Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis
New trial uses voice analysis to detect early signs of Alzheimer's
Plain English Summary
Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis (PLATA) is a Not Applicable clinical trial sponsored by Centre Hospitalier Universitaire de Nice studying Neurocognitive Disorders. This study tests if changes in voice and speech can help identify early signs of Alzheimer's disease and related mood disorders. It is for individuals aged 50 and older who have some cognitive changes but are not severely impaired. Participation involves speaking during a phone call where specific cognitive tasks are performed. Currently, early detection often relies on more invasive tests like lumbar punctures or PET scans. The trial aims to enroll 100 participants.
Official 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.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are 50 or older and have existing medical data showing relevant biomarkers and cognitive test results. Participants should have mild cognitive changes (dementia rating scale score of 0.5 or less) and understand the study language. You cannot join if you have hearing problems, are under legal protection (guardianship), or are unable to participate in studies. You must agree to participate and understand the study information. This trial is studying Neurocognitive Disorders, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how well a computer program can learn from speech patterns to identify signs of Alzheimer's, meaning a future tool could help doctors spot the disease earlier through simp The specific primary outcome measures are: Build and validate speech-based machine learning models for relevant Phenotype detection through access to phenotyped patients from reference memory center. (20 minutes). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This study does not have a traditional clinical phase designation. It may be an observational study that follows patients without intervening in their care, an expanded access or compassionate use program, or other non-interventional research. These studies contribute valuable data about disease progression, treatment patterns, and patient outcomes.
Why This Trial Matters
This trial aims to find a less invasive way to detect Alzheimer's disease early by analyzing voice patterns, potentially reducing the need for current intensive diagnostic methods. This research targets Neurocognitive Disorders, where improved treatment options are needed.
Investor Insight
This trial signals a growing interest in AI-driven diagnostics for neurodegenerative diseases, a market with significant unmet needs and potential for innovative solutions.
Is This Trial Right for Me?
Ask your doctor if your current cognitive status and medical history make you a good candidate for this study. Participation involves a phone call where you will be asked to complete several speaking tasks. The call is expected to take about 20 minutes and will be conducted in French. This trial is currently recruiting participants. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: OBSERVATIONAL
- Enrollment: 100 participants
Interventions
- 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)
Primary Outcomes
- Build and validate speech-based machine learning models for relevant Phenotype detection through access to phenotyped patients from reference memory center. (20 minutes)
Full Eligibility Criteria
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
Trial Locations
- CHU de Nice, Nice, France
Frequently Asked Questions
What is clinical trial NCT05943834?
NCT05943834 is a Not Applicable OBSERVATIONAL study titled "Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis (PLATA)." It is currently recruiting and is sponsored by Centre Hospitalier Universitaire de Nice. The trial targets enrollment of 100 participants.
What conditions does NCT05943834 study?
This trial investigates treatments for Neurocognitive Disorders. The primary condition under study is Neurocognitive Disorders.
What treatments are being tested in NCT05943834?
The interventions being studied include: Series of cognitive tasks during a semi-automated call (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)
What does Not Applicable mean for NCT05943834?
This study does not have a defined clinical phase. It may be an observational study, expanded access program, or other non-interventional research.
What is the current status of NCT05943834?
This trial is currently "Recruiting." It started on 2023-07-13. The estimated completion date is 2027-10-10.
Who is sponsoring NCT05943834?
NCT05943834 is sponsored by Centre Hospitalier Universitaire de Nice. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT05943834?
The trial aims to enroll 100 participants. The trial is currently recruiting and accepting new participants.
How is NCT05943834 designed?
This is a observational study.
What are the primary outcomes being measured in NCT05943834?
The primary outcome measures are: Build and validate speech-based machine learning models for relevant Phenotype detection through access to phenotyped patients from reference memory center. (20 minutes). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT05943834 being conducted?
This trial is being conducted at 1 site, including Nice (France).
Where can I find official information about NCT05943834?
The official record for NCT05943834 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT05943834. This government database provides the most up-to-date and detailed information about the trial.
What is NCT05943834 testing in simple terms?
This study tests if changes in voice and speech can help identify early signs of Alzheimer's disease and related mood disorders. It is for individuals aged 50 and older who have some cognitive changes but are not severely impaired.
Why is this trial significant?
This trial aims to find a less invasive way to detect Alzheimer's disease early by analyzing voice patterns, potentially reducing the need for current intensive diagnostic methods.
What are the potential risks of participating in NCT05943834?
The main risk is that the voice analysis might not accurately detect early signs of Alzheimer's or related disorders. Potential side effects are minimal, mainly related to the time commitment and the possibility of mild discomfort discussing cognitive changes. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT05943834?
Ask your doctor if your current cognitive status and medical history make you a good candidate for this study. Participation involves a phone call where you will be asked to complete several speaking tasks. The call is expected to take about 20 minutes and will be conducted in French. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT05943834 signal from an investment perspective?
This trial signals a growing interest in AI-driven diagnostics for neurodegenerative diseases, a market with significant unmet needs and potential for innovative solutions. This is a Not Applicable trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves speaking during a phone call where specific cognitive tasks are performed. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.