AMYPRED-FUTURE: Amyloid Prediction in Early Stage Alzheimer's Disease From Acoustic and Linguistic Patterns of Speech - FUTURE Extension

Sponsor
Novoic Limited (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04846426
Collaborator
(none)
140
4
41.8
35
0.8

Study Details

Study Description

Brief 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 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

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
140 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
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.
Actual Study Start Date :
Nov 19, 2020
Anticipated Primary Completion Date :
May 15, 2022
Anticipated Study Completion Date :
May 15, 2024

Arms and Interventions

Arm Intervention/Treatment
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)

Outcome Measures

Primary Outcome Measures

  1. 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). [1 year]

    Baseline speech data is speech data collected during the first 14 days of the study for each participant.

Secondary Outcome Measures

  1. 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). [3 years]

  2. 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. [3 years]

  3. 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. [3 years]

  4. 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. [3 years]

  5. 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). [3 years]

  6. 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). [3 years]

    Converters defined as having a CDR Global score of 0.5 or more at +12, +24, +36 months.

  7. 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. [3 years]

  8. The outcomes above where the model has access to speech data at 1 month, 3 month time points, in addition to baseline speech data. [3 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 85 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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 consents to take part in FUTURE extension study.
Exclusion Criteria:
  • Subject hasn't completed the full visit day in the AMYPRED study.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Re:Cognition Health Birmingham United Kingdom B16 8LT
2 Re:Cognition Health Guildford United Kingdom GU2 7YD
3 Re:Cognition Health London United Kingdom W1G9JF
4 Re:Cognition Health Plymouth United Kingdom PL68BT

Sponsors and Collaborators

  • Novoic Limited

Investigators

  • Principal Investigator: Emil Fristed, MSc, Novoic Limited

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Novoic Limited
ClinicalTrials.gov Identifier:
NCT04846426
Other Study ID Numbers:
  • NOV-0100-1
First Posted:
Apr 15, 2021
Last Update Posted:
Apr 15, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novoic Limited
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 15, 2021