Task-evoked Pupillometry in AD, MCI, and Depression-Related Cognitive Impairment
VR eye-tracking trial for cognitive decline in Alzheimer's, MCI, and depression
Plain English Summary
VR Pupillometry in Cognitive Impairment is a Not Applicable clinical trial sponsored by Max-Planck-Institute of Psychiatry studying Alzheimer s Disease, Major Depressive Disorder (MDD), Mild Cognitive Impairment, Dementia. This study tests if a virtual reality (VR) eye-tracking test can detect early signs of cognitive decline. It is for adults aged 18-80 who have Alzheimer's disease, mild cognitive impairment, or depression with cognitive issues, as well as healthy individuals. Participation involves eye-tracking tests using VR and standard cognitive assessments over 6 months. Currently, cognitive decline is often assessed with paper-and-pencil tests; this study explores a new, objective VR-based method. The trial aims to enroll 140 participants.
Official Summary
With disease-modifying therapies emerging for dementia and related conditions, identifying cognitive decline as early as possible is increasingly important. This prospective, single-center, repeated-measures study evaluates whether VR-based eye-tracking pupillometry can provide a practical, non-invasive biomarker of cognitive impairment and its progression over time. Pupil responses are linked to brain arousal systems relevant to cognitive dysfunction, including the locus coeruleus, which is affected early in Alzheimer's disease. Adults aged 18-80 years will be assigned to one of four cohorts (n=35 per cohort): i) Alzheimer's disease (supported by CSF biomarkers), ii) mild cognitive impairment (MCI) without Alzheimer's Disease, iii) depressive disorder with cognitive impairment, iv) healthy controls. Participants will undergo initial assessments at baseline and follow-up visits after 3 and 6 months. At each visit, pupil responses and behavioral metrics are recorded during a pupillary light reflex paradigm, a resting-state fixation block, a working-memory task (N-back), and a reward task. Pupillometric and behavioral metrics will be compared across cohorts and related to routine neuropsychological measures (MoCA, CERAD) and available clinical biomarkers (CSF markers; blood biomarkers). The primary objective is to determine whether task-evoked pupil response profiles sensitively quantify cognitive impairment, differ between cohorts, and track change over time. The long-term goal is to validate an easy-to-use, outpatient-compatible assessment to support objective characterization and monitoring of cognitive disorders.
Who Can Participate
Here is what you need to know about eligibility for this trial. You can join if you are between 18 and 80 years old and can understand German. You must have a suspected or confirmed diagnosis of Alzheimer's, mild cognitive impairment, or depression with cognitive problems. You cannot join if you have acute suicidal thoughts, a history of psychotic or bipolar disorder, or recent stroke. Recent changes in psychiatric medication or current substance abuse are also reasons for exclusion. This trial is studying Alzheimer s Disease, Major Depressive Disorder (MDD), Mild Cognitive Impairment, Dementia, so participants generally need a confirmed diagnosis. The trial is currently accepting new participants.
What They're Measuring
The primary outcome measures how your pupil size changes during a memory task, which could show how well your brain is working and if it's declining. The specific primary outcome measures are: Task-evoked pupil dilation during N-Back (Baseline). 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 matters because new dementia treatments are emerging, making early and accurate detection of cognitive decline crucial for timely intervention. This research targets Alzheimer s Disease, Major Depressive Disorder (MDD), Mild Cognitive Impairment, Dementia, where improved treatment options are needed.
Investor Insight
This observational study could lead to a new, non-invasive tool for diagnosing and monitoring cognitive disorders, a large and growing market, with potential for early adoption given the unmet need.
Is This Trial Right for Me?
Ask your doctor if this VR eye-tracking test is suitable for you and how it compares to other cognitive tests. You will visit the research center multiple times over 6 months for VR eye-tracking and cognitive tests. The tests involve looking at a screen in a VR headset while performing simple tasks like looking at lights or remembering information. 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: 140 participants
Primary Outcomes
- Task-evoked pupil dilation during N-Back (Baseline)
Secondary Outcomes
- Resting-state pupil dynamics (Baseline, 3 months, 6 months.)
- Reward-task pupil response (Baseline, 3 months, 6 months.)
- N-back behavioral performance (Baseline, 3 months, 6 months.)
- Montreal Cognitive Assessment (MoCA) (Baseline, 3 months, 6 months.)
- CERAD cognitive battery (CERAD-Plus), norm-referenced z-scores (Baseline, 6 months.)
Full Eligibility Criteria
Inclusion Criteria: 1. Written informed consent. 2. Age 18-80 years. 3. Ability to read and understand German. 4. For patient cohorts: suspected or confirmed diagnosis of AD/MCI/depressive disorder with cognitive impairment according to clinical assessment and routine documentation. Exclusion Criteria: 1. Acute suicidality (e.g. BDI suicidality item \> 1). 2. Change of psychotropic medication within the last 4 weeks. 3. Lifetime psychotic disorder (ICD-10 F20-29). 4. Lack of capacity to consent. 5. Lifetime bipolar disorder (ICD-10 F31). 6. Acute substance abuse or harmful use of alcohol or other psychoactive substances. 7. Parkinson's syndrome (ICD-10 G20). 8. Multiple sclerosis (ICD-10 G35). 9. Stroke within the last 12 months.
Trial Locations
- Max Planck Institute of Psychiatry, München, Bavaria, Germany
Frequently Asked Questions
What is clinical trial NCT07402356?
NCT07402356 is a Not Applicable OBSERVATIONAL study titled "VR Pupillometry in Cognitive Impairment." It is currently recruiting and is sponsored by Max-Planck-Institute of Psychiatry. The trial targets enrollment of 140 participants.
What conditions does NCT07402356 study?
This trial investigates treatments for Alzheimer s Disease, Major Depressive Disorder (MDD), Mild Cognitive Impairment, Dementia. The primary condition under study is Alzheimer s Disease.
What does Not Applicable mean for NCT07402356?
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 NCT07402356?
This trial is currently "Recruiting." It started on 2025-05-01. The estimated completion date is 2027-12-31.
Who is sponsoring NCT07402356?
NCT07402356 is sponsored by Max-Planck-Institute of Psychiatry. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT07402356?
The trial aims to enroll 140 participants. The trial is currently recruiting and accepting new participants.
How is NCT07402356 designed?
This is a observational study.
What are the primary outcomes being measured in NCT07402356?
The primary outcome measures are: Task-evoked pupil dilation during N-Back (Baseline). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT07402356 being conducted?
This trial is being conducted at 1 site, including München, Bavaria (Germany).
Where can I find official information about NCT07402356?
The official record for NCT07402356 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT07402356. This government database provides the most up-to-date and detailed information about the trial.
What is NCT07402356 testing in simple terms?
This study tests if a virtual reality (VR) eye-tracking test can detect early signs of cognitive decline. It is for adults aged 18-80 who have Alzheimer's disease, mild cognitive impairment, or depression with cognitive issues, as well as healthy individuals.
Why is this trial significant?
This trial matters because new dementia treatments are emerging, making early and accurate detection of cognitive decline crucial for timely intervention.
What are the potential risks of participating in NCT07402356?
Potential side effects are minimal and may include temporary eye strain or discomfort from the VR headset. The tests are non-invasive, but some participants might experience mild dizziness or disorientation from the VR experience. There's a small risk of discomfort if you have pre-existing eye conditions, though this will be assessed before participation. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT07402356?
Ask your doctor if this VR eye-tracking test is suitable for you and how it compares to other cognitive tests. You will visit the research center multiple times over 6 months for VR eye-tracking and cognitive tests. The tests involve looking at a screen in a VR headset while performing simple tasks like looking at lights or remembering information. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT07402356 signal from an investment perspective?
This observational study could lead to a new, non-invasive tool for diagnosing and monitoring cognitive disorders, a large and growing market, with potential for early adoption given the unmet need. 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 eye-tracking tests using VR and standard cognitive assessments over 6 months. 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.
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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.