NCT05175664

Novel Diagnostic and Disease Stage Biomarkers in AD

TRacking Alzheimer´s Disease: a Study of Disease trajeCtory and Development of Diagnostic and Disease Stage biomarKers in AD (TRACK-AD)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 350 (actual)
• Sponsor: Danish Dementia Research Centre · Network
• Sex: All
• Age: 30 Years – 110 Years
• Healthy volunteers: Not accepted

Summary

This study will investigate the efficacy of novel biomarkers, namely blood-based biomarkers, pupillometry and actigraphy to track and predict progression of Alzheimer's disease (AD). Furthermore, the study will investigate the diagnostic value of pupillometry and actigraphy for AD.

Detailed description

This study consist of three sub-studies. In study 1, participants diagnosed with mild cognitive impairment due to AD or mild to moderate AD will be followed for up to 24 months with repeated blood samples, pupillometry, actigraphy, cognitive tests and a control brain scan. In study 2, patients under investigation of a neurodegenerative disease who have a planned lumbar puncture in the Memory clinic will be invited to this study. Participants will undergo pupillometry and blood samples two times approximately one and four weeks after the lumbar puncture. In study 3, participants with a dementia diagnosis will undergo pupillometry and actigraphy at a single visit.

Conditions

• Alzheimer Disease
• Mild Cognitive Impairment
• Neuro-Degenerative Diseases
• Vascular Dementia
• Dementia With Lewy Bodies
• Healthy Controls

Interventions

Type	Name	Description
OTHER	Long-term study	No intervention. Investigations: cognitive tests, blood samples, pupillometry, actigraphy, and FDG-PET/MR brain scan.
OTHER	Short-term study	No intervention. Investigations: blood samples and pupillometry.
OTHER	Cross-sectional study	No intervention. Investigations: cognitive tests, pupillometry and actigraphy.

Timeline

• Start date: 2022-01-01
• Primary completion: 2024-12-01
• Completion: 2024-12-01
• First posted: 2022-01-04
• Last updated: 2025-05-13

Locations

1 site across 1 country: Denmark