Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis (PLATA)

Sponsor

Centre Hospitalier Universitaire de Nice (Other)

Overall Status

Recruiting

CT.gov ID

NCT05943834

Collaborator

(none)

100

Enrollment

Location

Anticipated Duration (Months)

7.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

PLATA aims to develop an algorithm to identify vocal biomarkers of Alzheimer's dementia.

Using data collected as part of routine care, speech patterns will be compared to known biomarkers of Alzheimer's disease, such as amyloid 1-42 and p-Tau in CSF (cerebrospinal fluid).

If biomarkers of speech can be identified in Alzheimer's disease, it is possible that patients and research participants will no longer need to undergo need to undergo the intensive and invasive baseline biomarker methods currently used, such as lumbar punctures and PET scans.

Condition or Disease	Intervention/Treatment	Phase
Neurocognitive Disorders	Other: Series of cognitive tasks during a semi-automated call

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis

Actual Study Start Date :

Jul 13, 2023

Anticipated Primary Completion Date :

Jul 13, 2024

Anticipated Study Completion Date :

Aug 13, 2024

Arms and Interventions

Arm	Intervention/Treatment
Patients with a minor or major neurocognitive disorder Every patient will receive one semi-automated phone call, during the call a series of cognitive tasks will be performed. Each task will be recorded in a secondary audio stream which records the participant responses to allow for deep speech analysis of performance on these tasks	Other: Series of cognitive tasks during a semi-automated call Tasks: Verbal learning recall (immediate) or Story Recall task (immediate) Narrative Storytelling /free speech Verbal fluency task Verbal learning recall (delayed) or Story Recall task (delayed)

Arm

Intervention/Treatment

Patients with a minor or major neurocognitive disorder

Every patient will receive one semi-automated phone call, during the call a series of cognitive tasks will be performed. Each task will be recorded in a secondary audio stream which records the participant responses to allow for deep speech analysis of performance on these tasks

Other: Series of cognitive tasks during a semi-automated call

Tasks: Verbal learning recall (immediate) or Story Recall task (immediate) Narrative Storytelling /free speech Verbal fluency task Verbal learning recall (delayed) or Story Recall task (delayed)

Outcome Measures

Primary Outcome Measures

Build and validate speech-based machine learning models for relevant Phenotype detection through access to phenotyped patients from reference memory center. [20 minutes]
Speech biomarker algorithm(s)

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age ≥ 50 years
Diagnosis relevant biomarker and neuropsychological data already available
Cognitively healthy to very mild dementia (CDR score max. 0.5)
Sufficient knowledge of the study language to understand study information, non opposition form,and questionnaires
Expression of non opposition

Exclusion Criteria:

Hearing problems
Patient protected by law, under guardianship or curator ship, or not able to participate in a clinical study according to the article L.1121-16 of the French Public Health Code

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Nice	Nice		France	06100

Sponsors and Collaborators

Centre Hospitalier Universitaire de Nice

Investigators

Principal Investigator: Eric ETTORE, MD, Centre Hospitalier Universitaire de Nice

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de Nice

ClinicalTrials.gov Identifier:

NCT05943834

Other Study ID Numbers:

23-PP-03

First Posted:

Jul 13, 2023

Last Update Posted:

Jul 14, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Centre Hospitalier Universitaire de Nice

Alzheimer's disease

Mood disorder

Additional relevant MeSH terms:

Alzheimer Disease

Mood Disorders

Neurocognitive Disorders

Study Results

No Results Posted as of Jul 14, 2023