Health TrialsbyHealthPanel

Language, Speech and Motor Function in MCI Due to AD and Alzheimer's Disease

ConditionsAlzheimer's DiseaseMCI Due to ADDementia Alzheimers
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorHanze University of Applied Sciences Groningen

About this trial

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..

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Hearing loss (with or without hearing aid) that affects communication.

Vision loss (with or without glasses or lenses) that affects communication.

Trial 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

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • GAITRite walkway system OR 4-meter walking speed test

    Behavioral

    Gait will be assessed by the GAITRite walkway system OR the 4-meter walking speed test

  • Jamar hand dynamometer

    Behavioral

    Hand grip strength will be assessed by a Jamar hand dynamometer

  • Picture description task

    Behavioral

    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

    Behavioral

    Characteristics Dutch/Frisian language and speech will be assessed by an autobiographical semi-structured conversation

  • Verbal fluency

    Behavioral

    The mental lexicon of Dutch/Frisian language will be assessed by a two verbal fluency tests, including letter fluency and categorical fluency

Treatment groups

208 Participants
are divided into 4 treatment groups
Group A: Persons with Mild Cognitive Impairment due to AD5 interventions
Group B: Persons with mild AD5 interventions
Group C: Persons with moderate AD5 interventions
Group D: Persons without cognitive impairment, age-matched with persons with MCI due to AD and AD5 interventions

Trial outcomes

Primary outcomes

1

Language and speech characteristics of spontaneous speech

Autobiographical semi-structured interview and a picture description task ("The Cookie Theft Picture (Berube et al., 2019))

Time frame
4 months
2

Verbal fluency

Naming animals and professions

Time frame
4 months
3

Letter fluency

Naming letters starting with the letters D and A

Time frame
4 months
4

Temporal and spatial parameters of gait

Gaitrite walkway system (GAITRite) or 4-meter walking speed test

Time frame
4 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hanze University of Applied Sciences Groningen

Lead sponsor

University of Groningen

Collaborator

Source ClinicalTrials.gov
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