Cognitive ImpairmentAMYWEBNCT05298501
Assessing Performance on Speech Tasks Via Crowdsourced Participants
An observational study of Cognitive Impairment and Mild Cognitive Impairment, run by Novoic Limited at 1 site in United Kingdom.
Trial summary
The purpose of the study is to examine the properties of the Automatic Story Recall Test (ASRT) and its parallel variants, as well as letter fluency and category fluency cognitive tests. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cognitive Impairment, Mild Cognitive Impairment
- How many people
- 1,034 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 5 Apr 2022to 8 Jul 2022
- 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 years and older
- All sexes
- Adult, Older adult
Study population: Participants will be recruited online, primarily through crowdsourcing websites.
Who may be able to join
- First language must be English
- Residing in the USA
- Willing to participate in a study investigating speech and dementia
- Able to provide informed consent
- Access to personal computing device that is capable of audio and video recording, and able to connect to the internet
- Since key research questions are focused primarily on older-age speech and cognition, initial recruitment will be focused on older adult age brackets, which may be extended to younger adulthood if the desired sample sizes are not attained.
Who cannot join
- No formal exclusion criteria will apply at the point of recruitment and testing. however, participants with a reported history of neurological conditions or head injury, and current depression will be excluded from normative data development.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: AMYWEB Validation Studies: Assessing Performance on Speech Tasks Via Crowdsourced Participants
The purpose of the study is to examine the properties of the Automatic Story Recall Test (ASRT) and its parallel variants, as well as letter fluency and category fluency cognitive tests. Tests will be completed in crowdsourced populations, to derive normative data, and examine test properties in demographically diverse and cognitively impaired participants recruited and tested online.
Read the detailed description
The AMYWEB study will validate speech tasks developed by NOVOIC in different population samples, including normative samples, samples recruited for enhanced demographic diversity, and participants with reported cognitive impairment.
Participants will be research volunteers recruited online and via crowdsourcing platforms. Six rounds of recruitment will be completed, evaluating different parallel variants of the Automatic Story Recall Task (ASRT), and fluency tasks. During each recruitment round participants will complete a speech test battery and questionnaires during one assessment (Baseline). Speech tasks will be recorded and later analyzed on Novoic's technology platform. All assessments will be fully online and remote.
- Conditions
- Cognitive Impairment, Mild Cognitive Impairment
- Being tested
- No intervention/exposure
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No intervention/exposureOther
No interventions/exposures will be administered or evaluated
| Study group | Role | What they receive |
|---|---|---|
| AMYWEB-Normative | This cohort assessed over six recruitment and test phases, will be sampled to be as closely representative of the demographic population as possible. Receives: Other: No intervention/exposure | |
| AMYWEB-Diversity | This cohort assessed over two recruitment and test phases will oversample participants from minority and mixed ethnic and racial backgrounds as well as participants from lower educational backgrounds. Receives: Other: No intervention/exposure | |
| AMYWEB-MCI | This cohort assessed and recruited over one test phase, will include participants with a reported diagnosis of mild cognitive impairment or dementia. Receives: Other: No intervention/exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age, sex, and education adjusted normative scores for the Automatic Story Recall Task (ASRT) test variants derived via linear regression analysis.
Participants will complete a story recall task (ASRT), which will be administered in triplets (3x stories) with immediate and delayed recall assessed.
Six different test phases, recruiting different participant samples, will be completed in which six parallel ASRT triplets will be separately evaluated.
Normative data will be generated for each test triplet.
Measured: Baseline
Secondary outcomes (9)
Normative data will be derived for shorter variants of the ASRT test battery derived via linear regression analysis.
Age, sex, and education adjusted normative scores for shorter test batteries established in the same way as the primary outcome for each distinct ASRT story triplet, using data from: 1 immediate recall, 2 immediate recalls, 3 immediate recalls, 3 immediate + 1 delayed recall, 3 immediate + 2 delayed recalls.
Measured: Baseline
Age, sex, and education adjusted normative scores for the category fluency task performance derived via linear regression analysis.
During two of the study phases, participants will complete category fluency tests (participants will be asked to name as many Animals or Vegetables as they can within one minute).
Measured: Baseline
Age, sex, and education adjusted normative scores for the letter fluency task performance derived via linear regression analysis.
During two of the study phases, participants will complete letter fluency tests (participants will be asked to say as many words as they can think of beginning with the letters F or S).
Measured: Baseline
The effect of demographic differences on task performance will be evaluated via linear regression analysis.
The effects of age, sex, education and ethnicity on cognitive outcome measures will be evaluated for all cognitive tasks separately.
Measured: Baseline
Demographic and cultural biases will be examined via group or pairwise comparison of transcription error rate and scoring errors on a simple reading task.
In data from a simple reading task evaluated in phases 1 and 2 of the study, transcription errors and automated scoring metrics will be evaluated alongside key demographic variables to test for cultural and demographic biases in automated transcription and scoring.
Measured: Baseline
Performance differences in parallel ASRT variant tasks will be examined via task-wise comparison.
The distribution of test scores across parallel ASRT variants will be evaluated.
Measured: Baseline
Area under the curve (AUC) of the receiver operating characteristic (ROC) curve of the binary classifier distinguishing between the MCI sample and the normative sample using as input the speech elicited during cognitive tasks.
Case control comparison of task performance between participants with AMYWEB-MCI and the AMYWEB-Normative population
Measured: Baseline
Area under the curve (AUC) of the receiver operating characteristic (ROC) curve of the binary classifier distinguishing between depressed and non-depressed participants using as input the speech elicited during cognitive tasks.
All participants will complete the Participant Health Questionnaire (PHQ-8) self-report measure, alongside cognitive assessment. Participants will be separated into low depressive symptomatology (PHQ-8 scores<10), and high depressive symptomatology (PHQ-8 score>=10) groups.
Measured: Baseline
The agreement between the PHQ-8 and the corresponding regression model predicting depressive symptomatology from speech data elicited during tasks will be evaluated.
All participants will complete the Participant Health Questionnaire (PHQ-8) self-report measure, alongside cognitive assessment.
A continuous predictor of PHQ-8 score from speech data will be derived and covariation with continuous PHQ-8 scores will be evaluated.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start5 Apr 2022
- Primary completion8 Jul 2022
- Study completion8 Jul 2022
Why it stopped: Study stopped after first round of assessments and recruitment completed. Latter rounds were no longer required.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ImpairmentStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 1,034 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novoic Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298501
- Sponsor's protocol ID
- NOV-0300
- Acronym
- AMYWEB
- Status last verified
- Mar 2022
- First submitted
- 17 Mar 2022
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AMYWEB Validation Studies: Assessing Performance on Speech Tasks Via Crowdsourced Participants
- ClinicalTrials.gov ID
- NCT05298501
- Acronym / sponsor ID
- AMYWEB / NOV-0300
- Conditions
- Cognitive Impairment, Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study stopped after first round of assessments and recruitment completed. Latter rounds were no longer required.
- Enrolment
- 1,034 participants (actual)
- Lead sponsor
- Novoic LimitedIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 28 Mar 2022 (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 purpose of the study is to examine the properties of the Automatic Story Recall Test (ASRT) and its parallel variants, as well as letter fluency and category fluency cognitive tests. Tests will be completed in crowdsourced populations, to derive normative data, and examine test properties in demographically diverse and cognitively impaired participants recruited and tested online.
Detailed description
The AMYWEB study will validate speech tasks developed by NOVOIC in different population samples, including normative samples, samples recruited for enhanced demographic diversity, and participants with reported cognitive impairment.
Participants will be research volunteers recruited online and via crowdsourcing platforms. Six rounds of recruitment will be completed, evaluating different parallel variants of the Automatic Story Recall Task (ASRT), and fluency tasks. During each recruitment round participants will complete a speech test battery and questionnaires during one assessment (Baseline). Speech tasks will be recorded and later analyzed on Novoic's technology platform. All assessments will be fully online and remote.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMYWEB-Normative | – | Other: No intervention/exposureThis cohort assessed over six recruitment and test phases, will be sampled to be as closely representative of the demographic population as possible. |
| AMYWEB-Diversity | – | Other: No intervention/exposureThis cohort assessed over two recruitment and test phases will oversample participants from minority and mixed ethnic and racial backgrounds as well as participants from lower educational backgrounds. |
| AMYWEB-MCI | – | Other: No intervention/exposureThis cohort assessed and recruited over one test phase, will include participants with a reported diagnosis of mild cognitive impairment or dementia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited online, primarily through crowdsourcing websites.
Key inclusion criteria (6 listed)
- First language must be English
- Residing in the USA
- Willing to participate in a study investigating speech and dementia
- Able to provide informed consent
- Access to personal computing device that is capable of audio and video recording, and able to connect to the internet
Key exclusion criteria (1 listed)
- No formal exclusion criteria will apply at the point of recruitment and testing. however, participants with a reported history of neurological conditions or head injury, and current depression will be excluded from normative data development.
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 |
|---|---|---|
| No intervention/exposureNo interventions/exposures will be administered or evaluated | Other | AMYWEB-Diversity, AMYWEB-MCI, AMYWEB-Normative |
Primary outcome
Age, sex, and education adjusted normative scores for the Automatic Story Recall Task (ASRT) test variants derived via linear regression analysis.
Time frame: Baseline
Participants will complete a story recall task (ASRT), which will be administered in triplets (3x stories) with immediate and delayed recall assessed. Six different test phases, recruiting different participant samples, will be completed in which six parallel ASRT triplets will be separately evaluated. Normative data will be generated for each test triplet.
9 secondary outcomes
Normative data will be derived for shorter variants of the ASRT test battery derived via linear regression analysis.
Time frame: Baseline
Age, sex, and education adjusted normative scores for the category fluency task performance derived via linear regression analysis.
Time frame: Baseline
Age, sex, and education adjusted normative scores for the letter fluency task performance derived via linear regression analysis.
Time frame: Baseline
The effect of demographic differences on task performance will be evaluated via linear regression analysis.
Time frame: Baseline
Demographic and cultural biases will be examined via group or pairwise comparison of transcription error rate and scoring errors on a simple reading task.
Time frame: Baseline
Performance differences in parallel ASRT variant tasks will be examined via task-wise comparison.
Time frame: Baseline
Area under the curve (AUC) of the receiver operating characteristic (ROC) curve of the binary classifier distinguishing between the MCI sample and the normative sample using as input the speech elicited during cognitive tasks.
Time frame: Baseline
Area under the curve (AUC) of the receiver operating characteristic (ROC) curve of the binary classifier distinguishing between depressed and non-depressed participants using as input the speech elicited during cognitive tasks.
Time frame: Baseline
The agreement between the PHQ-8 and the corresponding regression model predicting depressive symptomatology from speech data elicited during tasks will be evaluated.
Time frame: Baseline
Results and safety
The study was stopped early (reason given: Study stopped after first round of assessments and recruitment completed. Latter rounds were no longer required.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- 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.
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 Cognitive Impairment and Mild Cognitive Impairment, run by Novoic Limited at 1 site 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 6 inclusion and 1 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: stopped early, as of the sponsor's last update on 31 Jan 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 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 was stopped early (reason given: Study stopped after first round of assessments and recruitment completed. Latter rounds were no longer required.). 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?
Age, sex, and education adjusted normative scores for the Automatic Story Recall Task (ASRT) test variants derived via linear regression analysis. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2024.