NCT05732519

Brief Summary

The aim of this observational study is to define speech alterations in the diagnosis of AD-related minor neurocognitive disorder (m-NBB) and major neurocognitive disorder (M-NBB). It is the development of a speech analysis method that can be used in future studies or routine clinical evaluations in these patients by using artificial intelligence and speech recognition methods that are planned to be developed based on the findings obtained. Purposes of the research

  1. 1.To define language disorders in the diagnosis of AD-related minor neurocognitive disorder (m-NBB) and major neurocognitive disorder (M-NBB).
  2. 2.Developing a speech analysis method that can be used in the early diagnosis of neurocognitive disorder patients by using artificial intelligence and speech recognition methods, which are planned to be developed based on the findings.
  3. 3.Evaluation of whether speech analysis distinguishes patients with m-NBB and M-NBB due to AD
  4. 4.Evaluation of whether speech analysis distinguishes minor NBD patients from healthy elderly patients.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not 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

January 30, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

February 17, 2023

Completed
12 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 16, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 16, 2025

Completed
Last Updated

May 3, 2024

Status Verified

May 1, 2024

Enrollment Period

1.8 years

First QC Date

January 30, 2023

Last Update Submit

May 1, 2024

Conditions

Keywords

Speech recognitionAlzheimer diseaseMild cognitive impairmentNeurocognitive disorderlinguistics

Outcome Measures

Primary Outcomes (1)

  • Reaching the sufficient number of participants (120 patients and 60 healthy controls, 180 volunteers in total) and comparing the speech/language functions of the two patient groups with the healthy control group

    about a year

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

\- Patients aged 60 and over followed up with the diagnosis of Minor Neurocognitive Disorder due to AD/ formerly Mild Cognitive Impairment (MCI) and major neurocognitive disorder due to mild or moderate AD according to DSM-5 and healthy elderly volunteers will be included to study.

You may qualify if:

  • Healthy elderly volunteers will be invited to the study by advertisement, who do not have any neurological or psychiatric disorders, who do not use drugs, substances or alcohol that may affect cognitive functions, who do not have sensory defects that prevent the application of the tests, who have an SMMT score of 25 and above, who are 60 years of age and older will be included.
  • For all three groups, the criterion of having received at least 5 years of education will be sought.

You may not qualify if:

  • Presence of additional neurological or psychiatric disease in patient groups, and sensory deficits that prevent the application of tests.
  • Patients with advanced AD diagnosis will not be included in the study.
  • In addition, patients with a HAM-D score above 7 will be excluded from the study, since depression is thought to affect neuropsychological test performances.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara university Faculty of medicine

Ankara, Cankaya, 06000, Turkey (Türkiye)

Location

Related Publications (4)

  • De Looze C, Dehsarvi A, Crosby L, Vourdanou A, Coen RF, Lawlor BA, Reilly RB. Cognitive and Structural Correlates of Conversational Speech Timing in Mild Cognitive Impairment and Mild-to-Moderate Alzheimer's Disease: Relevance for Early Detection Approaches. Front Aging Neurosci. 2021 Apr 27;13:637404. doi: 10.3389/fnagi.2021.637404. eCollection 2021.

    PMID: 33986656BACKGROUND
  • Fraser KC, Meltzer JA, Rudzicz F. Linguistic Features Identify Alzheimer's Disease in Narrative Speech. J Alzheimers Dis. 2016;49(2):407-22. doi: 10.3233/JAD-150520.

    PMID: 26484921BACKGROUND
  • Gosztolya, G., Balogh, R., Imre, N., Egas-Lopez, J. V., Hoffmann, I., Vincze, V., ... & Kálmán, J. (2021). Cross-lingual detection of mild cognitive impairment based on temporal parameters of spontaneous speech. Computer Speech & Language, 69, 101215.

    BACKGROUND
  • Mueller KD, Van Hulle CA, Koscik RL, Jonaitis E, Peters CC, Betthauser TJ, Christian B, Chin N, Hermann BP, Johnson S. Amyloid beta associations with connected speech in cognitively unimpaired adults. Alzheimers Dement (Amst). 2021 May 27;13(1):e12203. doi: 10.1002/dad2.12203. eCollection 2021.

    PMID: 34095435BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseCognitive DysfunctionNeurocognitive Disorders

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesMental DisordersCognition Disorders

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

January 30, 2023

First Posted

February 17, 2023

Study Start

March 1, 2023

Primary Completion

December 16, 2024

Study Completion

December 16, 2025

Last Updated

May 3, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations