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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
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

  • United States
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Alzheimer's Disease
Those individuals who possess a significant amyloid burden per results of a previous amyloid PET scan radiology report.
Other: Audio speech recording
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.
Other: Audio speech recording
Audio recording of speech sample from subject description of Cookie-Theft image.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
East Tennessee State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 13, 2018

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2020

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 29, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 1, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 22, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 17, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0218.16sw

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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