Alzheimer DiseaseRHAPSODYNCT04939818
Clinical Feasibility of Speech Phenotyping for Remote Assessment of Neurodegenerative and Psychiatric Disorders
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Novoic Limited at 2 sites in United Kingdom.
Trial summary
The primary objective of the study is to evaluate the feasibility of eliciting continuous narrative speech in different neurodegenerative and psychiatric indications, using remote, self-administered speech tasks, as measured by the average length of speech elicitation for each speech task during the first week of… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Dementia With Lewy Bodies
- How many people
- 172 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 14 Jun 2021to 15 Sep 2022
- How long will I take part?
- 1 Month
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study population is UK-based.
Who may be able to join
- Willing to participate, having been provided full information about the study components and details.
- Native language is English.
- Has the capacity to provide fully informed consent.
- Has access to and able to use, or has a caregiver who has access to and able to use a smartphone device running an operation system of iOS 11.0 or later, or Android 7.0 or later.
- Able to use, or has a caregiver who is able to use a personal computer, notebook or tablet.
- Has access to a personal computer, notebook or tablet that is (1) Running an operating system of:
- macOS X with macOS 10.9 or later; OR Windows 7 or above; AND (2) Capable of audio recording; AND (3) Able to connect to the internet; AND (4) Have access to one of following internet browser software: Internet Explorer version 11 or above; OR Microsoft Edge version 12 or above; OR Firefox version 27 or above; OR Google Chrome version 30 or above; OR Safari version 7 or above.
Who cannot join
- Diagnosis of alcohol or drug use disorder;
- History or presence of stroke within the past 2 years;
- Documented history of transient ischemic attack or unexplained loss of consciousness within the last 12 months.
- At risk of suicide: score of 10 or above on the PHQ scale, and 10 or above on the MINI suicide questionnaire
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
South London and Maudsley NHS Foundation Trust
London, Greater London, SE5 8AZ
King's College Hospital NHS Foundation Trust
London, Greater London, SE5 9RS
About this study
Official title: A Study to Investigate the Feasibility of Administration of a Speech Battery and the Use of Speech-based Biomarkers for the Clinical Assessment of Common Neurodegenerative and Psychiatric Disorders in a Remote Setting.
The primary objective of the study is to evaluate the feasibility of eliciting continuous narrative speech in different neurodegenerative and psychiatric indications, using remote, self-administered speech tasks, as measured by the average length of speech elicitation for each speech task during the first week of self-assessment. Secondary objectives include (1) evaluating the reliability of speech tasks in the remote self-administered setting, as measured by the intra- and inter-subject variance; (2) accessing the adherence of speech tasks in this setting, as measured by the subject average fraction of days during the first week, where at least one task response is submitted; (3) evaluating the feasibility of using speech tasks in the setting of a telemedicine videoconference, as measured by the average length of speech elicited in each group; (4) evaluate whether a set of acoustic and linguistic patterns can detect each indication, compare to either a control group or all other indications, as measured by the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and Cohen's kappa of the relevant binary classifier; (5) evaluating how the performance of such algorithms can be impacted by speaker and environment covariates, as measured by the Kendall rank correlation coefficient of the AUC of each classifier and each of age group, gender and speech-to-reverberation modulation energy ratio.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia With Lewy Bodies, Dementia, Vascular, Frontotemporal Dementia, Primary Progressive Aphasia
- Keywords
- Speech, Acoustic, Language, Linguistic, Machine Learning, Artificial Intelligence
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Lewy Body Disease, Dementia, Vascular, Frontotemporal Dementia, Aphasia, Primary Progressive, Parkinson Disease, Motor Neuron Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Cognitive Disorders | Alzheimer's Disease (AD) Meet National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria (2011) for MCI due to Alzheimer's or Mild Alzheimer's Dementia Dementia with Lewy bodies (DLB) Diagnosis of possible or probable DLB based on the criteria defined by The Dementia with Lewy Bodies Consortium (2015) Non-AD non-DLB MCI Diagnosis of 'probable' and 'possible' behavioral variant frontotemporal dementia (bvFTD) according to the International Behavioral Variant FTD Criteria Consortium OR semantic variant or nonfluent-agrammatic variant primary progressive aphasia (PPA) FTD according to Mesulam's criteria OR Vascular Dementia according to NINDS-AIREN International Workshop AND Date of diagnosis not more than five years prior to consent Subjects must have MMSE scores of 23-30 (inclusive); or TICS40 score of 20-40 (inclusive) based on a test not older than 1 month at the time of consent. Age of 50-85 years (inclusive) | |
| Group 2: Motor disorders | Parkinson's Disease (PD) * Diagnosis of idiopathic Parkinson's Disease based on the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria * Date of diagnosis not more than five years prior to consent * Hoehn and Yahr stage 2 or less * Age of 30-85 years (inclusive) Motor neuron Disease (MND) * Diagnosis of Amyotrophic Lateral Sclerosis based on gold-standard clinical criteria * Stage 3 or less on the King's ALS Staging system * Age of 18-85 years (inclusive) | |
| Group 3: Affective disorders | Major Depressive Disorder (MDD) * Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a current major depressive episode (MDE) as assessed by the MINI * Current episode of at least moderate severity as assessed by the Clinical Global Impression (CGI) scale. * Date of diagnosis (using MINI assessment) and severity (CGI) maximum of two months prior to consent. * Age of 18-85 years (inclusive). Bipolar Disorder (BD) * Meet DSM-5 criteria for BD as assessed by the MINI (type 1 or type 2) * Current depressive episode as assessed by the MINI * Current episode of at least moderate severity as assessed by the Clinical Global Impression (CGI) scale. * Date of diagnosis (using MINI assessment) and severity (CGI) maximum of two months prior to consent. Age of 18-85 years (inclusive). | |
| Group 4: Unaffected Controls | Group 4 specific recruitment criteria matched for the 'Group 1: Cognitive Disorders' cohort: * Age of 50-85 years (inclusive) * Approximately age, gender and education matched to AD subjects on a group level. * In otherwise good health condition. Group 4 specific recruitment criteria matched for the 'Group 2: Motor Disorders' cohort: * Age of 30-85 years (inclusive) * Approximately age, gender and education matched to PD subjects on a group level. * In otherwise good health condition. Group 4 specific recruitment criteria matched for the 'Group 3: Affective Disorders' cohort: * Age of 30-85 years (inclusive). * Approximately age, gender and education matched to MDD/BD subjects on a group level. * In otherwise good health condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The average length of speech elicitation for each speech task (in seconds) during the first week of self-assessments.
Measured: One week
Secondary outcomes (36)
The intra-subject variance of length of speech elicitation for each speech task during the first week of self-assessments, as measured by Coefficients of Individual Agreement (CIA).
Measured: One week
The inter-subject variance of length of speech elicitation for each speech task during the first week of self-assessments, as measured by Coefficients of Individual Agreement (CIA).
Measured: One week
The subject average fraction of days during the first week of remote, self-assessment, where participants submitted at least one task response.
Measured: One week
The average length of speech elicitation for each speech task, during the telemedicine video conference.
Measured: baseline
The AUC of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.
Measured: One month
The AUC of the binary classifier distinguishing between the Dementia with Lewy Bodies (LBD) diagnostic groups vs the applicable control group.
Measured: One month
The AUC of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.
Measured: One month
The AUC of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.
Measured: One month
The AUC of the binary classifier distinguishing between the Frontotemporal Dementia and Vascular Dementia (FTD/VCI) diagnostic groups vs the applicable control group.
Measured: One month
The AUC of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.
Measured: One month
The AUC of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.
Measured: One month
The sensitivity of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.
Measured: One month
The sensitivity of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.
Measured: One month
The sensitivity of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.
Measured: One month
The sensitivity of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.
Measured: One month
The sensitivity of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.
Measured: One month
The sensitivity of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.
Measured: One month
The sensitivity of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.
Measured: One month
The specificity of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.
Measured: One month
The specificity of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.
Measured: One month
The specificity of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.
Measured: One month
The specificity of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.
Measured: One month
The specificity of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.
Measured: One month
The specificity of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.
Measured: One month
The specificity of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.
Measured: One month
The Cohen's kappa of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.
Measured: One month
The Cohen's kappa of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.
Measured: One month
The Cohen's kappa of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.
Measured: One month
The Cohen's kappa of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.
Measured: One month
The Cohen's kappa of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.
Measured: One month
The Cohen's kappa of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.
Measured: One month
The AUC of the binary classifier distinguishing between the following diagnostic groups vs all other diagnostic groups (pooled): AD, LBD, PD, MND, FTD/VCI, MDD, BD.
Measured: One month
The sensitivity of the binary classifier distinguishing between the following diagnostic groups vs the other groups (pooled): AD, LBD, PD, MND, FTD/VCI, MDD, BD.
Measured: One month
The specificity of the binary classifier distinguishing between the following diagnostic groups vs the other groups (pooled): AD, LBD, PD, MND, FTD/VCI, MDD, BD.
Measured: One month
The Cohen's kappa of the binary classifier distinguishing between the following diagnostic groups vs the other groups (pooled): AD, LBD, PD, MND, FTD/VCI, MDD, BD.
Measured: One month
For each classifier/regressor in the outcomes, the correlation between the AUC/CIA and each age group, gender and speech-to-reverberation modulation energy ratio group, as measured by the Kendall rank correlation coefficient.
Measured: One month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start14 Jun 2021
- Primary completion15 Sep 2022
- Study completion15 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 172 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Novoic Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Allan Young, Professor, Principal investigator, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939818
- Sponsor's protocol ID
- NOV-0200
- Acronym
- RHAPSODY
- Status last verified
- Mar 2023
- First submitted
- 11 Jun 2021
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hampsey E, Meszaros M, Skirrow C, Strawbridge R, Taylor RH, Chok L, Aarsland D, Al-Chalabi A, Chaudhuri R, Weston J, Fristed E, Podlewska A, Awogbemila O, Young AH. Protocol for Rhapsody: a longitudinal observational study examining the feasibility of speech phenotyping for remote assessment of neurodegenerative and psychiatric disorders. BMJ Open. 2022 Jun 6;12(6):e061193. doi: 10.1136/bmjopen-2022-061193.
PubMed 35667724
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Feasibility of Administration of a Speech Battery and the Use of Speech-based Biomarkers for the Clinical Assessment of Common Neurodegenerative and Psychiatric Disorders in a Remote Setting.
- ClinicalTrials.gov ID
- NCT04939818
- Acronym / sponsor ID
- RHAPSODY / NOV-0200
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Dementia With Lewy Bodies, Dementia, Vascular, Frontotemporal Dementia, Primary Progressive Aphasia
- Keywords
- Speech, Acoustic, Language, Linguistic, Machine Learning, Artificial Intelligence
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Novoic LimitedIndustry (pharma, biotech, devices)
- Collaborators
- King's College London
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 15 Sep 2022 (actual)
- Study completion
- 15 Sep 2022 (actual)
- First posted
- 25 Jun 2021 (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 primary objective of the study is to evaluate the feasibility of eliciting continuous narrative speech in different neurodegenerative and psychiatric indications, using remote, self-administered speech tasks, as measured by the average length of speech elicitation for each speech task during the first week of self-assessment. Secondary objectives include (1) evaluating the reliability of speech tasks in the remote self-administered setting, as measured by the intra- and inter-subject variance; (2) accessing the adherence of speech tasks in this setting, as measured by the subject average fraction of days during the first week, where at least one task response is submitted; (3) evaluating the feasibility of using speech tasks in the setting of a telemedicine videoconference, as measured by the average length of speech elicited in each group; (4) evaluate whether a set of acoustic and linguistic patterns can detect each indication, compare to either a control group or all other indications, as measured by the area under the receiver operating characteristic curve (AUC), sensitivity, specificity and Cohen's kappa of the relevant binary classifier; (5) evaluating how the performance of such algorithms can be impacted by speaker and environment covariates, as measured by the Kendall rank correlation coefficient of the AUC of each classifier and each of age group, gender and speech-to-reverberation modulation energy ratio.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Cognitive Disorders | – | –Alzheimer's Disease (AD) Meet National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria (2011) for MCI due to Alzheimer's or Mild Alzheimer's Dementia Dementia with Lewy bodies (DLB) Diagnosis of possible or probable DLB based on the criteria defined by The Dementia with Lewy Bodies Consortium (2015) Non-AD non-DLB MCI Diagnosis of 'probable' and 'possible' behavioral variant frontotemporal dementia (bvFTD) according to the International Behavioral Variant FTD Criteria Consortium OR semantic variant or nonfluent-agrammatic variant primary progressive aphasia (PPA) FTD according to Mesulam's criteria OR Vascular Dementia according to NINDS-AIREN International Workshop AND Date of diagnosis not more than five years prior to consent Subjects must have MMSE scores of 23-30 (inclusive); or TICS40 score of 20-40 (inclusive) based on a test not older than 1 month at the time of consent. Age of 50-85 years (inclusive) |
| Group 2: Motor disorders | – | –Parkinson's Disease (PD) * Diagnosis of idiopathic Parkinson's Disease based on the UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria * Date of diagnosis not more than five years prior to consent * Hoehn and Yahr stage 2 or less * Age of 30-85 years (inclusive) Motor neuron Disease (MND) * Diagnosis of Amyotrophic Lateral Sclerosis based on gold-standard clinical criteria * Stage 3 or less on the King's ALS Staging system * Age of 18-85 years (inclusive) |
| Group 3: Affective disorders | – | –Major Depressive Disorder (MDD) * Meet Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria for a current major depressive episode (MDE) as assessed by the MINI * Current episode of at least moderate severity as assessed by the Clinical Global Impression (CGI) scale. * Date of diagnosis (using MINI assessment) and severity (CGI) maximum of two months prior to consent. * Age of 18-85 years (inclusive). Bipolar Disorder (BD) * Meet DSM-5 criteria for BD as assessed by the MINI (type 1 or type 2) * Current depressive episode as assessed by the MINI * Current episode of at least moderate severity as assessed by the Clinical Global Impression (CGI) scale. * Date of diagnosis (using MINI assessment) and severity (CGI) maximum of two months prior to consent. Age of 18-85 years (inclusive). |
| Group 4: Unaffected Controls | – | –Group 4 specific recruitment criteria matched for the 'Group 1: Cognitive Disorders' cohort: * Age of 50-85 years (inclusive) * Approximately age, gender and education matched to AD subjects on a group level. * In otherwise good health condition. Group 4 specific recruitment criteria matched for the 'Group 2: Motor Disorders' cohort: * Age of 30-85 years (inclusive) * Approximately age, gender and education matched to PD subjects on a group level. * In otherwise good health condition. Group 4 specific recruitment criteria matched for the 'Group 3: Affective Disorders' cohort: * Age of 30-85 years (inclusive). * Approximately age, gender and education matched to MDD/BD subjects on a group level. * In otherwise good health condition. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is UK-based.
Key inclusion criteria (7 listed)
- Willing to participate, having been provided full information about the study components and details.
- Native language is English.
- Has the capacity to provide fully informed consent.
- Has access to and able to use, or has a caregiver who has access to and able to use a smartphone device running an operation system of iOS 11.0 or later, or Android 7.0 or later.
- Able to use, or has a caregiver who is able to use a personal computer, notebook or tablet.
Key exclusion criteria (4 listed)
- Diagnosis of alcohol or drug use disorder;
- History or presence of stroke within the past 2 years;
- Documented history of transient ischemic attack or unexplained loss of consciousness within the last 12 months.
- At risk of suicide: score of 10 or above on the PHQ scale, and 10 or above on the MINI suicide questionnaire
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
The average length of speech elicitation for each speech task (in seconds) during the first week of self-assessments.
Time frame: One week
36 secondary outcomes
The intra-subject variance of length of speech elicitation for each speech task during the first week of self-assessments, as measured by Coefficients of Individual Agreement (CIA).
Time frame: One week
The inter-subject variance of length of speech elicitation for each speech task during the first week of self-assessments, as measured by Coefficients of Individual Agreement (CIA).
Time frame: One week
The subject average fraction of days during the first week of remote, self-assessment, where participants submitted at least one task response.
Time frame: One week
The average length of speech elicitation for each speech task, during the telemedicine video conference.
Time frame: baseline
The AUC of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.
Time frame: One month
The AUC of the binary classifier distinguishing between the Dementia with Lewy Bodies (LBD) diagnostic groups vs the applicable control group.
Time frame: One month
The AUC of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.
Time frame: One month
The AUC of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.
Time frame: One month
The AUC of the binary classifier distinguishing between the Frontotemporal Dementia and Vascular Dementia (FTD/VCI) diagnostic groups vs the applicable control group.
Time frame: One month
The AUC of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.
Time frame: One month
The AUC of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.
Time frame: One month
The sensitivity of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.
Time frame: One month
The sensitivity of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.
Time frame: One month
The sensitivity of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.
Time frame: One month
The sensitivity of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.
Time frame: One month
The sensitivity of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.
Time frame: One month
The sensitivity of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.
Time frame: One month
The sensitivity of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.
Time frame: One month
The specificity of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.
Time frame: One month
The specificity of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.
Time frame: One month
The specificity of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.
Time frame: One month
The specificity of the binary classifier distinguishing between the MND diagnostic groups vs the applicable control group.
Time frame: One month
The specificity of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.
Time frame: One month
The specificity of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.
Time frame: One month
The specificity of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.
Time frame: One month
The Cohen's kappa of the binary classifier distinguishing between the AD diagnostic groups vs the applicable control group.
Time frame: One month
The Cohen's kappa of the binary classifier distinguishing between the LBD diagnostic groups vs the applicable control group.
Time frame: One month
The Cohen's kappa of the binary classifier distinguishing between the PD diagnostic groups vs the applicable control group.
Time frame: One month
The Cohen's kappa of the binary classifier distinguishing between the FTD/VCI diagnostic groups vs the applicable control group.
Time frame: One month
The Cohen's kappa of the binary classifier distinguishing between the MDD diagnostic groups vs the applicable control group.
Time frame: One month
The Cohen's kappa of the binary classifier distinguishing between the BD diagnostic groups vs the applicable control group.
Time frame: One month
The AUC of the binary classifier distinguishing between the following diagnostic groups vs all other diagnostic groups (pooled): AD, LBD, PD, MND, FTD/VCI, MDD, BD.
Time frame: One month
The sensitivity of the binary classifier distinguishing between the following diagnostic groups vs the other groups (pooled): AD, LBD, PD, MND, FTD/VCI, MDD, BD.
Time frame: One month
The specificity of the binary classifier distinguishing between the following diagnostic groups vs the other groups (pooled): AD, LBD, PD, MND, FTD/VCI, MDD, BD.
Time frame: One month
The Cohen's kappa of the binary classifier distinguishing between the following diagnostic groups vs the other groups (pooled): AD, LBD, PD, MND, FTD/VCI, MDD, BD.
Time frame: One month
For each classifier/regressor in the outcomes, the correlation between the AUC/CIA and each age group, gender and speech-to-reverberation modulation energy ratio group, as measured by the Kendall rank correlation coefficient.
Time frame: One month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2023.
- Derived from this study: PubMed 35667724Hampsey E, Meszaros M, Skirrow C, Strawbridge R, Taylor RH, Chok L, Aarsland D, Al-Chalabi A, Chaudhuri R, Weston J, Fristed E, Podlewska A, Awogbemila O, Young AH. Protocol for Rhapsody: a longitudinal observational study examining the feasibility of speech phenotyping for remote assessment of neurodegenerative and psychiatric disorders. BMJ Open. 2022 Jun 6;12(6):e061193. doi: 10.1136/bmjopen-2022-061193.
- Individual participant dataSharing planned: Undecided
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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.
Allan Young, Professor principal investigator
King's College London
2 sites 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 Novoic Limited at 2 sites in United Kingdom.
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 7 inclusion and 4 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: finished, as of the sponsor's last update on 22 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The average length of speech elicitation for each speech task (in seconds) during the first week of self-assessments. (time frame: One week). 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 NCT04939818, which also lists 1 linked publication.
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 Mar 2023.