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

Status: Recruiting
Location: See location...
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) healthy controls. Participants will undergo initial assessments at baseline and follow-up visit 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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
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• Written informed consent.

• Age 18-80 years.

• Ability to read and understand German.

• For patient cohorts: suspected or confirmed diagnosis of AD/MCI/depressive disorder with cognitive impairment according to clinical assessment and routine documentation.

Locations
Other Locations
Germany
Max Planck Institute of Psychiatry
RECRUITING
München
Contact Information
Primary
Eva Vidovic, MD
eva_vidovic@psych.mpg.de
089-30622-1402
Backup
Victor I. Spoormaker, PhD
ambulanz@psych.mpg.de
089-30622-1402
Time Frame
Start Date: 2025-05-01
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 140
Treatments
Alzheimer's Disease
Participants with complaints of cognitive deficits and a diagnosis of Alzheimer's disease (AD) supported by cerebrospinal fluid (CSF) biomarker profile, where available.
Mild Cognitive Impairment without Alzheimer's Disease
Participants with complaints of cognitive deficits meeting criteria for mild cognitive impairment without evidence of Alzheimer's disease (CSF biomarkers not consistent with AD).
Depressive Disorder With Cognitive Impairment
Participants with complaints of cognitive impairment and no evidence of Alzheimer's pathology; deficits most consistent with depressive disorder.
Healthy Controls
Age-matched healthy volunteers.
Related Therapeutic Areas
Sponsors
Leads: Max-Planck-Institute of Psychiatry

This content was sourced from clinicaltrials.gov