Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2025-12-27 @ 3:28 AM
Study NCT ID:
NCT06218732
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2024-01-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Revealing Engagement Dynamics Among Semantic Dementia Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057180', 'term': 'Frontotemporal Dementia'}], 'ancestors': [{'id': 'D057174', 'term': 'Frontotemporal Lobar Degeneration'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D057177', 'term': 'TDP-43 Proteinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-12', 'size': 75644, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-01-12T06:22', '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': '2024-01-12', 'studyFirstSubmitDate': '2024-01-12', 'studyFirstSubmitQcDate': '2024-01-12', 'lastUpdatePostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of patients who decide to enroll in a semantic dementia clinical research.', 'timeFrame': '3 months'}, {'measure': 'Number of semantic dementia study participants who remain in clinical study until completion.', 'timeFrame': '12 months'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Semantic Dementia'], 'conditions': ['Semantic Dementia']}, 'referencesModule': {'references': [{'pmid': '33966130', 'type': 'BACKGROUND', 'citation': 'Paplikar A, Vandana VP, Mekala S, Darshini KJ, Arshad F, Iyer GK, Kandukuri R, Divyaraj G, Varghese F, Kaul S, Patterson K, Alladi S. Semantic memory impairment in dementia: A cross-cultural adaptation study. Neurol Sci. 2022 Jan;43(1):265-273. doi: 10.1007/s10072-021-05272-5. Epub 2021 May 8.'}, {'pmid': '20385916', 'type': 'BACKGROUND', 'citation': 'Kertesz A, Jesso S, Harciarek M, Blair M, McMonagle P. What is semantic dementia?: a cohort study of diagnostic features and clinical boundaries. Arch Neurol. 2010 Apr;67(4):483-9. doi: 10.1001/archneurol.2010.55.'}, {'pmid': '34627361', 'type': 'BACKGROUND', 'citation': 'Sato S, Hashimoto M, Yoshiyama K, Kanemoto H, Hotta M, Azuma S, Suehiro T, Kakeda K, Nakatani Y, Umeda S, Fukuhara R, Takebayashi M, Ikeda M. Characteristics of behavioral symptoms in right-sided predominant semantic dementia and their impact on caregiver burden: a cross-sectional study. Alzheimers Res Ther. 2021 Oct 9;13(1):166. doi: 10.1186/s13195-021-00908-2.'}]}, 'descriptionModule': {'briefSummary': "The study intends to investigate the personal experiences of semantic dementia patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.\n\nThe data collected from this study will help improve future outcomes for all semantic dementia as well as those in under-represented demographic groups."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with semantic dementia who are actively considering enrolling in a clinical trial for said condition, but have not yet completed enrollment and randomization phases.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with semantic dementia\n* Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed\n* Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.\n\nExclusion Criteria:\n\n* Refusal of consent\n* Women of childbearing potential without a negative pregnancy test; or women who are lactating.\n* Any serious and/or unstable pre-existing medical disorders'}, 'identificationModule': {'nctId': 'NCT06218732', 'briefTitle': 'Revealing Engagement Dynamics Among Semantic Dementia Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Power Life Sciences Inc.'}, 'officialTitle': 'Understanding Participation Habits: An Observational Investigation Within Semantic Dementia Clinical Trials', 'orgStudyIdInfo': {'id': '58672364'}}, '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': '(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'}}}}