RecruitingNCT07402356

VR Pupillometry in Cognitive Impairment

Task-evoked Pupillometry in AD, MCI, and Depression-Related Cognitive Impairment


Sponsor

Max-Planck-Institute of Psychiatry

Enrollment

140 participants

Start Date

May 1, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is using a virtual reality (VR) headset to measure how a person's pupils respond to light — a test called pupillometry. Researchers hope this can help detect or distinguish Alzheimer's disease, mild cognitive impairment (MCI), and depression-related cognitive problems. **You may be eligible if...** - You are between 18 and 80 years old - You can read and understand German - You have a suspected or confirmed diagnosis of Alzheimer's disease, mild cognitive impairment (MCI), or depression with memory/thinking difficulties **You may NOT be eligible if...** - You are currently experiencing thoughts of suicide - Your psychiatric medication has changed in the past 4 weeks - You have a history of psychosis or bipolar disorder - You have Parkinson's disease, multiple sclerosis, or had a stroke in the past 12 months - You are currently misusing alcohol or other substances Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Max Planck Institute of Psychiatry

München, Bavaria, Germany

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NCT07402356


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