Ignite Creation Date:
2025-12-24 @ 6:29 PM
Ignite Modification Date:
2025-12-30 @ 9:19 AM
Study NCT ID:
NCT02249468
Status:
TERMINATED
Last Update Posted:
2017-03-03
First Post:
2014-08-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Exploratory Study to Compare the Differences in Nutritional Status Between Patients With Mild and Moderate Alzheimer's Disease (AD) and Cognitively Intact Healthy People in an Asian Population
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Plasma samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 191}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Stop the study for futility based on recommendation from Independent Data Committee.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-02', 'studyFirstSubmitDate': '2014-08-27', 'studyFirstSubmitQcDate': '2014-09-23', 'lastUpdatePostDateStruct': {'date': '2017-03-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uridine', 'timeFrame': '1 day', 'description': 'To look at nutritional Status in the blood'}, {'measure': 'Serum Phospholipids and Fatty Acid Profile', 'timeFrame': '1 day', 'description': 'Serum Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid\n\nTo look at nutritional Status in the blood'}, {'measure': 'Red Blood Cell Phospholipids and fatty acid profile', 'timeFrame': '1 day', 'description': 'Red Blood Cell Phospholipids, fatty acid profile e.g. docosahexaenoic acid / eicosapentaenoic acid / phosphatidylcholine docosahexaenoic acid\n\nTo look at nutritional Status in the blood'}, {'measure': 'Plasma polar lipid profile', 'timeFrame': '1 day', 'description': 'Plasma polar lipid profile including several types of phospholipids and their specific species; and cholesterol-esters\n\nTo look at nutritional Status in the blood'}, {'measure': 'Choline', 'timeFrame': '1 day', 'description': 'To look at nutritional Status in the blood'}, {'measure': 'Homocysteine', 'timeFrame': '1 day', 'description': 'To look at nutritional Status in the blood'}, {'measure': 'Vitamin B6', 'timeFrame': '1 day', 'description': 'To look at nutritional Status in the blood'}, {'measure': 'Folate', 'timeFrame': '1 day', 'description': 'To look at nutritional Status in the blood'}, {'measure': 'Vitamin B12', 'timeFrame': '1 day', 'description': 'To look at nutritional Status in the blood'}, {'measure': 'Selenium', 'timeFrame': '1 day', 'description': 'To look at nutritional Status in the blood'}, {'measure': 'Vitamin E', 'timeFrame': '1 day', 'description': 'To look at nutritional Status in the blood'}, {'measure': 'Vitamin D', 'timeFrame': '1 day', 'description': 'To look at nutritional Status in the blood'}, {'measure': 'HbA1C (haemoglobin A1C )', 'timeFrame': '1 day', 'description': 'Other blood parameters'}, {'measure': 'Liver Function - Alanine Aminotransferase and Aspartate Aminotransferase', 'timeFrame': '1 day', 'description': 'Other blood parameters'}, {'measure': 'Kidney function - Creatinine', 'timeFrame': '1 day', 'description': 'Other blood parameters'}, {'measure': 'Inflammatory marker', 'timeFrame': '1 day', 'description': 'C-reactive protein analysed using high sensitive C-reactive protein'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Mild and Moderate Alzheimer's Disease", 'Cognitively Healthy People']}, 'descriptionModule': {'briefSummary': "Difference in nutritional status between patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people in an Asian population", 'detailedDescription': 'The main objective of the current Asian nutritional status study is to get more insight into the nutritional status of AD patients in an Asian population in Asia. Plasma levels of several micronutrients and the fatty acid profile will be compared between patients with mild and moderate AD and cognitively intact healthy controls in an Asian population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Patients with mild and moderate Alzheimer's Disease (AD) and cognitively intact healthy people", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 50 years old\n* Asian ethnicity\n* Group 1: Cognitively intact healthy volunteers defined by Cumulative Illness Rating Scale for Geriatrics rating of ≤ 2 for all categories except for the category "psychiatric illness" which should have a rating of 0 and a CDR of 0 within 1 year prior to the visit.\n\nOR\n\nGroup 2a: AD patients clinically diagnosed with mild AD (according to the National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer\'s Disease and Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-1\n\nOR\n\nGroup 2b: AD patients clinically diagnosed with moderate AD (according to the National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer\'s Disease and Related Disorders criteria (McKhann et al., 1984)) with Clinical Dementia Rating-2\n\n\\- Written informed consent provided according to local regulations.\n\nExclusion Criteria:\n\n* Group 1 only: Current diagnosis of AD or other dementias according to National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer\'s Disease and Related Disorders criteria (McKhann et al.,1984 )\n* Group 2 only: Change in dose within 2 months prior to visit of AD medication (e.g. donepezil, rivastigmine, galantamine or memantine)\n\nGroup 1 and 2:\n\n* Diagnosis of significant neurological disease (for Groups 2a and 2b: other than AD), including vascular dementia according to National Institute of Neurological and Communicative Disorders, and Stroke-Alzheimer\'s Disease and Related Disorders criteria, cerebral tumour, Huntington\'s Disease, Parkinson\'s Disease, normal pressure hydrocephalus, seizures, major depression, schizophrenia and other entities\n* Use of vitamins supplements (only vitamins supplements C and D are allowed) for 3 months prior to the visit\n* Use of vitamin B injections\n* Alcohol or drug abuse as per investigator\'s judgement\n* Investigator\'s uncertainty about the willingness or ability of the patient to comply with the protocol requirements\n* Participation in any other studies involving investigational or marketed products concomitantly or within two weeks prior to entry into the study'}, 'identificationModule': {'nctId': 'NCT02249468', 'briefTitle': "An Exploratory Study to Compare the Differences in Nutritional Status Between Patients With Mild and Moderate Alzheimer's Disease (AD) and Cognitively Intact Healthy People in an Asian Population", 'organization': {'class': 'INDUSTRY', 'fullName': 'Danone Nutricia Research'}, 'officialTitle': "An Exploratory Study to Compare the Differences in Nutritional Status Between Patients With Mild and Moderate Alzheimer's Disease (AD) and Cognitively Intact Healthy People in an Asian Population", 'orgStudyIdInfo': {'id': 'Alz.1.C/O/0'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Mild and Moderate Alzheimer's Disease"}, {'label': 'Cognitively intact healthy people'}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Danone Nutricia Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}