Amyloid Prediction in Early Stage Alzheimer's Disease Through Speech Phenotyping - PAST Extension

NCT04937959 | Unknown

• 1 other identifier: NOV-0110-2
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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 area under the curve (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 Mild Cognitive Impairment (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.

Conditions

Alzheimer Disease; Alzheimer's Disease (Incl Subtypes); Preclinical Alzheimer's Disease; Prodromal Alzheimer's Disease; Mild Cognitive Impairment; Normal Cognition

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Using archival spoken or written language samples as input.

  Up to 85 years

Secondary Outcomes (11)

• The sensitivity 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 specificity 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 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 of the binary classifiers distinguishing between MCI and cognitively normal (CN) arms.

  Up to 85 years

• The sensitivity of the binary classifiers distinguishing between MCI and cognitively normal (CN) arms.

  Up to 85 years

Study Arms (4)

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)

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)

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Novoic Limited: lead

Study Sites (1)

Syrentis Clinical Research

Santa Ana, California, 92705, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction; Speech; Language

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Verbal Behavior; Communication; Behavior

Study Officials

• Emil Fristed, MSc

  Novoic Ltd

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Head of Clinical Operations

CONTACT

07849522891; s2@novoic.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 24, 2021
• Study Start: January 22, 2021
• Primary Completion: August 30, 2022
• Study Completion: August 30, 2022
• Last Updated: April 7, 2022

Record last verified: 2021-06

Locations

US (1)