VR Pupillometry in Cognitive Impairment
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 co
| Condition(s) | Alzheimer s Disease, Major Depressive Disorder (MDD), Mild Cognitive Impairment, Dementia |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| 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) health |
| Who can participate | 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. |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Accepts healthy volunteers | Yes |
| Lead sponsor | Max-Planck-Institute of Psychiatry |
| Locations | München, Bavaria, Germany |
| Start date | 2025-05-01 |
| NCT ID | NCT07402356 |
| Official listing | https://clinicaltrials.gov/study/NCT07402356 |