Language, Speech and Motor Function in MCI Due to AD and Alzheimer's Disease
NCT ID: NCT06508268
Last Updated: 2024-07-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
208 participants
OBSERVATIONAL
2024-07-12
2025-02-09
Brief Summary
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* Explore motor, speech, and language functions in MCI due to AD and mild and moderate AD.
* 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.
Researchers will compare the outcomes to an age-matched control group without cognitive impairment.
Participants will undergo:
* Two motor function tests to assess gait and hand grip strength.
* Four language and speech function tests to assess spontaneous speech and verbal fluency..
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Persons with Mild Cognitive Impairment due to AD
GAITRite walkway system OR 4-meter walking speed test
Gait will be assessed by the GAITRite walkway system OR the 4-meter walking speed test
Jamar hand dynamometer
Hand grip strength will be assessed by a Jamar hand dynamometer
Picture description task
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)
Autobiographical semi-structured conversation
Characteristics Dutch/Frisian language and speech will be assessed by an autobiographical semi-structured conversation
Verbal fluency
The mental lexicon of Dutch/Frisian language will be assessed by a two verbal fluency tests, including letter fluency and categorical fluency
Persons with mild AD
GAITRite walkway system OR 4-meter walking speed test
Gait will be assessed by the GAITRite walkway system OR the 4-meter walking speed test
Jamar hand dynamometer
Hand grip strength will be assessed by a Jamar hand dynamometer
Picture description task
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)
Autobiographical semi-structured conversation
Characteristics Dutch/Frisian language and speech will be assessed by an autobiographical semi-structured conversation
Verbal fluency
The mental lexicon of Dutch/Frisian language will be assessed by a two verbal fluency tests, including letter fluency and categorical fluency
Persons with moderate AD
GAITRite walkway system OR 4-meter walking speed test
Gait will be assessed by the GAITRite walkway system OR the 4-meter walking speed test
Jamar hand dynamometer
Hand grip strength will be assessed by a Jamar hand dynamometer
Picture description task
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)
Autobiographical semi-structured conversation
Characteristics Dutch/Frisian language and speech will be assessed by an autobiographical semi-structured conversation
Verbal fluency
The mental lexicon of Dutch/Frisian language will be assessed by a two verbal fluency tests, including letter fluency and categorical fluency
Persons without cognitive impairment, age-matched with persons with MCI due to AD and AD
GAITRite walkway system OR 4-meter walking speed test
Gait will be assessed by the GAITRite walkway system OR the 4-meter walking speed test
Jamar hand dynamometer
Hand grip strength will be assessed by a Jamar hand dynamometer
Picture description task
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)
Autobiographical semi-structured conversation
Characteristics Dutch/Frisian language and speech will be assessed by an autobiographical semi-structured conversation
Verbal fluency
The mental lexicon of Dutch/Frisian language will be assessed by a two verbal fluency tests, including letter fluency and categorical fluency
Interventions
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GAITRite walkway system OR 4-meter walking speed test
Gait will be assessed by the GAITRite walkway system OR the 4-meter walking speed test
Jamar hand dynamometer
Hand grip strength will be assessed by a Jamar hand dynamometer
Picture description task
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)
Autobiographical semi-structured conversation
Characteristics Dutch/Frisian language and speech will be assessed by an autobiographical semi-structured conversation
Verbal fluency
The mental lexicon of Dutch/Frisian language will be assessed by a two verbal fluency tests, including letter fluency and categorical fluency
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Established diagnosis of MCI due to AD with a likelihood according to NIA-AA criteria (Albert et al., 2011).
* A score of stage three on the Global Deterioration Scale (GDS) (Reisberg et al., 1982).
A subject with AD must meet the following criteria:
* 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).
* The following scores on the Global Deterioration Scale (GDS): four for mild AD, five for moderate AD (Reisberg et al., 1982).
All subjects of the control group must meet the following criteria:
* A score of stage one or two on the Global Deterioration Scale (GDS) (Reisberg et al., 1982).
* They are age-matched with the MCI due to AD or AD patients included in the study.
All subjects must meet the following criteria:
* First language is Dutch and/or Frisian.
* Able to walk independently with or without walking aid.
* Able to squeeze with each hand.
Exclusion Criteria
* 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.
* Having an established diagnosis of a psychiatric disorder, e.g. schizophrenia, depression.
All subjects in the control group who meets following criteria will be excluded from participation in this study:
● Suffers from a neurological, neurodegenerative or psychiatric disease or disorder.
All subjects in any group who meet any of the following criteria will be excluded from participation in this study:
* Hearing loss (with or without hearing aid) that affects communication.
* Vision loss (with or without glasses or lenses) that affects communication.
* History of language problems, speech problems or dyslexia.
* Suffers from additional disorders or diseases which may limit gait, hand grip strength, language and/or speech.
* Medication use that influence gait, hand grip strength, speech or language performance at time of testing.
* Being terminally ill (i.e., life expectancy \< 2 weeks according to the attending physician).
ALL
Yes
Sponsors
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University of Groningen
OTHER
Hanze University of Applied Sciences Groningen
OTHER
Responsible Party
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Hans Hobbelen
Professor
Locations
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Hanze University
Groningen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NL79836.042.23
Identifier Type: -
Identifier Source: org_study_id
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