Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-26 @ 4:59 AM
Study NCT ID:
NCT05484960
Status:
UNKNOWN
Last Update Posted:
2022-08-02
First Post:
2022-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Philippine Neurological Association One Database -Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073216', 'term': 'Mental Status and Dementia Tests'}], 'ancestors': [{'id': 'D009483', 'term': 'Neuropsychological Tests'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 73}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-31', 'studyFirstSubmitDate': '2022-07-17', 'studyFirstSubmitQcDate': '2022-07-31', 'lastUpdatePostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of dementia and mild cognitive impairment in the study population', 'timeFrame': 'on Day 1', 'description': 'To determine the frequency of dementia and mild cognitive impairment in the study'}], 'secondaryOutcomes': [{'measure': 'F frequency of the different types of dementia in the study population', 'timeFrame': 'on Day 1', 'description': 'To determine the frequency of the different types of dementia in the study population using the clinical diagnosis'}, {'measure': 'Frequency of risk factors for dementia in the study population', 'timeFrame': 'on Day 1', 'description': 'o determine the frequency of risk factors for dementia in the study population. (age, sex, educational attainment, family history, physical activity, smoking history, alcohol consumption, cardiovascular and cerebrovascular risk factors, chemical exposure, substance abuse, previous psychiatric condition and hearing impairment)'}, {'measure': 'Demographic characteristics of patients with dementia or mild cognitive impairment', 'timeFrame': 'on Day 1', 'description': 'To describe the demographic characteristics of patients with dementia or mild cognitive impairment as to age at the time of diagnosis, age of onset of symptoms, sex, level of income (of patient or caregiver), location of clinic or hospital, current or previous occupation, educational attainment, neurologic exam findings'}, {'measure': 'Dementia Severity', 'timeFrame': 'on Day 1', 'description': 'To categorize dementia severity in each subtype as mild, moderate and severe based on the initial MMSE score at the time of diagnosis.'}, {'measure': 'Diagnostic tests used at the time of the diagnosis', 'timeFrame': 'on Day 1', 'description': 'To describe the types of diagnostic tests commonly done at the time of diagnosis, such as neuroimaging, blood tests, EEG'}, {'measure': 'Pharmacologic and nonpharmacologic modalities used', 'timeFrame': 'on Day 1', 'description': 'To identify pharmacologic and nonpharmacologic modalities of treatment currently being used in the treatment of dementia'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Cognitive Impairment', 'Dementia', 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'This is a pragmatic, multi-center, prospective, observational, non-interventional study and standing database of patients seen at the training institution for cognitive impairment diagnosed with Mild Cognitive Impairment (MCI) or Dementia.\n\nAll patients seen at the training institution clinically diagnosed with MCI or dementia by their neurologists will be invited to participate in the study. The investigators will confirm the diagnosis and will explain the study as well as the patient information sheet to the patient and/or legal representative. All eligible patients seen will be assigned a study identification number. Data will be collected by the investigators as the patient undergoes routine clinical evaluation. Corresponding anonymized data on demographics, medical history and risk factors, level of functional impairment, diagnosis, baseline cognitive scores and management will be collected from each patient and entered in the database using a secure online data collection tool.', 'detailedDescription': 'The investigators will confirm the diagnosis and will explain the study as well as the patient information sheet to the patient and/or legal representative. All eligible patients seen will be assigned a study identification number. Data will be collected by the investigators as the patient undergoes routine clinical evaluation. Corresponding anonymized data on demographics, medical history and risk factors, level of functional impairment, diagnosis, baseline cognitive scores and management will be collected from each patient and entered in the database using a secure online data collection tool. Patients who withdraw participation verbally or in writing are excluded by the investigator from further participation. Withdrawal from the study will be properly documented, including date, time, and reason for withdrawal. Withdrawn subjects will not have their clinical data included in the database.\n\nCollective data will be extracted, summarized, and analyzed every year with oversight provided by the Philippine Neurological Association (PNA). To be able to assess trends and changes over time, data collection for this study will span 3 years from study initiation, after which the utility of an extension or a re-implementation of the study will be assessed by the PNA.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients seen and evaluated at the participating sites are eligible to be included in the study if they fulfill all inclusion and none of the exclusion criteria.', 'eligibilityCriteria': "Inclusion Criteria\n\n* Patient with cognitive impairment diagnosed with Mild Cognitive Impairment or Dementia.\n* 18 years old or older.\n* Must be a Filipino Citizen.\n* Seen and evaluated in the participating hospital by a neurologist.\n* If required by the institutional review board/ethics committee, signed or verbal informed consent for participation in the study from the patient or a legal representative.\n\nExclusion Criteria\n\n• Any condition which, in the study investigator's opinion, may jeopardize the patient by his/her participation in this study or affect the validity of the study results."}, 'identificationModule': {'nctId': 'NCT05484960', 'acronym': 'PNA1DB-Dem', 'briefTitle': 'The Philippine Neurological Association One Database -Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Philippine Neurological Association'}, 'officialTitle': 'Multicenter Collection of Uniform Data on Patients With Cognitive Impairment in the Philippines: the Philippine Neurological Association One Database -Dementia (PNA1DB-Dementia)', 'orgStudyIdInfo': {'id': 'PNA2020_0X'}}, 'armsInterventionsModule': {'interventions': [{'name': 'cognitive assessment', 'type': 'OTHER', 'description': 'The clinical diagnosis will be made based on the criteria set by the investigators. Clinical history and bedside objective assessment in the form of Montreal Cognitive Assessment-Philippines (MoCA-P) or Mini Mental Status Examination-Philippines (MMSE-P), supported by a neuroimaging study (if neuroimaging is not done, diagnosis will be supported by the Hachinski Ischemic Score).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Baguio City', 'state': 'Baguio', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Debbie Liquete, MD', 'role': 'CONTACT', 'email': 'debzliquete1979@gmail.com'}, {'name': 'Debbie Liquete, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Baguio General Hospital and Medical Center', 'geoPoint': {'lat': 16.41639, 'lon': 120.59306}}, {'city': 'Cebu City', 'state': 'Cebu', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Virginia Espanol, MD', 'role': 'CONTACT', 'email': 'virginiaespanol@gmail.com'}, {'name': 'Virginia Espanol, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Chong Hua Hospital', 'geoPoint': {'lat': 10.31672, 'lon': 123.89071}}, {'city': 'Makati City', 'state': 'National Capital Region', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Donnabelle Chu, MD', 'role': 'CONTACT', 'email': 'donnabelle.chu@gmail.com'}, {'name': 'Donnabelle Chu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Makati Medical Center', 'geoPoint': {'lat': 14.55027, 'lon': 121.03269}}, {'city': 'Pasig', 'state': 'National Capital Region', 'status': 'NOT_YET_RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Grace Orteza, MD', 'role': 'CONTACT', 'email': 'GOOneuroconsult@gmail.com'}, {'name': 'Grace Orteza, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The Medical City', 'geoPoint': {'lat': 14.58691, 'lon': 121.0614}}, {'city': 'Quezon City', 'state': 'National Capital Region', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Marissa Ong, MD', 'role': 'CONTACT', 'email': 'marissaong115@gmail.com'}, {'name': 'Marissa Ong, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'East Avenue Medical Center', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'state': 'National Capital Region', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Jemelle Cano, MD', 'role': 'CONTACT', 'email': 'jcano@stlukes.com.ph'}, {'name': 'Jemelle Cano, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Quirino Memorial Medical Center', 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'city': 'Quezon City', 'state': 'National Capital Region', 'status': 'NOT_YET_RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Jacqueline Dominguez, MD', 'role': 'CONTACT', 'email': 'jcdominguez@stlukes.com.ph'}, {'name': 'Jacqueline Dominguez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "St. Luke's Medical Center", 'geoPoint': {'lat': 14.6488, 'lon': 121.0509}}, {'zip': '1008', 'city': 'Manila', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Joseree Catindig, MD', 'role': 'CONTACT', 'email': 'jscatindig@ust.edu.ph'}, {'name': 'Joseree Catindig', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Jose R. Reyes Memorial Medical Center', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'zip': '1008', 'city': 'Manila', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Encarnita R Ampil, MD', 'role': 'CONTACT', 'email': 'erampil@ust.edu.ph', 'phone': '(02)7313001'}, {'name': 'Encarnita R Ampil, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Santo Tomas Hospiatl', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'status': 'RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Stephanie Badillo, MD', 'role': 'CONTACT', 'email': 'stephjordan.md@gmail.com'}, {'name': 'Stephanie Badillo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of the East- Ramon Magsaysay Memorial Medical Center', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}, {'city': 'Manila', 'status': 'NOT_YET_RECRUITING', 'country': 'Philippines', 'contacts': [{'name': 'Alvin Cenina, MD', 'role': 'CONTACT'}, {'name': 'afcenina@up.edu.ph', 'role': 'CONTACT'}, {'name': 'Alvin Cenina, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of the Philippines - Philippine General Hospital', 'geoPoint': {'lat': 14.6042, 'lon': 120.9822}}], 'centralContacts': [{'name': 'Rosalina Picar, MD', 'role': 'CONTACT', 'email': 'repicarmd@yahoo.com', 'phone': '(02)87232102'}], 'overallOfficials': [{'name': 'Ma. Lourdes C Joson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Philippine Neurological Association'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'To be available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Philippine Neurological Association', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Santo Tomas Hospital, Philippines', 'class': 'OTHER'}, {'name': 'Baguio General Hospital and Medical Center, Philippines', 'class': 'UNKNOWN'}, {'name': 'East Avenue Medical Center, Philippines', 'class': 'OTHER_GOV'}, {'name': 'Jose R. Reyes Memorial Medical Center', 'class': 'OTHER_GOV'}, {'name': 'Makati Medical Center', 'class': 'OTHER'}, {'name': 'Quirino Memorial Medical Center, Philippines', 'class': 'UNKNOWN'}, {'name': "St. Luke's Medical Center, Philippines", 'class': 'OTHER'}, {'name': 'The Medical City, Philippines', 'class': 'OTHER'}, {'name': 'University of the East- Ramon Magsaysay Memorial Medical Center, Philippines', 'class': 'UNKNOWN'}, {'name': 'University of the Philippines Manila - Philippine General Hospital', 'class': 'OTHER'}, {'name': 'Chong Hua Hospital, Philippines', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}