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

Sponsor

Novoic Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04851496

Collaborator

(none)

Enrollment

Locations

21.3

Anticipated Duration (Months)

Patients Per Site

0.9

Patients Per Site Per Month

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 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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Preclinical Alzheimer's Disease Prodromal Alzheimer's Disease Alzheimer's Disease (Incl Subtypes) Mild Cognitive Impairment

Study Design

Study Type:

Observational

Anticipated Enrollment :

80 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

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 - PAST Extension Study.

Actual Study Start Date :

Nov 19, 2020

Anticipated Primary Completion Date :

Aug 30, 2022

Anticipated Study Completion Date :

Aug 30, 2022

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

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. [Up to 85 years]
Using archival spoken or written language samples as input.

Secondary Outcome Measures

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. [Up to 85 years]
The AUC, sensitivity, specificity and Cohen's kappa of the binary classifiers distinguishing between MCI and cognitively normal (CN) arms. [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.
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. [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.

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 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.

Contacts and Locations

Locations

	Site	City	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