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

NCT04928976 | Completed

• 1 other identifier: NOV-0110
• Study Type: observational
• Target: 67
• 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, as measured by the 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. Secondary objectives include (1) evaluating whether similar algorithms can detect amyloid-specific cognitive impairment in the cognitively normal (CN) and MCI Arms respectively, as measured on binary classifier performance; (2) whether they can detect MCI, as measured on binary classifier performance (AUC, sensitivity, specificity, Cohen's kappa), and the agreement between the PACC5 composite and the corresponding regression model predicting it in all Arms pooled (Wilcoxon signed-rank test, CIA); (3) evaluating variables that can impact performance of such algorithms of covariates from the speaker (age, gender, education level) and environment (measures of acoustic quality).

Conditions

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

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)

• 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 speech recordings as input.

  baseline

Secondary Outcomes (17)

• The sensitivity of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) Arms.

  baseline

• The specificity of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) Arms.

  baseline

• The Cohen's kappa of the binary classifier distinguishing between amyloid positive (Arms 1 and 3) and amyloid negative (Arms 2 and 4) Arms.

  baseline

• The sensitivity of the binary classifier distinguishing between amyloid positive cognitively normal (CN) (Arm 3) and amyloid negative cognitively normal (CN) (Arm 4) Arms.

  baseline

• The specificity of the binary classifier distinguishing between amyloid positive cognitively normal (CN) (Arm 3) and amyloid negative cognitively normal (CN) (Arm 4) Arms.

  baseline

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 primarily through data-base searches of the Investigator sites.

You may qualify if:

• Amyloid status must be known, based on an amyloid PET scan or CSF amyloid test, no older than 30 months at the time of consent for Arm 2 and Arm 4 participants (amyloid negative Arms).
• Amyloid status must be known, based on an amyloid PET scan or CSF amyloid test, no older than 60 months at the time of consent for Arm 1 and Arm 3 (amyloid positive Arms).
• Subjects must be aged 50-85 (inclusive).
• Subjects must have MMSE scores of 23-30 (inclusive) based on a test not older than 1 month at the time of the visit.
• Date of diagnosis (if applicable) maximum of five years prior to consent.
• Subjects' first language must be English.
• Willing to participate in a study investigating speech and dementia.
• Availability of a person ('caregiver') who in the investigator's judgment has frequent and sufficient in-person contact with the participant, and is able to provide accurate information regarding the participant's cognitive and functional abilities. This is most likely met when living with a caregiver.
• Able to provide valid informed consent.
• Able to use, or has a caregiver who is able to use a smartphone device.
• Has access to a smartphone device running an operation system of Android 6 or above; or iOS 10 or above.
• Able to use, or has a caregiver who is able to use a personal computer, notebook or tablet.
• Has access to a personal computing device of that is:
• Running an operating system of macOS X with macOS 10.9 or later; or Windows 7 or above; or Ubuntu 12.04 or higher; or
• Have access to one of following internet browser software Internet Explorer version 11 or above; or Microsoft Edge version 12 or above; or Firefox version 27 or above; or Google Chrome version 30 or above; or Safari version 7 or above; capable of audio and video recording; and able to connect to the internet.

You may not qualify if:

• Clinically significant unstable psychiatric illness in 6 months.
• Diagnosis of General Anxiety Disorder.
• Current, or history within the past 2 years of major depressive disorder diagnosis (according to DSM-5 criteria); or psychiatric symptoms that, in the opinion of the investigator, could interfere with study procedures.
• History or presence of stroke within the past 2 years.
• Documented history of transient ischemic attack or unexplained loss of consciousness within the last 12 months.
• The participant is using drugs to treat symptoms related to AD, and the doses of these drugs were not stable for at least 8 weeks prior to consent.

Sponsors & Collaborators

• Novoic Limited: lead

Study Sites (1)

Syrentis Clinical Research

Santa Ana, California, 92705, United States

Location

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 Limited

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 2 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 16, 2021
• Study Start: January 22, 2021
• Primary Completion: July 30, 2021
• Study Completion: July 30, 2021
• Last Updated: September 5, 2021

Record last verified: 2021-06

Locations

US (1)