Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2026-02-21 @ 10:12 PM
Study NCT ID:
NCT06508268
Status:
RECRUITING
Last Update Posted:
2024-07-18
First Post:
2024-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Language, Speech and Motor Function in MCI Due to AD and Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D007802', 'term': 'Language'}, {'id': 'D013060', 'term': 'Speech'}], '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': 'D003142', 'term': 'Communication'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D014705', 'term': 'Verbal Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 208}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-12', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-02-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-07-17', 'lastUpdatePostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Language and speech characteristics of spontaneous speech', 'timeFrame': '4 months', 'description': 'Autobiographical semi-structured interview and a picture description task ("The Cookie Theft Picture (Berube et al., 2019))'}, {'measure': 'Verbal fluency', 'timeFrame': '4 months', 'description': 'Naming animals and professions'}, {'measure': 'Letter fluency', 'timeFrame': '4 months', 'description': 'Naming letters starting with the letters D and A'}, {'measure': 'Temporal and spatial parameters of gait', 'timeFrame': '4 months', 'description': 'Gaitrite walkway system (GAITRite) or 4-meter walking speed test'}, {'measure': 'Hand grip strength', 'timeFrame': '4 months', 'description': 'Jamar hand dynamometer'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'MCI due to AD', 'Language', 'Speech', 'Motor', 'Gait', 'Hand grip strength', 'Fluency'], 'conditions': ["Alzheimer's Disease", 'MCI Due to AD', 'Dementia Alzheimers']}, 'descriptionModule': {'briefSummary': 'The goal of this observational cross-sectional study is to explore the characteristics of language, speech, and motor function in persons with Mild Cognitive Impairment due to Alzheimer\'s disease ("MCI due to AD") and persons with mild and moderate Alzheimer\'s disease ("AD"). This study aims to:\n\n* Explore motor, speech, and language functions in MCI due to AD and mild and moderate AD.\n* Combine the characteristics of motor, language, and speech functions to gain more insight into the association of language, speech, and motor changes during MCI due to AD and mild and moderate AD.\n\nResearchers will compare the outcomes to an age-matched control group without cognitive impairment.\n\nParticipants will undergo:\n\n* Two motor function tests to assess gait and hand grip strength.\n* Four language and speech function tests to assess spontaneous speech and verbal fluency..'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The envisaged total participants of this study is: 52 persons with MCI due to AD, 52 persons with mild AD, 52 persons with moderate AD, 52 and 52 age-matched persons without cognitive impairment. The first language of the participants is either Frisian and/or Dutch. The participants may in addition to that also speak a Dutch dialect or another language', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nA subject with MCI with a likelihood of underlying AD pathophysiology must meet the following criteria:\n\n* Established diagnosis of MCI due to AD with a likelihood according to NIA-AA criteria (Albert et al., 2011).\n* A score of stage three on the Global Deterioration Scale (GDS) (Reisberg et al., 1982).\n\nA subject with AD must meet the following criteria:\n\n* Established diagnosis of AD (amnestic or non-amnestic) or etiologically mixed presentation of AD according to DSM-5 (American Psychiatric Association, 2013) or NINCDS-ARDRA criteria (Jack et al., 2018; McKann et al., 2011).\n* The following scores on the Global Deterioration Scale (GDS): four for mild AD, five for moderate AD (Reisberg et al., 1982).\n\nAll subjects of the control group must meet the following criteria:\n\n* A score of stage one or two on the Global Deterioration Scale (GDS) (Reisberg et al., 1982).\n* They are age-matched with the MCI due to AD or AD patients included in the study.\n\nAll subjects must meet the following criteria:\n\n* First language is Dutch and/or Frisian.\n* Able to walk independently with or without walking aid.\n* Able to squeeze with each hand.\n\nExclusion Criteria:\n\nA subject with MCI due to AD or AD who meets the following criteria will be excluded from participation in this study:\n\n* Having a neurological or neurodegenerative disease or disorder that may be contributing to cognitive impairment above and beyond that caused by AD or mixed AD; Down's syndrome, other subtypes of dementia, autism spectrum disorder.\n* Having an established diagnosis of a psychiatric disorder, e.g. schizophrenia, depression.\n\nAll subjects in the control group who meets following criteria will be excluded from participation in this study:\n\n● Suffers from a neurological, neurodegenerative or psychiatric disease or disorder.\n\nAll subjects in any group who meet any of the following criteria will be excluded from participation in this study:\n\n* Hearing loss (with or without hearing aid) that affects communication.\n* Vision loss (with or without glasses or lenses) that affects communication.\n* History of language problems, speech problems or dyslexia.\n* Suffers from additional disorders or diseases which may limit gait, hand grip strength, language and/or speech.\n* Medication use that influence gait, hand grip strength, speech or language performance at time of testing.\n* Being terminally ill (i.e., life expectancy \\< 2 weeks according to the attending physician)."}, 'identificationModule': {'nctId': 'NCT06508268', 'briefTitle': "Language, Speech and Motor Function in MCI Due to AD and Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Hanze University of Applied Sciences Groningen'}, 'officialTitle': "Language, Speech and Motor Function in Mild Cognitive Impairment Due to AD and Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'NL79836.042.23'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Persons with Mild Cognitive Impairment due to AD', 'interventionNames': ['Behavioral: GAITRite walkway system OR 4-meter walking speed test', 'Behavioral: Jamar hand dynamometer', 'Behavioral: Picture description task', 'Behavioral: Autobiographical semi-structured conversation', 'Behavioral: Verbal fluency']}, {'label': 'Persons with mild AD', 'interventionNames': ['Behavioral: GAITRite walkway system OR 4-meter walking speed test', 'Behavioral: Jamar hand dynamometer', 'Behavioral: Picture description task', 'Behavioral: Autobiographical semi-structured conversation', 'Behavioral: Verbal fluency']}, {'label': 'Persons with moderate AD', 'interventionNames': ['Behavioral: GAITRite walkway system OR 4-meter walking speed test', 'Behavioral: Jamar hand dynamometer', 'Behavioral: Picture description task', 'Behavioral: Autobiographical semi-structured conversation', 'Behavioral: Verbal fluency']}, {'label': 'Persons without cognitive impairment, age-matched with persons with MCI due to AD and AD', 'interventionNames': ['Behavioral: GAITRite walkway system OR 4-meter walking speed test', 'Behavioral: Jamar hand dynamometer', 'Behavioral: Picture description task', 'Behavioral: Autobiographical semi-structured conversation', 'Behavioral: Verbal fluency']}], 'interventions': [{'name': 'GAITRite walkway system OR 4-meter walking speed test', 'type': 'BEHAVIORAL', 'description': 'Gait will be assessed by the GAITRite walkway system OR the 4-meter walking speed test', 'armGroupLabels': ['Persons with Mild Cognitive Impairment due to AD', 'Persons with mild AD', 'Persons with moderate AD', 'Persons without cognitive impairment, age-matched with persons with MCI due to AD and AD']}, {'name': 'Jamar hand dynamometer', 'type': 'BEHAVIORAL', 'description': 'Hand grip strength will be assessed by a Jamar hand dynamometer', 'armGroupLabels': ['Persons with Mild Cognitive Impairment due to AD', 'Persons with mild AD', 'Persons with moderate AD', 'Persons without cognitive impairment, age-matched with persons with MCI due to AD and AD']}, {'name': 'Picture description task', 'type': 'BEHAVIORAL', 'otherNames': ['Cookie Theft Picture'], 'description': 'Characteristics Dutch/Frisian language Language and speech will be assessed by the Cookie Theft Picture-task (a picture description task from Berube et al., 2019)', 'armGroupLabels': ['Persons with Mild Cognitive Impairment due to AD', 'Persons with mild AD', 'Persons with moderate AD', 'Persons without cognitive impairment, age-matched with persons with MCI due to AD and AD']}, {'name': 'Autobiographical semi-structured conversation', 'type': 'BEHAVIORAL', 'description': 'Characteristics Dutch/Frisian language and speech will be assessed by an autobiographical semi-structured conversation', 'armGroupLabels': ['Persons with Mild Cognitive Impairment due to AD', 'Persons with mild AD', 'Persons with moderate AD', 'Persons without cognitive impairment, age-matched with persons with MCI due to AD and AD']}, {'name': 'Verbal fluency', 'type': 'BEHAVIORAL', 'description': 'The mental lexicon of Dutch/Frisian language will be assessed by a two verbal fluency tests, including letter fluency and categorical fluency', 'armGroupLabels': ['Persons with Mild Cognitive Impairment due to AD', 'Persons with mild AD', 'Persons with moderate AD', 'Persons without cognitive impairment, age-matched with persons with MCI due to AD and AD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9714CA', 'city': 'Groningen', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'Oegema Marlies, Master', 'role': 'CONTACT', 'email': 'm.oegema@pl.hanze.nl', 'phone': '0031505953730'}], 'facility': 'Hanze University', 'geoPoint': {'lat': 53.21917, 'lon': 6.56667}}], 'centralContacts': [{'name': 'Marlies Oegema, Master', 'role': 'CONTACT', 'email': 'm.oegema@pl.hanze.nl', 'phone': '0031+0505953730'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': "This study is based on FAIR principles (Findable, Accessible, Interoperable and Reusable). This means that, all anonymized data and meta-data will be archived and shared during or after 5 years after completion of this study in one or more of the following database systems: Faith Research (https://www.faithresearch.nl/), DANS ('Data Archiving and Networked Services) and DataverseNL (https://dataverse.nl)."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hanze University of Applied Sciences Groningen', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Groningen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hans Hobbelen', 'investigatorAffiliation': 'Hanze University of Applied Sciences Groningen'}}}}