Ignite Creation Date:
2025-12-24 @ 5:02 PM
Ignite Modification Date:
2025-12-28 @ 11:37 PM
Study NCT ID:
NCT04949750
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-11
First Post:
2021-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-09', 'studyFirstSubmitDate': '2021-06-19', 'studyFirstSubmitQcDate': '2021-06-30', 'lastUpdatePostDateStruct': {'date': '2025-04-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in the Mini-Mental State Examination (MMSE)', 'timeFrame': '12 weeks from baseline cognitive assessment', 'description': 'It is a 30-point questionnaire that is used extensively in clinical and research settings to measure cognitive impairment. The score is between 0-30. Higher score indicating better cognition.'}, {'measure': 'Change from baseline in the Memory tests', 'timeFrame': '12 weeks from baseline cognitive assessment', 'description': 'Immediate Recall, Delayed Recall, Delayed Recognition are tests that measure memory function. Higher score indicating better cognition.'}, {'measure': 'Change from baseline in the Trail Making test scores', 'timeFrame': '12 weeks from baseline cognitive assessment', 'description': 'Raw score, assessing attention, executive function. TMT is divided into two parts, TMT-A and TMT-B. In the TMT part A, circles with number from 1 to 25 are arranged randomly. Numerical sequence should be connected by patients as quickly as possible, cutoff value \\> 180 seconds. In the TMT part B, patients must alternate between numbers and letters, cut off value \\> 300 second. Cutoff scores indicate the value above suggest cognitive performance is normal.'}, {'measure': 'Change from baseline in the Digits Span forward and backward', 'timeFrame': '12 weeks from baseline cognitive assessment', 'description': 'The longest digits of forward and backward are 8 and 7, respectively. The total scores are twelve for each test. Higher score indicating better cognition.'}, {'measure': 'Change from baseline in the Verbal fluency test', 'timeFrame': '12 weeks from baseline cognitive assessment', 'description': "Semantic memory score will be measured using the Verbal fluency test. The verbal fluency test is a short test of verbal functioning. Participants are given 1 min to produce as many animals as possible within a semantic category (category fluency). The participant's score is the number of animals. Higher score means better cognition."}, {'measure': 'Change from baseline in the Clock drawing test', 'timeFrame': '12 weeks from baseline cognitive assessment', 'description': '1-6 points, with higher scores indicating worse visuo-spatial function.'}, {'measure': 'Change from baseline in the 15-Item Version of the Boston Naming Test', 'timeFrame': '12 weeks from baseline cognitive assessment', 'description': 'Cognitive test of semantic memory. Object naming to confrontation, which also depends upon intact perceptual and word retrieval ability. Higher scores indicating better cognition.'}, {'measure': 'Change from baseline in the Instrumental Activities of Daily Living (IADL) score.', 'timeFrame': '12 weeks from baseline cognitive assessment', 'description': "Instrumental Activities of Daily Living (IADL) is a questionnaire to assess patient's capacity to live independently."}], 'secondaryOutcomes': [{'measure': 'Change from baseline in the Zarit Burden Interview (ZBI) score.', 'timeFrame': '12 weeks from baseline cognitive assessment', 'description': "Zarit Burden Interview score is a questionnaire to assess patient's caregiver burden."}, {'measure': 'Percentage of participants completes the full 12-week cognitive training.', 'timeFrame': '12 weeks from baseline cognitive assessment', 'description': 'Every 4 weeks participants will follow-up at Dementia Center and be able to continue the training if they complete 80% of each level of difficulty workload. Therefore, we aim to calculate the percentage of participants who can completes the full 12-week cognitive training.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Early Alzheimer Disease', 'Paper - based cognitive training', 'Randomized trial'], 'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess the efficacy of paper-based cognitive training in Vietnamese patients with early Alzheimer's disease"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* For patient:\n\n * Diagnosis of Probable Alzheimer's Disease per DSM-5 criteria;\n * In the early stage of AD (MMSE from 20 to 25);\n * Age from 60 - 80 years old;\n * Had greater than 5 years of formal education.\n* For Caregiver:\n\n * Members (including, but not limited to partners, children, relatives, lived-in helper of the patient) that are important for care delivery and provide care-related tasks (eg personal care, eating, cooking, cleaning) and everyday decision making to the patients. They are not required to live together or spend a specific amount of time with the patients;\n * Older than 18 years of age;\n * Possess adequate Vietnamese language skills and no cognitive impairment to conduct interview and evaluation\n\nExclusion Criteria:\n\n* For patient:\n\n * Patients with concomitant diseases (heart failure, kidney failure, liver failure or thyroid diseases) that affect cognitive functions;\n * Diagnosed with significant neurologic disease other than AD (Parkinson's disease, multi-infarct dementia, schizophrenia, history of significant head trauma followed by persistent neurologic defaults, …), major depression within the past 1 year, or taking psychoactive medications (antidepressants with significant anticholinergic side effects, neuroleptics, chronic anxiolytics or sedative hypnotics, etc) within the past 1 month;\n * Having major visual, auditory, reading, or writing impairments;\n * Patients and/or caregivers who decline to participate.\n* For cargiver:\n\n * Having subjective complaints of cognitive impairment prevents them from understanding the instruction from the research team;\n * Having significant visual, auditory, reading, or writing impairments;\n * Caregivers who decline to participate"}, 'identificationModule': {'nctId': 'NCT04949750', 'briefTitle': "Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Medicine and Pharmacy at Ho Chi Minh City'}, 'officialTitle': "Efficacy of Paper-based Cognitive Training in Vietnamese Patients With Early Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'IRB-VNO1002'}, 'secondaryIdInfos': [{'id': 'R01AG064688', 'link': 'https://reporter.nih.gov/quickSearch/R01AG064688', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Paper based cognitive training', 'description': "Patients with Alzheimer's disease in the early stage receive 12 weeks paper based cognitive training and standard care (medication)", 'interventionNames': ['Other: Paper - based cognitive training']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': "Patients with Alzheimer's disease in the early stage only receive standard care (medication)"}], 'interventions': [{'name': 'Paper - based cognitive training', 'type': 'OTHER', 'otherNames': ['Non pharmacological treatment for AD'], 'description': 'Cognitive training', 'armGroupLabels': ['Paper based cognitive training']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70000', 'city': 'Ho Chi Minh City', 'country': 'Vietnam', 'facility': 'University Medical Center', 'geoPoint': {'lat': 10.82302, 'lon': 106.62965}}], 'overallOfficials': [{'name': 'Trang M. Tong, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Medicine and Pharmacy at Ho Chi Minh City'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Medicine and Pharmacy at Ho Chi Minh City', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of California, Davis', 'class': 'OTHER'}, {'name': 'National Geriatric Hospital', 'class': 'OTHER_GOV'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician, Neurology Department, University Medical Center, Ho Chi Minh City', 'investigatorFullName': 'Tống Mai Trang', 'investigatorAffiliation': 'University of Medicine and Pharmacy at Ho Chi Minh City'}}}}