Ignite Creation Date:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2026-01-22 @ 7:01 AM
Study NCT ID:
NCT03698760
Status:
COMPLETED
Last Update Posted:
2020-07-29
First Post:
2018-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computerized Olfactory Test - Alzheimer Disease Mild Stage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D000857', 'term': 'Olfaction Disorders'}], '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'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The study is a single-center controlled study (Jewish General Hospital, Montreal, Quebec, Canada), consisting of two groups of subjects: a control group and a group of subjects with mild Alzheimer's disease."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-28', 'studyFirstSubmitDate': '2018-10-02', 'studyFirstSubmitQcDate': '2018-10-04', 'lastUpdatePostDateStruct': {'date': '2020-07-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective test of evaluation of the olfactory sensitivity', 'timeFrame': '15 minutes', 'description': 'olfactory test (only one evaluation): random fragrances, recognition (Yes or No)'}], 'secondaryOutcomes': [{'measure': 'Health condition assessed by self-administered questionnaire (SAQ)', 'timeFrame': '10 minutes', 'description': 'self-administered questionnaire (SAQ), score between 0 and 18, a higher score means a higher frailty'}, {'measure': 'Objective test of evaluation of the olfactory thresholds', 'timeFrame': '15 minutes', 'description': 'olfactory test, 6 random fragrances among 14, recognition Yes or No and at what concentration'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease', 'Olfaction Disorders']}, 'descriptionModule': {'briefSummary': 'This study evaluates the effectiveness of the smell tests that are used in early diagnosis of mild dementia.', 'detailedDescription': "For twenty years research has shown a strong link between olfactory disorders and Alzheimer's disease. The focus is on the very early alteration of the olfaction which acts as a harbinger of the disease since it is detectable in its asymptomatic phase. In addition, olfactory involvement is a precursor to the transformation of mild cognitive impairment into MA. Indeed the anatomical structures the first lesions are located in the transentorhinal region of the temporal lobe and entorhinal phase, before progressing towards the limbic system, which will mark the clinical appearance of the first signs of AD.\n\nIn literature, it has been shown that there was no olfactory test that is recognized as a gold standard in the scientific community due to a lack of homogeneity of the tools used, their availability and their validity depending on the culture. Moreover, of all the tests currently available, none are specific to neurodegenerative diseases.\n\nVery recent studies show that there is also a strong preference for imaging tools or biomarkers in the detection of AD, but it appears that the olfactory disorders are well before these markers. It has been shown that an identification test is comparable in predictive accuracy to neuroimaging and cerebrospinal fluid sampling.\n\nThis study will therefore focus on the calibration and validation of a computerized olfactory test for the diagnosis of Alzheimer's disease and based the recommendations of professionals so as to promote the effective use of this test in clinical practice."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Being 60 years old and over\n* The participants enrolled in the control group must have a score of the Mini-Mental State Exam test greater than or equal to 28.\n* The participants enrolled in the intervention group must have a diagnosis of Alzheimer's disease, and the score of the Mini-Mental State Exam test should be between 20 and 27\n\nExclusion Criteria:\n\n* Presenting an unstable, acute or current psychiatric or physical condition that is severe enough to prevent the participant from participating in the study, as determined by the investigator.\n* Having an uncorrected major visual or hearing impairment or anosmia (total olfaction loss)."}, 'identificationModule': {'nctId': 'NCT03698760', 'briefTitle': 'Computerized Olfactory Test - Alzheimer Disease Mild Stage', 'organization': {'class': 'OTHER', 'fullName': 'Jewish General Hospital'}, 'officialTitle': "Calibration and Validation of a Computerized Olfactory Test in Subjects With Alzheimer's Disease in a Mild Stage", 'orgStudyIdInfo': {'id': '2019-1509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mild stage Alzheimer group', 'description': "Participants with mild stage Alzheimer's disease", 'interventionNames': ['Diagnostic Test: Olfactory test']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group', 'description': 'Participants without cognitive disorders', 'interventionNames': ['Diagnostic Test: Olfactory test']}], 'interventions': [{'name': 'Olfactory test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Olfactory test:\n\nAll fragrances tested are kept in an airtight case protected from cold and heat.\n\nThe test is done on a tablet and the data will be automatically saved. The first screen is about the administrative data, sex and age of the subject. Olfactory test: six odors among the fourteen are proposed in a randomized way.', 'armGroupLabels': ['Control Group', 'Mild stage Alzheimer group']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H3T 1E2', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Jewish General Hospital', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Olivier Beauchet, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jewish General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jewish General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Geriatrics', 'investigatorFullName': 'Olivier Beauchet', 'investigatorAffiliation': 'Jewish General Hospital'}}}}