VR pupillometry to detect cognitive impairment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This prospective, single-center, repeated-measures study uses VR headsets with eye-tracking to record pupil responses alongside behavioral tests at baseline and at 3- and 6-month follow-ups. Adults (18–80 years) are assigned to one of four cohorts (n=35 each): biomarker-supported Alzheimer's disease, MCI without Alzheimer pathology, depressive disorder with cognitive impairment, or healthy controls. The protocol links pupil dynamics to locus coeruleus–noradrenergic arousal systems that are implicated early in Alzheimer pathology and may change with cognitive decline. Data will be used to compare pupil metrics across cohorts and over time to determine whether VR-based pupillometry offers a practical, noninvasive longitudinal biomarker.

Why it matters

Who can join: the full rules

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.

Where it's running

• Max Planck Institute of Psychiatry
  München, Bavaria, Germany Recruiting

Study contacts

• Principal investigator: Victor I. Spoormaker, PhD — Max-Planck-Institute of Psychiatry
• Study coordinator: Eva Vidovic, MD
• Email: eva_vidovic@psych.mpg.de
• Phone: 089-30622-1402

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.