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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neurocognitive Disorders
• Intervention / Treatment: Other: Series of cognitive tasks during a semi-automated call

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Eric ETTORE, MD; Phone Number: 04.92.03.47.70; Email: ettore.e@chu-nice.fr

Study Locations

• France
  • Nice, France, 06100
    • Recruiting
    • CHU de Nice
    • Contact: Lemaire Justine
    • Contact: Foussat Valérie
    • Sub-Investigator: Alexandra Konig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited through the Memory Clinic at the Geriatric Hospital in Nice (Centre de Mémoire de Ressources et de Recherche, CHU de Nice, Institut Claude Pompidou 10 rue Molière, 06 100 NICE) with a minor or major neurocognitive disorder whose etiology is either:

• Probable Alzheimer's disease (positive AD biomarkers)
• Mood disorder
• Not related to a mood disorder and with negative AD biomarkers

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2023
• Primary Completion (Estimated): July 13, 2024
• Study Completion (Estimated): August 13, 2024

Study Registration Dates

• First Submitted: July 5, 2023
• First Submitted That Met QC Criteria: July 5, 2023
• First Posted (Actual): July 13, 2023

Study Record Updates

• Last Update Posted (Actual): July 14, 2023
• Last Update Submitted That Met QC Criteria: July 13, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Mood disorder
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Mood Disorders; Neurocognitive Disorders
• Other Study ID Numbers: 23-PP-03

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