Exploring language, speech, and motor function in Alzheimer's disease and mild cognitive impairment
Language, Speech and Motor Function in Mild Cognitive Impairment Due to AD and Alzheimer's Disease
This study is trying to see how language, speech, and movement change in people with mild cognitive impairment or Alzheimer's disease compared to those without any cognitive issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 208 (estimated) |
| Sex | All |
| Sponsor | Hanze University of Applied Sciences Groningen Academic / other |
| Locations | 1 site (Groningen) |
| Trial ID | NCT06508268 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the characteristics of language, speech, and motor function in individuals with Mild Cognitive Impairment due to Alzheimer's disease (MCI due to AD) and those with mild to moderate Alzheimer's disease (AD). Participants will undergo various tests to assess their motor skills, speech, and language abilities, and results will be compared to an age-matched control group without cognitive impairment. The study seeks to provide insights into how these functions change in relation to cognitive decline associated with Alzheimer's disease.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed with MCI due to Alzheimer's disease or mild to moderate Alzheimer's disease, as well as age-matched controls without cognitive impairment.
Not a fit: Patients with severe Alzheimer's disease or those without any cognitive impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of the interplay between cognitive decline and motor, speech, and language functions, potentially leading to improved diagnostic and therapeutic strategies for Alzheimer's disease.
How similar studies have performed: While there have been studies exploring cognitive functions in Alzheimer's disease, this specific combination of language, speech, and motor function assessment in MCI due to AD is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Criteria: 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).
Where this trial is running
Groningen
- Hanze University — Groningen, Netherlands (Recruiting)
Study contacts
- Study coordinator: Marlies Oegema, Master
- Email: m.oegema@pl.hanze.nl
- Phone: 0031+0505953730
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.