Alzheimer DiseaseNCT04041895
Detecting Probable Alzheimer's Disease From Speech Using Linguistical Analysis
An observational study of Alzheimer Disease and Dementia, run by East Tennessee State University at 1 site in United States.
Trial summary
The object of this study is to investigate the use of linguistic deficits from speech samples for the early detection of Mild Cognitive Impairment and probable Alzheimer's disease. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Dementia
- What is being tested?
- Audio speech recording
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to Aug 2020
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants would have undertaken an Amyloid PET scan to confirm the presence or absence of Amyloid plaques in the brain through a previously approved study on Alzheimer's disease with Amyloid PET imaging or at the request of their physician to determine possible cause of suspected cognitive decline.
Who may be able to join
- Participants who have undergone the Mini Mental State Examination (MMSE).
- Participants who have undergone Amyloid PET scan with a diagnosis of having the Amyloid plaques or not.
- Participants with moderate or fluent English speaking ability.
Who cannot join
- Participants who cannot speak as the data collection process needs to obtain speech samples.
- Participants who are severely demented or at a very late stage of Alzheimer's disease.
- Participants with stroke.
- Participants who report a history of other neurodegenerative disorders than MCI and AD.
- Participants with chronic vision impairment or who cannot see with the aid of corrective glasses.
- Participants who cannot speak English.
- A participant who have been diagnosed with HIV/AIDS as this may have a cognitive effect on its own.
Trial locations and contacts
1 site in 1 country.
United States1 site
East Tennessee State University
Johnson City, Tennessee, 37614
About this study
Official title: Detecting Mild Cognitive Impairment and Probable Alzheimer's Disease From Speech Using Linguistic Deficits With Amyloid PET Imaging as a Baseline.
The object of this study is to investigate the use of linguistic deficits from speech samples for the early detection of Mild Cognitive Impairment and probable Alzheimer's disease. It will also evaluate whether the result of the Amyloid PET scan would confirm the effectiveness of a less expensive and less intrusive diagnostic technique through speech
Read the detailed description
This study will investigate the use of linguistic deficits through a computational diagnostic model for the prediction of Mild Cognitive Impairment (MCI) and Probable Alzheimer's disease (PrAD) from speech samples (verbal utterances). The premise is that MCI and PrAD are characterized by the deterioration of nerve cells that control cognitive speech and language processes, which consequently affects how patients compose verbal utterances. As the Amyloid Positron Emission Tomography (PET) scan is making advances in giving confirmatory evidence of the existence of plaques in the brain, there is the opportunity to investigate whether the result of the scan would confirm the effectiveness of a less expensive and less intrusive diagnostic technique. In this study, participants of a previous IRB approved study on Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) who consent to participate in the new study will be requested to perform a basic descriptive task. The main task to be done by the participants is to verbally describe the scenes on a projected image, while their verbal utterances will be recorded via an audio recorder. The descriptive task is expected to take between 10 to 15 minutes on average. Participants will be required to describe the scenes on the projected Cookie-Theft image (http://www.amyspeechlanguagetherapy.com/thecookie- theft-picture.html). The image is part of the Provide a brief but thorough description of the study. What is the study about? This does not need to contain a summary of background literature. It should just summarize the study itself. Boston Diagnostic Aphasia Examination (BDAE-3) and it is adapted in our study for the purpose of capturing the complexity in the linguistic expression similar to the DementiaBank project (https://talkbank.org/media/DementiaBank/Pitt/cookie/). Note that we are NOT conducting any psychological examination using the BDAE-3, we have only referenced the source of the Cookie-Theft image, which is publicly available for research and has been used for decades. An example of the task is demonstrated in this video: https://www.youtube.com/watch?v=1NB8wBBguMg. The transcripts of the recorded interview will be analyzed by our proposed computational model to detect the presence of Mild Cognitive Impairment or probable Alzheimer's disease. Finally, the IDEAS study PET scan data would be used in conjunction with the transcripts of the recorded interview to compare the results of the linguistic analysis of the transcript with those of the PET scan in making Mild Cognitive Impairment or probable Alzheimer's Disease diagnoses.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- Audio speech recording
- Keywords
- Alzheimer's Disease, Dementia, Linguistics
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audio speech recordingOther
Audio recording of speech sample from subject description of Cookie-Theft image.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer's Disease | Those individuals who possess a significant amyloid burden per results of a previous amyloid PET scan radiology report. Receives: Other: Audio speech recording | |
| Control | Those individuals who do not possess a significant amyloid burden per results of a previous amyloid PET scan radiology report. Receives: Other: Audio speech recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of speech audio recording describing the "Cookie-Thief Image" using proposed computational model designed by PI for determination of Alzheimer's disease
Analysis of speech audio recording of participants description of Cookie-Thief Image The image is part of the Provide a brief but thorough description of the study. What is the study about? This does not need to contain a summary of background literature. It should just summarize the study itself. Boston Diagnostic Aphasia Examination (BDAE-3) and it is adapted in our study for the purpose of capturing the complexity in the linguistic expression similar to the DementiaBank project (https://talkbank.org/media/DementiaBank/Pitt/cookie/) using proposed computational model for determination of Alzheimer's disease
Measured: through study completion, an average of 1 year
Secondary outcomes (1)
MMSE
Mini Mental State Examination
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study start13 Aug 2018
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Why it stopped: Unsuccessful in recruiting participants for that study because we needed subjects who had performed Amyloid PET imaging in the last year
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Tennessee State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvester Olubolu Orimaye, East Tennessee State University
- Investigators
- Sylvester O Orimaye, PhD, MPH, Principal investigator, East Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04041895
- Sponsor's protocol ID
- 0218.16sw
- Status last verified
- Nov 2022
- First submitted
- 29 Jul 2019
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Orimaye, S. O., Wong, J. S. M., & Golden, K. J. (2014, June). Learning predictive linguistic features for Alzheimer's disease and related dementias using verbal utterances. In Proceedings of the 1st Workshop on Computational Linguistics and Clinical Psychology (CLPsych) (pp. 78-87). sn.
Orimaye SO, Wong JS, Golden KJ, Wong CP, Soyiri IN. Predicting probable Alzheimer's disease using linguistic deficits and biomarkers. BMC Bioinformatics. 2017 Jan 14;18(1):34. doi: 10.1186/s12859-016-1456-0.
PubMed 28088191Roark B, Mitchell M, Hosom JP, Hollingshead K, Kaye J. Spoken Language Derived Measures for Detecting Mild Cognitive Impairment. IEEE Trans Audio Speech Lang Process. 2011 Sep 1;19(7):2081-2090. doi: 10.1109/TASL.2011.2112351.
PubMed 22199464Fraser KC, Meltzer JA, Graham NL, Leonard C, Hirst G, Black SE, Rochon E. Automated classification of primary progressive aphasia subtypes from narrative speech transcripts. Cortex. 2014 Jun;55:43-60. doi: 10.1016/j.cortex.2012.12.006. Epub 2012 Dec 21.
PubMed 23332818Prud'hommeaux E, Roark B. Graph-Based Word Alignment for Clinical Language Evaluation. Comput Linguist Assoc Comput Linguist. 2015 Dec;41(4):549-578. doi: 10.1162/coli_a_00232. Epub 2015 Dec 1.
PubMed 34334943Verma M, Howard RJ. Semantic memory and language dysfunction in early Alzheimer's disease: a review. Int J Geriatr Psychiatry. 2012 Dec;27(12):1209-17. doi: 10.1002/gps.3766. Epub 2012 Feb 1.
PubMed 22298328Reilly J, Rodriguez AD, Lamy M, Neils-Strunjas J. Cognition, language, and clinical pathological features of non-Alzheimer's dementias: an overview. J Commun Disord. 2010 Sep-Oct;43(5):438-52. doi: 10.1016/j.jcomdis.2010.04.011. Epub 2010 May 6.
PubMed 20493496Klimova B, Maresova P, Valis M, Hort J, Kuca K. Alzheimer's disease and language impairments: social intervention and medical treatment. Clin Interv Aging. 2015 Aug 27;10:1401-7. doi: 10.2147/CIA.S89714. eCollection 2015.
PubMed 26346123Fraser 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 2648492110. Lunsford, R., & Heeman, P. A. (2015, September). Using linguistic indicators of difficulty to identify mild cognitive impairment. In INTERSPEECH (pp. 658-662).
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Mild Cognitive Impairment and Probable Alzheimer's Disease From Speech Using Linguistic Deficits With Amyloid PET Imaging as a Baseline.
- ClinicalTrials.gov ID
- NCT04041895
- Acronym / sponsor ID
- 0218.16sw
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Alzheimer's Disease, Dementia, Linguistics
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unsuccessful in recruiting participants for that study because we needed subjects who had performed Amyloid PET imaging in the last year
- Enrolment
- 0 participants (actual)
- Lead sponsor
- East Tennessee State UniversityUniversity, hospital or other
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 1 Aug 2019 (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 object of this study is to investigate the use of linguistic deficits from speech samples for the early detection of Mild Cognitive Impairment and probable Alzheimer's disease. It will also evaluate whether the result of the Amyloid PET scan would confirm the effectiveness of a less expensive and less intrusive diagnostic technique through speech
Detailed description
This study will investigate the use of linguistic deficits through a computational diagnostic model for the prediction of Mild Cognitive Impairment (MCI) and Probable Alzheimer's disease (PrAD) from speech samples (verbal utterances). The premise is that MCI and PrAD are characterized by the deterioration of nerve cells that control cognitive speech and language processes, which consequently affects how patients compose verbal utterances. As the Amyloid Positron Emission Tomography (PET) scan is making advances in giving confirmatory evidence of the existence of plaques in the brain, there is the opportunity to investigate whether the result of the scan would confirm the effectiveness of a less expensive and less intrusive diagnostic technique. In this study, participants of a previous IRB approved study on Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) who consent to participate in the new study will be requested to perform a basic descriptive task. The main task to be done by the participants is to verbally describe the scenes on a projected image, while their verbal utterances will be recorded via an audio recorder. The descriptive task is expected to take between 10 to 15 minutes on average. Participants will be required to describe the scenes on the projected Cookie-Theft image (http://www.amyspeechlanguagetherapy.com/thecookie- theft-picture.html). The image is part of the Provide a brief but thorough description of the study. What is the study about? This does not need to contain a summary of background literature. It should just summarize the study itself. Boston Diagnostic Aphasia Examination (BDAE-3) and it is adapted in our study for the purpose of capturing the complexity in the linguistic expression similar to the DementiaBank project (https://talkbank.org/media/DementiaBank/Pitt/cookie/). Note that we are NOT conducting any psychological examination using the BDAE-3, we have only referenced the source of the Cookie-Theft image, which is publicly available for research and has been used for decades. An example of the task is demonstrated in this video: https://www.youtube.com/watch?v=1NB8wBBguMg. The transcripts of the recorded interview will be analyzed by our proposed computational model to detect the presence of Mild Cognitive Impairment or probable Alzheimer's disease. Finally, the IDEAS study PET scan data would be used in conjunction with the transcripts of the recorded interview to compare the results of the linguistic analysis of the transcript with those of the PET scan in making Mild Cognitive Impairment or probable Alzheimer's Disease diagnoses.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease | – | Other: Audio speech recordingThose individuals who possess a significant amyloid burden per results of a previous amyloid PET scan radiology report. |
| Control | – | Other: Audio speech recordingThose individuals who do not possess a significant amyloid burden per results of a previous amyloid PET scan radiology report. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants would have undertaken an Amyloid PET scan to confirm the presence or absence of Amyloid plaques in the brain through a previously approved study on Alzheimer's disease with Amyloid PET imaging or at the request of their physician to determine possible cause of suspected cognitive decline.
Key inclusion criteria (3 listed)
- Participants who have undergone the Mini Mental State Examination (MMSE).
- Participants who have undergone Amyloid PET scan with a diagnosis of having the Amyloid plaques or not.
- Participants with moderate or fluent English speaking ability.
Key exclusion criteria (7 listed)
- Participants who cannot speak as the data collection process needs to obtain speech samples.
- Participants who are severely demented or at a very late stage of Alzheimer's disease.
- Participants with stroke.
- Participants who report a history of other neurodegenerative disorders than MCI and AD.
- Participants with chronic vision impairment or who cannot see with the aid of corrective glasses.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audio speech recordingAudio recording of speech sample from subject description of Cookie-Theft image. | Other | Alzheimer's Disease, Control |
Primary outcome
Analysis of speech audio recording describing the "Cookie-Thief Image" using proposed computational model designed by PI for determination of Alzheimer's disease
Time frame: through study completion, an average of 1 year
Analysis of speech audio recording of participants description of Cookie-Thief Image The image is part of the Provide a brief but thorough description of the study. What is the study about? This does not need to contain a summary of background literature. It should just summarize the study itself. Boston Diagnostic Aphasia Examination (BDAE-3) and it is adapted in our study for the purpose of capturing the complexity in the linguistic expression similar to the DementiaBank project (https://talkbank.org/media/DementiaBank/Pitt/cookie/) using proposed computational model for determination of Alzheimer's disease
1 secondary outcome
MMSE
Time frame: through study completion, an average of 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
- BackgroundOrimaye, S. O., Wong, J. S. M., & Golden, K. J. (2014, June). Learning predictive linguistic features for Alzheimer's disease and related dementias using verbal utterances. In Proceedings of the 1st Workshop on Computational Linguistics and Clinical Psychology (CLPsych) (pp. 78-87). sn.
- Background: PubMed 28088191Orimaye SO, Wong JS, Golden KJ, Wong CP, Soyiri IN. Predicting probable Alzheimer's disease using linguistic deficits and biomarkers. BMC Bioinformatics. 2017 Jan 14;18(1):34. doi: 10.1186/s12859-016-1456-0.
- Background: PubMed 22199464Roark B, Mitchell M, Hosom JP, Hollingshead K, Kaye J. Spoken Language Derived Measures for Detecting Mild Cognitive Impairment. IEEE Trans Audio Speech Lang Process. 2011 Sep 1;19(7):2081-2090. doi: 10.1109/TASL.2011.2112351.
- Background: PubMed 23332818Fraser KC, Meltzer JA, Graham NL, Leonard C, Hirst G, Black SE, Rochon E. Automated classification of primary progressive aphasia subtypes from narrative speech transcripts. Cortex. 2014 Jun;55:43-60. doi: 10.1016/j.cortex.2012.12.006. Epub 2012 Dec 21.
- Background: PubMed 34334943Prud'hommeaux E, Roark B. Graph-Based Word Alignment for Clinical Language Evaluation. Comput Linguist Assoc Comput Linguist. 2015 Dec;41(4):549-578. doi: 10.1162/coli_a_00232. Epub 2015 Dec 1.
- Background: PubMed 22298328Verma M, Howard RJ. Semantic memory and language dysfunction in early Alzheimer's disease: a review. Int J Geriatr Psychiatry. 2012 Dec;27(12):1209-17. doi: 10.1002/gps.3766. Epub 2012 Feb 1.
- Background: PubMed 20493496Reilly J, Rodriguez AD, Lamy M, Neils-Strunjas J. Cognition, language, and clinical pathological features of non-Alzheimer's dementias: an overview. J Commun Disord. 2010 Sep-Oct;43(5):438-52. doi: 10.1016/j.jcomdis.2010.04.011. Epub 2010 May 6.
- Background: PubMed 26346123Klimova B, Maresova P, Valis M, Hort J, Kuca K. Alzheimer's disease and language impairments: social intervention and medical treatment. Clin Interv Aging. 2015 Aug 27;10:1401-7. doi: 10.2147/CIA.S89714. eCollection 2015.
- 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.
- Background10. Lunsford, R., & Heeman, P. A. (2015, September). Using linguistic indicators of difficulty to identify mild cognitive impairment. In INTERSPEECH (pp. 658-662).
- 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.
Sylvester O Orimaye, PhD, MPH principal investigator
East Tennessee State University
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 Dementia, run by East Tennessee State University at 1 site in United States.
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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 22 Nov 2022. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Analysis of speech audio recording describing the "Cookie-Thief Image" using proposed computational model designed by PI for determination of Alzheimer's disease (time frame: through study completion, an average of 1 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 NCT04041895, which also lists 10 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 22 Nov 2022.