Detecting Probable Alzheimer's Disease From Speech Using Linguistical Analysis

November 17, 2022 updated by: Sylvester Olubolu Orimaye, East Tennessee State University

Detecting Mild Cognitive Impairment and Probable Alzheimer's Disease From Speech Using Linguistic Deficits With Amyloid PET Imaging as a Baseline.

The object of this study is to investigate the use of linguistic deficits from speech samples for the early detection of Mild Cognitive Impairment and probable Alzheimer's disease. It will also evaluate whether the result of the Amyloid PET scan would confirm the effectiveness of a less expensive and less intrusive diagnostic technique through speech

Study Overview

Status

Withdrawn

Intervention / Treatment

Detailed Description

This study will investigate the use of linguistic deficits through a computational diagnostic model for the prediction of Mild Cognitive Impairment (MCI) and Probable Alzheimer's disease (PrAD) from speech samples (verbal utterances). The premise is that MCI and PrAD are characterized by the deterioration of nerve cells that control cognitive speech and language processes, which consequently affects how patients compose verbal utterances. As the Amyloid Positron Emission Tomography (PET) scan is making advances in giving confirmatory evidence of the existence of plaques in the brain, there is the opportunity to investigate whether the result of the scan would confirm the effectiveness of a less expensive and less intrusive diagnostic technique. In this study, participants of a previous IRB approved study on Imaging Dementia-Evidence for Amyloid Scanning (IDEAS) who consent to participate in the new study will be requested to perform a basic descriptive task. The main task to be done by the participants is to verbally describe the scenes on a projected image, while their verbal utterances will be recorded via an audio recorder. The descriptive task is expected to take between 10 to 15 minutes on average. Participants will be required to describe the scenes on the projected Cookie-Theft image (http://www.amyspeechlanguagetherapy.com/thecookie- theft-picture.html). The image is part of the Provide a brief but thorough description of the study. What is the study about? This does not need to contain a summary of background literature. It should just summarize the study itself. Boston Diagnostic Aphasia Examination (BDAE-3) and it is adapted in our study for the purpose of capturing the complexity in the linguistic expression similar to the DementiaBank project (https://talkbank.org/media/DementiaBank/Pitt/cookie/). Note that we are NOT conducting any psychological examination using the BDAE-3, we have only referenced the source of the Cookie-Theft image, which is publicly available for research and has been used for decades. An example of the task is demonstrated in this video: https://www.youtube.com/watch?v=1NB8wBBguMg. The transcripts of the recorded interview will be analyzed by our proposed computational model to detect the presence of Mild Cognitive Impairment or probable Alzheimer's disease. Finally, the IDEAS study PET scan data would be used in conjunction with the transcripts of the recorded interview to compare the results of the linguistic analysis of the transcript with those of the PET scan in making Mild Cognitive Impairment or probable Alzheimer's Disease diagnoses.

Study Type

Observational

Contacts and Locations

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

Study Locations

    • Tennessee
      • Johnson City, Tennessee, United States, 37614
        • East Tennessee State University

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Participants would have undertaken an Amyloid PET scan to confirm the presence or absence of Amyloid plaques in the brain through a previously approved study on Alzheimer's disease with Amyloid PET imaging or at the request of their physician to determine possible cause of suspected cognitive decline.

Description

Inclusion Criteria:

  • Participants who have undergone the Mini Mental State Examination (MMSE).
  • Participants who have undergone Amyloid PET scan with a diagnosis of having the Amyloid plaques or not.
  • Participants with moderate or fluent English speaking ability.

Exclusion Criteria:

  • Participants who cannot speak as the data collection process needs to obtain speech samples.
  • Participants who are severely demented or at a very late stage of Alzheimer's disease.
  • Participants with stroke.
  • Participants who report a history of other neurodegenerative disorders than MCI and AD.
  • Participants with chronic vision impairment or who cannot see with the aid of corrective glasses.
  • Participants who cannot speak English.
  • A participant who have been diagnosed with HIV/AIDS as this may have a cognitive effect on its own.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Alzheimer's Disease
Those individuals who possess a significant amyloid burden per results of a previous amyloid PET scan radiology report.
Audio recording of speech sample from subject description of Cookie-Theft image.
Control
Those individuals who do not possess a significant amyloid burden per results of a previous amyloid PET scan radiology report.
Audio recording of speech sample from subject description of Cookie-Theft image.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of speech audio recording describing the "Cookie-Thief Image" using proposed computational model designed by PI for determination of Alzheimer's disease
Time Frame: through study completion, an average of 1 year
Analysis of speech audio recording of participants description of Cookie-Thief Image The image is part of the Provide a brief but thorough description of the study. What is the study about? This does not need to contain a summary of background literature. It should just summarize the study itself. Boston Diagnostic Aphasia Examination (BDAE-3) and it is adapted in our study for the purpose of capturing the complexity in the linguistic expression similar to the DementiaBank project (https://talkbank.org/media/DementiaBank/Pitt/cookie/) using proposed computational model for determination of Alzheimer's disease
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MMSE
Time Frame: through study completion, an average of 1 year
Mini Mental State Examination
through study completion, an average of 1 year

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Sylvester O Orimaye, PhD, MPH, East Tennessee State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 13, 2018

Primary Completion (Anticipated)

August 1, 2020

Study Completion (Anticipated)

August 1, 2020

Study Registration Dates

First Submitted

July 29, 2019

First Submitted That Met QC Criteria

July 30, 2019

First Posted (Actual)

August 1, 2019

Study Record Updates

Last Update Posted (Actual)

November 22, 2022

Last Update Submitted That Met QC Criteria

November 17, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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