Status:
RECRUITING
Language, Speech and Motor Function in MCI Due to AD and Alzheimer's Disease
Lead Sponsor:
Hanze University of Applied Sciences Groningen
Collaborating Sponsors:
University of Groningen
Conditions:
Alzheimer's Disease
MCI Due to AD
Eligibility:
All Genders
Brief Summary
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 ("MC...
Eligibility Criteria
Inclusion
- A subject with MCI with a likelihood of underlying AD pathophysiology must meet the following 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
- A subject with MCI due to AD or AD who meets the following criteria will be excluded from participation in this study:
- 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).
Key Trial Info
Start Date :
July 12 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 9 2025
Estimated Enrollment :
208 Patients enrolled
Trial Details
Trial ID
NCT06508268
Start Date
July 12 2024
End Date
February 9 2025
Last Update
July 18 2024
Active Locations (1)
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1
Hanze University
Groningen, Netherlands, 9714CA