Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - FUTURE Extension (FUTURE-US)

June 12, 2024 updated by: Novoic Limited

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 - AMYPRED-US 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 Preclinical Alzheimer's Clinical Composite with semantic processing (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 Area Under the Curve (AUC) of the receiver operating characteristic curve, 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Santa Ana, California, United States, 92705
        • Syrentis Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants will be identified from participants of the AMYPRED-US study.

Description

Inclusion Criteria:

  • Subjects are fully eligible for and have completed the AMYPRED-US (Amyloid Prediction in early stage Alzheimer's disease from acoustic and linguistic patterns of speech) study.

(See https://clinicaltrials.gov/ct2/show/NCT04928976)

- Subject consents to take part in FUTURE extension study.

Exclusion Criteria:

  • Subject hasn't completed the full visit day in the AMYPRED-US study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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)
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
  • Positive amyloid PET or amyloid CSF status.
  • MMSE 23-30 (inclusive)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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: 12 months
12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
The agreement between the change in the PACC5 composite between baseline and +24 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: 24 months
24 months
The agreement between the change in the PACC5 composite between baseline and +36 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: 36 months
36 months
The agreement between the change in the PACC5 composite between baseline and +12 months and the corresponding regression model, trained on baseline speech data, to predict it in the CN Arms (Arms 3 and 4), as measured by the CIA.
Time Frame: 12 months
12 months
The agreement between the change in the PACC5 composite between baseline and +24 months and the corresponding regression model, trained on baseline speech data, to predict it in the CN Arms (Arms 3 and 4), as measured by the CIA.
Time Frame: 24 months
24 months
The agreement between the change in the PACC5 composite between baseline and +36 months and the corresponding regression model, trained on baseline speech data, predicting it in the MCI Arms (Arms 1 and 2), as measured by the CIA.
Time Frame: 36 months
36 months
The agreement between the PACC5 composite at +12 months and the corresponding regression model, trained on baseline speech data, predicting in all four Arms based on +12 month speech data, as measured by the coefficient of individual agreement (CIA).
Time Frame: 12 months
12 months
The agreement between the PACC5 composite at +24 months and the corresponding regression model, trained on baseline speech data, predicting in all four Arms based on +12 month speech data, as measured by the coefficient of individual agreement (CIA).
Time Frame: 24 months
24 months
The agreement between the PACC5 composite at +36 months and the corresponding regression model, trained on baseline speech data, predicting in all four Arms based on +12 month speech data, as measured by the coefficient of individual agreement (CIA).
Time Frame: 36 months
36 months
The agreement between the PACC5 composite and the corresponding regression model, trained on baseline speech data and +12 month speech data, as measured by the coefficient of individual agreement (CIA).
Time Frame: 12 months
12 months
The agreement between the PACC5 composite and the corresponding regression model, trained on baseline speech data and +24 month speech data, as measured by the coefficient of individual agreement (CIA).
Time Frame: 24 months
24 months
The agreement between the PACC5 composite and the corresponding regression model, trained on baseline speech data and +36 month speech data, as measured by the coefficient of individual agreement (CIA).
Time Frame: 36 months
36 months
The AUC 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 months.
Time Frame: 12 months
12 months
The AUC 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 +24 months.
Time Frame: 24 months
24 months
The AUC 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 +36 months.
Time Frame: 36 months
36 months
The sensitivity 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 months.
Time Frame: 12 months
12 months
The sensitivity 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 +24 months.
Time Frame: 24 months
24 months
The sensitivity 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 +36 months.
Time Frame: 36 months
36 months
The specificity 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 months.
Time Frame: 12 months
12 months
The specificity 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 +24 months.
Time Frame: 24 months
24 months
The specificity 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 +36 months.
Time Frame: 36 months
36 months
The 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 months.
Time Frame: 12 months
12 months
The 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 +24 months.
Time Frame: 24 months
24 months
The 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 +36 months.
Time Frame: 36 months
36 months
The AUC of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +12 months.
Time Frame: 12 months
12 months
The AUC of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +24 months.
Time Frame: 24 months
24 months
The AUC of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +36 months.
Time Frame: 36 months
36 months
The sensitivity of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +12 months.
Time Frame: 12 months
12 months
The sensitivity of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +24 months.
Time Frame: 24 months
24 months
The sensitivity of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +36 months.
Time Frame: 36 months
36 months
The specificity of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +12 months.
Time Frame: 12 months
12 months
The specificity of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +24 months.
Time Frame: 24 months
24 months
The specificity of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +36 months.
Time Frame: 36 months
36 months
The Cohen's kappa of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +12 months.
Time Frame: 12 months
12 months
The Cohen's kappa of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +24 months.
Time Frame: 24 months
24 months
The Cohen's kappa of the binary classifier distinguishing between fast decliners vs slow decliners in the MCI Arms (Arms 1 and 2) at +36 months.
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Novoic Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Emil Fristed, MSc, Novoic Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 21, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 28, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 17, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 6, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 14, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NOV-0110-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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