NCT06508268

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 ("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..

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
208

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

July 12, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 9, 2025

Completed
Last Updated

July 18, 2024

Status Verified

July 1, 2024

Enrollment Period

7 months

First QC Date

May 22, 2024

Last Update Submit

July 17, 2024

Conditions

Alzheimer's DiseaseMCI Due to ADDementia Alzheimers

Keywords

Alzheimer's diseaseMCI due to ADLanguageSpeechMotorGaitHand grip strengthFluency

Outcome Measures

Primary Outcomes (5)

  • Language and speech characteristics of spontaneous speech

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

    4 months

  • Verbal fluency

    Naming animals and professions

    4 months

  • Letter fluency

    Naming letters starting with the letters D and A

    4 months

  • Temporal and spatial parameters of gait

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

    4 months

  • Hand grip strength

    Jamar hand dynamometer

    4 months

Study Arms (4)

Persons with Mild Cognitive Impairment due to AD

Behavioral: GAITRite walkway system OR 4-meter walking speed testBehavioral: Jamar hand dynamometerBehavioral: Picture description taskBehavioral: Autobiographical semi-structured conversationBehavioral: Verbal fluency

Persons with mild AD

Behavioral: GAITRite walkway system OR 4-meter walking speed testBehavioral: Jamar hand dynamometerBehavioral: Picture description taskBehavioral: Autobiographical semi-structured conversationBehavioral: Verbal fluency

Persons with moderate AD

Behavioral: GAITRite walkway system OR 4-meter walking speed testBehavioral: Jamar hand dynamometerBehavioral: Picture description taskBehavioral: Autobiographical semi-structured conversationBehavioral: 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 testBehavioral: Jamar hand dynamometerBehavioral: Picture description taskBehavioral: Autobiographical semi-structured conversationBehavioral: Verbal fluency

Interventions

GAITRite walkway system OR 4-meter walking speed testBEHAVIORAL

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

Persons with Mild Cognitive Impairment due to ADPersons with mild ADPersons with moderate ADPersons without cognitive impairment, age-matched with persons with MCI due to AD and AD
Jamar hand dynamometerBEHAVIORAL

Hand grip strength will be assessed by a Jamar hand dynamometer

Persons with Mild Cognitive Impairment due to ADPersons with mild ADPersons with moderate ADPersons without cognitive impairment, age-matched with persons with MCI due to AD and AD
Picture description taskBEHAVIORAL

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)

Also known as: Cookie Theft Picture
Persons with Mild Cognitive Impairment due to ADPersons with mild ADPersons with moderate ADPersons without cognitive impairment, age-matched with persons with MCI due to AD and AD
Autobiographical semi-structured conversationBEHAVIORAL

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

Persons with Mild Cognitive Impairment due to ADPersons with mild ADPersons with moderate ADPersons without cognitive impairment, age-matched with persons with MCI due to AD and AD
Verbal fluencyBEHAVIORAL

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

Persons with Mild Cognitive Impairment due to ADPersons with mild ADPersons with moderate ADPersons without cognitive impairment, age-matched with persons with MCI due to AD and AD

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanze University

Groningen, 9714CA, Netherlands

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseLanguageSpeech

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCommunicationBehaviorVerbal Behavior

Central Study Contacts

Marlies Oegema, Master

CONTACT

0031+0505953730m.oegema@pl.hanze.nl

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

May 22, 2024

First Posted

July 18, 2024

Study Start

July 12, 2024

Primary Completion

February 9, 2025

Study Completion

February 9, 2025

Last Updated

July 18, 2024

Record last verified: 2024-07

Locations

NL(1)