Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech - PAST Extension (AMYPRED-PAST)

April 6, 2022 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 - PAST Extension Study.

The primary objective of the study is to evaluate whether a set of algorithms analysing acoustic and linguistic patterns of speech can detect amyloid-specific cognitive impairment in early stage Alzheimer's disease, based on archival spoken or written language samples, as measured by the AUC of the receiver operating characteristic curve of the binary classifier distinguishing between amyloid positive and amyloid negative arms. Secondary objectives include (1) evaluating how many years before diagnosis of MCI such algorithms work, as measured on binary classifier performance of the classifiers trained to classify MCI vs cognitively normal (CN) arms using archival material from the following time bins before MCI diagnosis: 0-5 years, 5-10 years, 10-15 years, 15-20 years, 20-25 years; (2) evaluating at what age such algorithms can detect later amyloid positivity, as measured on binary classifier performance of the classifiers trained to classify amyloid positive vs amyloid negative arms using archival material from the following age bins: younger than 50, 50-55, 55-60, 65-70, 70-75 years old.

Study Overview

Study Type

Observational

Enrollment (Anticipated)

80

Contacts and Locations

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

Study Contact

Study Locations

      • Birmingham, United Kingdom, B16 8LT
        • Recruiting
        • Re:Cognition Health
        • Contact:
          • Clinical Trials Centre Manager
      • Guildford, United Kingdom, GU2 7YD
        • Recruiting
        • Re:Cognition Health
        • Contact:
          • Clinical Trials Centre Manager
      • London, United Kingdom, W1G9JF
        • Recruiting
        • Re:Cognition Health
        • Contact:
          • Clinical Trials Centre Manager
      • Plymouth, United Kingdom, PL68BT
        • Recruiting
        • Re:Cognition Health
        • Contact:
          • Clinical Trials Centre Manager

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

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants will be identified from participants of the AMYPRED study.

Description

Inclusion Criteria:

  • 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 has access to audio or written recordings created by them that are available for collection.
  • Subject consents to take part in PAST extension study.

Exclusion Criteria:

  • Subject hasn't completed the full visit day in the AMYPRED 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

  • Observational Models: Case-Control
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary outcome measure is the area under the curve (AUC) of the receiver operating characteristic (ROC) curve of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) arms.
Time Frame: Up to 85 years
Using archival spoken or written language samples as input.
Up to 85 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) arms using archival spoken or written language samples as input.
Time Frame: Up to 85 years
Up to 85 years
The AUC, sensitivity, specificity and Cohen's kappa of the binary classifiers distinguishing between MCI and cognitively normal (CN) arms.
Time Frame: Up to 85 years
Using archival spoken or written language samples as input in the following bins: 0-5 years, 5-10 years, 10-15 years, 15-20 years, 20-25 years before MCI diagnosis.
Up to 85 years
The AUC, sensitivity, specificity and Cohen's kappa of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) arms.
Time Frame: Up to 85 years
Using archival spoken or written language samples as input in the following bins: younger than 50, 50-55, 55-60, 65-70, 70-75 years old.
Up to 85 years

Collaborators and Investigators

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

Sponsor

Investigators

  • Principal Investigator: Emil Fristed, MSc, Novoic Limited

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)

November 19, 2020

Primary Completion (Anticipated)

August 30, 2022

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

April 12, 2021

First Submitted That Met QC Criteria

April 15, 2021

First Posted (Actual)

April 20, 2021

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

April 6, 2022

Last Verified

April 1, 2021

More Information

Terms related to this study

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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