Alzheimer DiseaseAMYPRED-FUTURENCT04846426
Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech - FUTURE Extension
An observational study of Alzheimer Disease and Preclinical Alzheimer's Disease, run by Novoic Limited at 4 sites in United Kingdom.
Trial summary
The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech, can predict change in PACC5 between baseline and +12 month follow up across all four Arms, as measured by the coefficient of individual agreement (CIA) between the change in PACC5 and the… Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease
- How many people
- 67 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 19 Nov 2020to 7 Jun 2024
- How long will I take part?
- 3 Years
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants will be identified from participants of the AMYPRED study.
Who may be able to join
- Subjects are fully eligible for and have completed the AMYPRED (Amyloid Prediction in early stage Alzheimer's disease from acoustic and linguistic patterns of speech) study.
- (See https://clinicaltrials.gov/ct2/show/NCT04828122)
- Subject consents to take part in FUTURE extension study.
Who cannot join
- Subject hasn't completed the full visit day in the AMYPRED study.
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites
Re:Cognition Health
Birmingham, B16 8LT
Re:Cognition Health
Guildford, GU2 7YD
Re:Cognition Health
London, W1G9JF
Re:Cognition Health
Plymouth, PL68BT
About this study
Official title: A Study to Evaluate the Ability of Speech- and Language-based Digital Biomarkers to Detect and Characterise Prodromal and Preclinical Alzheimer's Disease in a Clinical Setting - FUTURE Extension Study.
The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech, can predict change in PACC5 between baseline and +12 month follow up across all four Arms, as measured by the coefficient of individual agreement (CIA) between the change in PACC5 and the corresponding regression model, trained on baseline speech data to predict it. Secondary objectives include (1) evaluating whether similar algorithms can predict change in PACC5 between baseline and +12 month follow up in the cognitively normal (CN) and MCI populations separately; (2) evaluating whether similar algorithms trained to regress against PACC5 scores at baseline, still regress significantly against PACC5 scores at +12 month follow-up, as measured by the coefficient of individual agreement (CIA) between the PACC5 composite at +12 months and the regression model, trained on baseline speech data to predict PACC5 scores at baseline; (3) evaluating whether similar algorithms can classify converters vs non-converters in the cognitively normal Arms (Arm 3 + 4), and fast vs slow decliners in the MCI Arms (Arm 1 + 2), as measured by the AUC, sensitivity, specificity and Cohen's kappa of the corresponding binary classifiers. Secondary objectives include the objectives above, but using time points of +24 months and +36 months; and finally to evaluate whether the model performance for the objectives and outcomes above improved if the model has access to speech data at 1 week, 1 month, and 3 month timepoints.
- Conditions
- Alzheimer Disease, Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer's Disease (Incl Subtypes), Mild Cognitive Impairment
- Keywords
- Alzheimer's disease, Preclinical Alzheimer's disease, Prodromal Alzheimer's disease, Mild Cognitive Impairment, Normal Cognition, Amyloid, Speech, Acoustic, Language, Linguistic, Machine Learning, Artificial Intelligence
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Speech, Language
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 |
|---|---|---|
| Arm 1: MCI amyloid positive | * Meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria (2011) for MCI due to Alzheimer's or Mild Alzheimer's Dementia * Positive amyloid PET or amyloid CSF status. * MMSE 23-30 (inclusive) | |
| Arm 2: MCI amyloid negative | * Non-AD Mild Cognitive Impairment (MCI) * Negative amyloid PET or amyloid CSF status. * MMSE 23-30 (inclusive) | |
| Arm 3: CN amyloid positive | * Absence of a diagnosis of cognitive disorder and/or subjectively reported cognitive decline * Positive amyloid PET or amyloid CSF status. * MMSE 26-30 (inclusive) | |
| Arm 4: CN amyloid negative | * Absence of a diagnosis of cognitive disorder and/or subjectively reported cognitive decline * Negative amyloid PET or amyloid CSF status. * MMSE 26-30 (inclusive) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The agreement between the change in the PACC5 composite between baseline and +12 months and the corresponding regression model, trained on baseline speech data, predicting in all four Arms, as measured by the coefficient of individual agreement (CIA).
Baseline speech data is speech data collected during the first 14 days of the study for each participant.
Measured: 1 year
Secondary outcomes (8)
The agreement between changes in the PACC5 composite between baseline and +24, +36 months and the corresponding regression models, trained on baseline speech data, predicting in all 4 Arms, as measured by the coefficient of individual agreement (CIA).
Measured: 3 years
The agreement between the changes in the PACC5 composite between baseline and +12, +24, +36 months and the corresponding regression models, trained on baseline speech data, to predict them in the CN Arms (3 and 4), as measured by the CIA.
Measured: 3 years
The agreement between the changes in the PACC5 composite between baseline and +12, +24, +36 months and the corresponding regression models, trained on baseline speech data, predicting them in the MCI Arms (Arms 1 and 2), as measured by the CIA.
Measured: 3 years
The agreement between the PACC5 composite at +12, +24, +36 months and the corresponding regression models, trained on baseline speech data, predicting in all four Arms based on +12, +24, +36 month speech data, as measured by the CIA.
Measured: 3 years
The agreement between the PACC5 composite at +12, +24, +36 months and the corresponding regression models, trained on baseline speech data and +12, +24, +36 month speech data, as measured by the coefficient of individual agreement (CIA).
Measured: 3 years
The AUC, sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between converters vs non-converters in the cognitively normal (CN) Arms (Arms 3 and 4).
Converters defined as having a CDR Global score of 0.5 or more at +12, +24, +36 months.
Measured: 3 years
The AUC, sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +12, +24, +36 months.
Measured: 3 years
The outcomes above where the model has access to speech data at 1 month, 3 month time points, in addition to baseline speech data.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2021
- Study start19 Nov 2020
- Primary completion2 Dec 2022
- Study completion7 Jun 2024
Why it stopped: Study only continued to 2 year follow-up.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 67 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Novoic Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Emil Fristed, MSc, Principal investigator, Novoic Limited
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04846426
- Sponsor's protocol ID
- NOV-0100-1
- Acronym
- AMYPRED-FUTURE
- Status last verified
- Jun 2024
- First submitted
- 12 Apr 2021
- Last updated
- 14 Jun 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 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Evaluate the Ability of Speech- and Language-based Digital Biomarkers to Detect and Characterise Prodromal and Preclinical Alzheimer's Disease in a Clinical Setting - FUTURE Extension Study.
- ClinicalTrials.gov ID
- NCT04846426
- Acronym / sponsor ID
- AMYPRED-FUTURE / NOV-0100-1
- Conditions
- Alzheimer Disease, Preclinical Alzheimer's Disease, Prodromal Alzheimer's Disease, Alzheimer's Disease (Incl Subtypes), Mild Cognitive Impairment
- Keywords
- Alzheimer's disease, Preclinical Alzheimer's disease, Prodromal Alzheimer's disease, Mild Cognitive Impairment, Normal Cognition, Amyloid, Speech, Acoustic
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Study only continued to 2 year follow-up.
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Novoic LimitedIndustry (pharma, biotech, devices)
- Study start
- 19 Nov 2020 (actual)
- Primary completion
- 2 Dec 2022 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 15 Apr 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 whether a set of algorithms analysing acoustic and linguistic patterns of speech, can predict change in PACC5 between baseline and +12 month follow up across all four Arms, as measured by the coefficient of individual agreement (CIA) between the change in PACC5 and the corresponding regression model, trained on baseline speech data to predict it. Secondary objectives include (1) evaluating whether similar algorithms can predict change in PACC5 between baseline and +12 month follow up in the cognitively normal (CN) and MCI populations separately; (2) evaluating whether similar algorithms trained to regress against PACC5 scores at baseline, still regress significantly against PACC5 scores at +12 month follow-up, as measured by the coefficient of individual agreement (CIA) between the PACC5 composite at +12 months and the regression model, trained on baseline speech data to predict PACC5 scores at baseline; (3) evaluating whether similar algorithms can classify converters vs non-converters in the cognitively normal Arms (Arm 3 + 4), and fast vs slow decliners in the MCI Arms (Arm 1 + 2), as measured by the AUC, sensitivity, specificity and Cohen's kappa of the corresponding binary classifiers. Secondary objectives include the objectives above, but using time points of +24 months and +36 months; and finally to evaluate whether the model performance for the objectives and outcomes above improved if the model has access to speech data at 1 week, 1 month, and 3 month timepoints.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1: MCI amyloid positive | – | –* Meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria (2011) for MCI due to Alzheimer's or Mild Alzheimer's Dementia * Positive amyloid PET or amyloid CSF status. * MMSE 23-30 (inclusive) |
| Arm 2: MCI amyloid negative | – | –* Non-AD Mild Cognitive Impairment (MCI) * Negative amyloid PET or amyloid CSF status. * MMSE 23-30 (inclusive) |
| Arm 3: CN amyloid positive | – | –* Absence of a diagnosis of cognitive disorder and/or subjectively reported cognitive decline * Positive amyloid PET or amyloid CSF status. * MMSE 26-30 (inclusive) |
| Arm 4: CN amyloid negative | – | –* Absence of a diagnosis of cognitive disorder and/or subjectively reported cognitive decline * Negative amyloid PET or amyloid CSF status. * MMSE 26-30 (inclusive) |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be identified from participants of the AMYPRED study.
Key inclusion criteria (3 listed)
- Subjects are fully eligible for and have completed the AMYPRED (Amyloid Prediction in early stage Alzheimer's disease from acoustic and linguistic patterns of speech) study.
- (See https://clinicaltrials.gov/ct2/show/NCT04828122)
- Subject consents to take part in FUTURE extension study.
Key exclusion criteria (1 listed)
- Subject hasn't completed the full visit day in the AMYPRED study.
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 agreement between the change in the PACC5 composite between baseline and +12 months and the corresponding regression model, trained on baseline speech data, predicting in all four Arms, as measured by the coefficient of individual agreement (CIA).
Time frame: 1 year
Baseline speech data is speech data collected during the first 14 days of the study for each participant.
8 secondary outcomes
The agreement between changes in the PACC5 composite between baseline and +24, +36 months and the corresponding regression models, trained on baseline speech data, predicting in all 4 Arms, as measured by the coefficient of individual agreement (CIA).
Time frame: 3 years
The agreement between the changes in the PACC5 composite between baseline and +12, +24, +36 months and the corresponding regression models, trained on baseline speech data, to predict them in the CN Arms (3 and 4), as measured by the CIA.
Time frame: 3 years
The agreement between the changes in the PACC5 composite between baseline and +12, +24, +36 months and the corresponding regression models, trained on baseline speech data, predicting them in the MCI Arms (Arms 1 and 2), as measured by the CIA.
Time frame: 3 years
The agreement between the PACC5 composite at +12, +24, +36 months and the corresponding regression models, trained on baseline speech data, predicting in all four Arms based on +12, +24, +36 month speech data, as measured by the CIA.
Time frame: 3 years
The agreement between the PACC5 composite at +12, +24, +36 months and the corresponding regression models, trained on baseline speech data and +12, +24, +36 month speech data, as measured by the coefficient of individual agreement (CIA).
Time frame: 3 years
The AUC, sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between converters vs non-converters in the cognitively normal (CN) Arms (Arms 3 and 4).
Time frame: 3 years
The AUC, sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +12, +24, +36 months.
Time frame: 3 years
The outcomes above where the model has access to speech data at 1 month, 3 month time points, in addition to baseline speech data.
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Study only continued to 2 year follow-up.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 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.
Emil Fristed, MSc principal investigator
Novoic Limited
4 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 Preclinical Alzheimer's Disease, run by Novoic Limited at 4 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 3 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 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 was stopped early (reason given: Study only continued to 2 year follow-up.). 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?
The agreement between the change in the PACC5 composite between baseline and +12 months and the corresponding regression model, trained on baseline speech data, predicting in all four Arms, as measured by the coefficient of individual agreement (CIA). (time frame: 1 year). 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 14 Jun 2024.