity in Alzheimer's disease and mild cognitive impairment: A systematic review and meta-analysis of transcranial magnetic stimulation studies. Ageing Res Rev. 2022 Aug;79:101660. doi: 10.1016/j.arr.2022.101660. Epub 2022 Jun 6."}]}, 'descriptionModule': {'briefSummary': "Participation in medical research 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 trial will admit a wide range of data on the clinical trial experience of mild cognitive impairment 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 mild cognitive impairment patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Mild cognitive impairment patients who are actively considering participating in a clinical trial, but have not yet completed enrollment and randomization.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of mild cognitive impairment\n* Participant must be 18 years of age or older\n* Participant must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, and other requirements of the study.\n\nExclusion Criteria:\n\n* Pregnant or lactating woman\n* Participant is actively receiving study therapy in another\n* Inability to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT06207903', 'briefTitle': 'Navigating the Clinical Research Process for Mild Cognitive Impairment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'Investigating Participation Behavior: An Observational Study in Mild Cognitive Impairment Clinical Trials', 'orgStudyIdInfo': {'id': '58428170'}}, 'contactsLocationsModule': {'locations': [{'zip': '94107', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'contacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'https://www.withpower.com/contact-us@withpower.com', 'phone': '415-900-4227'}], 'facility': 'Power Life Sciences', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Michael B Gill', 'role': 'CONTACT', 'email': 'bask@withpower.com', 'phone': '4159004227'}], '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'}}}}