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
- Are there results?
- None posted in the registry
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).
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Language, Speech and Motor Function in Mild Cognitive Impairment Due to AD and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06508268
- Acronym / sponsor ID
- NL79836.042.23
- Conditions
- Alzheimer's Disease, MCI Due to AD, Dementia Alzheimers
- Keywords
- Alzheimer's disease, MCI due to AD, Language, Speech, Motor, Gait, Hand grip strength, Fluency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 208 participants (estimated)
- Lead sponsor
- Hanze University of Applied Sciences GroningenUniversity, hospital or other
- Collaborators
- University of Groningen
- Study start
- 12 Jul 2024 (estimated)
- Primary completion
- 9 Feb 2025 (estimated)
- Study completion
- 9 Feb 2025 (estimated)
- First posted
- 18 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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..
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Persons with Mild Cognitive Impairment due to AD | – | 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 | – | 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 | – | 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 | – | 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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
Key inclusion criteria (13 listed)
- 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).
- 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).
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GAITRite walkway system OR 4-meter walking speed testGait will be assessed by the GAITRite walkway system OR the 4-meter walking speed test | Behavioural | 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 |
| Jamar hand dynamometerHand grip strength will be assessed by a Jamar hand dynamometer | Behavioural | 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 |
| Picture description taskAlso: Cookie Theft PictureCharacteristics Dutch/Frisian language Language and speech will be assessed by the Cookie Theft Picture-task (a picture description task from Berube et al., 2019) | Behavioural | 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 |
| Autobiographical semi-structured conversationCharacteristics Dutch/Frisian language and speech will be assessed by an autobiographical semi-structured conversation | Behavioural | 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 |
| Verbal fluencyThe mental lexicon of Dutch/Frisian language will be assessed by a two verbal fluency tests, including letter fluency and categorical fluency | Behavioural | 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 |
Primary outcome
Language and speech characteristics of spontaneous speech
Time frame: 4 months
Autobiographical semi-structured interview and a picture description task ("The Cookie Theft Picture (Berube et al., 2019))
Verbal fluency
Time frame: 4 months
Naming animals and professions
Letter fluency
Time frame: 4 months
Naming letters starting with the letters D and A
Temporal and spatial parameters of gait
Time frame: 4 months
Gaitrite walkway system (GAITRite) or 4-meter walking speed test
Hand grip strength
Time frame: 4 months
Jamar hand dynamometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2024.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marlies Oegema, Master (0031+0505953730, m.oegema@pl.hanze.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language and speech characteristics of spontaneous speech (time frame: 4 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2024.