NCT04041895

Brief Summary

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

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 13, 2018

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 29, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2020

Completed
Last Updated

November 22, 2022

Status Verified

November 1, 2022

Enrollment Period

2 years

First QC Date

July 29, 2019

Last Update Submit

November 17, 2022

Conditions

Alzheimer DiseaseDementia

Keywords

Alzheimer's DiseaseDementiaLinguistics

Outcome Measures

Primary Outcomes (1)

  • Analysis of speech audio recording describing the "Cookie-Thief Image" using proposed computational model designed by PI for determination of Alzheimer's disease

    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 Outcomes (1)

  • MMSE

    through study completion, an average of 1 year

Study Arms (2)

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

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

Interventions

Audio speech recordingOTHER

Audio recording of speech sample from subject description of Cookie-Theft image.

Alzheimer's DiseaseControl

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Tennessee State University

Johnson City, Tennessee, 37614, United States

Location

Related Publications (10)

  • Orimaye, S. O., Wong, J. S. M., & Golden, K. J. (2014, June). Learning predictive linguistic features for Alzheimer's disease and related dementias using verbal utterances. In Proceedings of the 1st Workshop on Computational Linguistics and Clinical Psychology (CLPsych) (pp. 78-87). sn.

    BACKGROUND

  • Orimaye SO, Wong JS, Golden KJ, Wong CP, Soyiri IN. Predicting probable Alzheimer's disease using linguistic deficits and biomarkers. BMC Bioinformatics. 2017 Jan 14;18(1):34. doi: 10.1186/s12859-016-1456-0.

    PMID: 28088191BACKGROUND

  • Roark B, Mitchell M, Hosom JP, Hollingshead K, Kaye J. Spoken Language Derived Measures for Detecting Mild Cognitive Impairment. IEEE Trans Audio Speech Lang Process. 2011 Sep 1;19(7):2081-2090. doi: 10.1109/TASL.2011.2112351.

    PMID: 22199464BACKGROUND

  • Fraser KC, Meltzer JA, Graham NL, Leonard C, Hirst G, Black SE, Rochon E. Automated classification of primary progressive aphasia subtypes from narrative speech transcripts. Cortex. 2014 Jun;55:43-60. doi: 10.1016/j.cortex.2012.12.006. Epub 2012 Dec 21.

    PMID: 23332818BACKGROUND

  • Prud'hommeaux E, Roark B. Graph-Based Word Alignment for Clinical Language Evaluation. Comput Linguist Assoc Comput Linguist. 2015 Dec;41(4):549-578. doi: 10.1162/coli_a_00232. Epub 2015 Dec 1.

    PMID: 34334943BACKGROUND

  • Verma M, Howard RJ. Semantic memory and language dysfunction in early Alzheimer's disease: a review. Int J Geriatr Psychiatry. 2012 Dec;27(12):1209-17. doi: 10.1002/gps.3766. Epub 2012 Feb 1.

    PMID: 22298328BACKGROUND

  • Reilly J, Rodriguez AD, Lamy M, Neils-Strunjas J. Cognition, language, and clinical pathological features of non-Alzheimer's dementias: an overview. J Commun Disord. 2010 Sep-Oct;43(5):438-52. doi: 10.1016/j.jcomdis.2010.04.011. Epub 2010 May 6.

    PMID: 20493496BACKGROUND

  • Klimova B, Maresova P, Valis M, Hort J, Kuca K. Alzheimer's disease and language impairments: social intervention and medical treatment. Clin Interv Aging. 2015 Aug 27;10:1401-7. doi: 10.2147/CIA.S89714. eCollection 2015.

    PMID: 26346123BACKGROUND

  • Fraser KC, Meltzer JA, Rudzicz F. Linguistic Features Identify Alzheimer's Disease in Narrative Speech. J Alzheimers Dis. 2016;49(2):407-22. doi: 10.3233/JAD-150520.

    PMID: 26484921BACKGROUND

  • 10. Lunsford, R., & Heeman, P. A. (2015, September). Using linguistic indicators of difficulty to identify mild cognitive impairment. In INTERSPEECH (pp. 658-662).

    BACKGROUND

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Sylvester O Orimaye, PhD, MPH

    East Tennessee State University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate in the College of Public Health

Study Record Dates

First Submitted

July 29, 2019

First Posted

August 1, 2019

Study Start

August 13, 2018

Primary Completion

August 1, 2020

Study Completion

August 1, 2020

Last Updated

November 22, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)