Alzheimer DiseaseTurkSpeechNCT05732519
Turkish Speech Analysis Development Study
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by mihrimah ozturk at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- How many people
- 180 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 16 Dec 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara university Faculty of medicine
Ankara, Cankaya, 06000
About this study
Official title: Turkish Speech Analysis Development Study for Major Neurocognitive Disorder Due to Alzheimer's Disease
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
Read more
- To define language disorders in the diagnosis of AD-related minor neurocognitive disorder (m-NBB) and major neurocognitive disorder (M-NBB).
- 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.
- Evaluation of whether speech analysis distinguishes patients with m-NBB and M-NBB due to AD
- 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.
Read the detailed description
The diagnosis of Alzheimer's Disease (AD) is based on clinical criteria using neuropsychological tests and neuroimaging, and is currently a diagnosis of exclusion and neuropathological examination/autopsy is required for a definitive diagnosis. Biomarkers, which have been tried to be developed recently, have not gained enough place in clinical use because they are considered to be high cost and/or risky.In recent years, the use of features of speech signals and spontaneous speech in the detection of AD has yielded successful results. It is thought that advances in classification, sound processing and speech recognition will facilitate disease diagnosis.
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
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Speech recognition, Alzheimer disease, Mild cognitive impairment, Neurocognitive disorder, linguistics
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Neurocognitive Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: about a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2023
- Study start1 Mar 2023
- Primary completion16 Dec 2024 (estimated)
- Study completion16 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer 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
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- mihrimah ozturk
- Sponsor type
- University, hospital or other
- Collaborators
- Ankara University
- Responsible party
- Sponsor-investigator, mihrimah ozturk, Kırıkkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05732519
- Sponsor's protocol ID
- AlzheimerSpeech
- Acronym
- TurkSpeech
- Status last verified
- May 2024
- First submitted
- 30 Jan 2023
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33986656Fraser 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.
PubMed 26484921Gosztolya, 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.
PubMed 34095435
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Speech Analysis Development Study for Major Neurocognitive Disorder Due to Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05732519
- Acronym / sponsor ID
- TurkSpeech / AlzheimerSpeech
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Speech recognition, Alzheimer disease, Mild cognitive impairment, Neurocognitive disorder, linguistics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (actual)
- Lead sponsor
- mihrimah ozturkUniversity, hospital or other
- Collaborators
- Ankara University
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 16 Dec 2024 (estimated)
- Study completion
- 16 Dec 2025 (estimated)
- First posted
- 17 Feb 2023 (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 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
- To define language disorders in the diagnosis of AD-related minor neurocognitive disorder (m-NBB) and major neurocognitive disorder (M-NBB).
- 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.
- Evaluation of whether speech analysis distinguishes patients with m-NBB and M-NBB due to AD
- 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.
Detailed description
The diagnosis of Alzheimer's Disease (AD) is based on clinical criteria using neuropsychological tests and neuroimaging, and is currently a diagnosis of exclusion and neuropathological examination/autopsy is required for a definitive diagnosis. Biomarkers, which have been tried to be developed recently, have not gained enough place in clinical use because they are considered to be high cost and/or risky.In recent years, the use of features of speech signals and spontaneous speech in the detection of AD has yielded successful results. It is thought that advances in classification, sound processing and speech recognition will facilitate disease diagnosis.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: about a year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Background: PubMed 33986656De 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.
- Background: PubMed 26484921Fraser 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.
- BackgroundGosztolya, 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: PubMed 34095435Mueller 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.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Disease and Mild Cognitive Impairment, run by mihrimah ozturk at 1 site in Turkey (Türkiye).
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 2 inclusion and 3 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 3 May 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 Turkey (Türkiye). 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: about a year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05732519, which also lists 4 linked publications.
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 3 May 2024.