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

Neurocognitive Disorders Clinical Trial

— PLATA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05943834
• Other study ID #: 23-PP-03
• Status: Recruiting
• Start date: July 13, 2023
• Est. completion date: August 13, 2024

Study information

• Verified date: July 2023
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Eric ETTORE, MD
• Phone: 04.92.03.47.70
• Email: ettore.e[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 13, 2024
• Est. primary completion date: July 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Mood Disorders
• Neurocognitive Disorders

Intervention

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)

Locations

Country	Name	City	State
France	CHU de Nice	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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