Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
180 participants
OBSERVATIONAL
2023-03-01
2025-12-16
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Purposes of the research
1. To define language disorders in the diagnosis of AD-related minor neurocognitive disorder (m-NBB) and major neurocognitive disorder (M-NBB).
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. Evaluation of whether speech analysis distinguishes patients with m-NBB and M-NBB due to AD
4. Evaluation of whether speech analysis distinguishes minor NBD patients from healthy elderly patients.
Standardized Mini-Mental Test, Clock Drawing Test, Montreal Cognitive Assessment Scale, Rey Auditory Verbal Learning Test, Verbal Fluency Test, Enhanced Cued Recall Test, Functional Activities Questionnaire, Trail Making Test, and Hamilton Depression Scale to evaluate the severity of depressive symptoms will be administered to the participants to assess cognitive functions. . In order to evaluate speech the Cookie Theft Picture Description Test, which is a part of the Boston Aphasia Test, will be administered to the participants.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Semantic Recognition Task (SRT) in Alzheimer Disease
NCT05711888
Association of Cognition With Functional Mobility in People With Alzheimer's Disease
NCT05113732
Cognitive Stimulation Therapy for Dementia
NCT05514678
Education of Caregivers of Alzheimer's Patients
NCT06182930
Cortical Disarray Measurement in Mild Cognitive Impairment and Alzheimer's Disease
NCT05579236
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
It is thought that new researches should be made in Turkish based on literature data, since the Turkish language structure is agglutinative, some words such as the verb 'to be' do not have Turkish equivalents, the sentence order is in the form of subject/object/predicate, and personal pronouns are used less frequently than in English.
In this respect, it is thought that the planned study will make an important contribution to the field in terms of being the first study to make a comprehensive assessment of language problems in patients with AD and Mild Cognitive Impairment and to use artificial intelligence methods. To the best of our knowledge, as there is currently no speech-based corpus for the assessment of progression from healthy aging to AD, one of the important contributions of the data to be obtained from this study is that produced by healthy elderly, amnestic type minor neurocognitive disorder and patients with major neurocognitive disorder due to AD. It may be the basis for the creation of a corpus of standard speech samples.
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. 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. Exclusion criteria will also be the presence of additional neurological or psychiatric disease in patient groups, and sensory deficits that prevent the application of tests. For all three groups, the criterion of having received at least 5 years of education will be sought. 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.
The sample size was calculated by evaluating the results of studies conducted with similar methods in the literature, and the effect size was accepted as 0.25 with the G\*Power3.1 program, and the sample size was calculated with a 95% confidence interval, 80% power and 5% margin of error. As a result of the analysis, the total sample size was calculated as 159; A total of 180 participants (120 patients, 60 healthy controls) were planned to be included in the study, including 60 m-NBB, 60 M-NBB due to AD, and 60 healthy controls.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
CROSS_SECTIONAL
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* For all three groups, the criterion of having received at least 5 years of education will be sought.
Exclusion Criteria
* 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.
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Ankara University
OTHER
mihrimah ozturk
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
mihrimah ozturk
Assistant professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ankara university Faculty of medicine
Ankara, Cankaya, Turkey (Türkiye)
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AlzheimerSpeech
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.