Alzheimer's DiseaseNCT06508268
Language, Speech and Motor Function in MCI Due to AD and Alzheimer's Disease
An observational study of Alzheimer's Disease and MCI Due to AD, run by Hanze University of Applied Sciences Groningen at 1 site in Netherlands.
Trial 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 ("MCI due to AD") and persons with mild and moderate Alzheimer's disease ("AD"). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, MCI Due to AD, Dementia Alzheimers
- What is being tested?
- GAITRite walkway system OR 4-meter walking speed test, Jamar hand dynamometer and Picture description task
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 208 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 Jul 2024to 9 Feb 2025
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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:
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- 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).
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Hanze University
Groningen, 9714CA
Oegema Marlies, Master, 0031505953730, m.oegema@pl.hanze.nl
About this study
Official title: Language, Speech and Motor Function in Mild Cognitive Impairment Due to AD and Alzheimer's Disease
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:
- 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.
Read more
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..
- Conditions
- Alzheimer's Disease, MCI Due to AD, Dementia Alzheimers
- Being tested
- GAITRite walkway system OR 4-meter walking speed test, Jamar hand dynamometer, Picture description task, Autobiographical semi-structured conversation, Verbal fluency
- Keywords
- Alzheimer's disease, MCI due to AD, Language, Speech, Motor, Gait, Hand grip strength, Fluency
- Medical subject headings
- Alzheimer Disease, Language, Speech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GAITRite walkway system OR 4-meter walking speed testBehavioural
Gait will be assessed by the GAITRite walkway system OR the 4-meter walking speed test
Jamar hand dynamometerBehavioural
Hand grip strength will be assessed by a Jamar hand dynamometer
Picture description taskBehavioural
Also called Cookie Theft Picture
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 conversationBehavioural
Characteristics Dutch/Frisian language and speech will be assessed by an autobiographical semi-structured conversation
Verbal fluencyBehavioural
The mental lexicon of Dutch/Frisian language will be assessed by a two verbal fluency tests, including letter fluency and categorical fluency
| Study group | Role | What they receive |
|---|---|---|
| Persons with Mild Cognitive Impairment due to AD | Not described Receives: 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 | |
| Persons with mild AD | Not described Receives: 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 | |
| Persons with moderate AD | Not described Receives: 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 | |
| Persons without cognitive impairment, age-matched with persons with MCI due to AD and AD | Not described Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language and speech characteristics of spontaneous speech
Autobiographical semi-structured interview and a picture description task ("The Cookie Theft Picture (Berube et al., 2019))
Measured: 4 months
Verbal fluency
Naming animals and professions
Measured: 4 months
Letter fluency
Naming letters starting with the letters D and A
Measured: 4 months
Temporal and spatial parameters of gait
Gaitrite walkway system (GAITRite) or 4-meter walking speed test
Measured: 4 months
Hand grip strength
Jamar hand dynamometer
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2024
- Study start12 Jul 2024 (estimated)
- Primary completion9 Feb 2025 (estimated)
- Study completion9 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 208 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanze University of Applied Sciences Groningen
- Sponsor type
- University, hospital or other
- Collaborators
- University of Groningen
- Responsible party
- Principal investigator, Hans Hobbelen, Hanze University of Applied Sciences Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06508268
- Sponsor's protocol ID
- NL79836.042.23
- Status last verified
- Jul 2024
- First submitted
- 22 May 2024
- Last updated
- 18 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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).