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

NCT ID: NCT05943834

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-13

Study Completion Date

2025-10-10

Brief Summary

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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.

Detailed Description

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Conditions

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Neurocognitive Disorders

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Series of cognitive tasks during a semi-automated call

Intervention Type OTHER

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)

Interventions

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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)

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric ETTORE, MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire de Nice

Locations

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CHU de Nice

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Eric ETTORE, MD

Role: CONTACT

04.92.03.47.70

Facility Contacts

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Lemaire Justine

Role: primary

Foussat Valérie

Role: backup

Other Identifiers

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23-PP-03

Identifier Type: -

Identifier Source: org_study_id

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