Novel Diagnostic and Disease Stage Biomarkers in AD

Completed

• Conditions: Neuro-Degenerative Diseases; Healthy Controls; Alzheimer Disease; Mild Cognitive Impairment; Dementia With Lewy Bodies; Vascular Dementia
• Interventions: Other: Short-term study; Other: Long-term study; Other: Cross-sectional study

• Registration Number: NCT05175664
• Lead Sponsor: Danish Dementia Research Centre

Brief 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.

Study Timeline

• Study First Submitted: 2021-12-01
• Study Start: 2022-01-01
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-04
• Primary Completion: 2024-12-01
• Study Completion: 2024-12-01
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 350

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
NDD	Short-term study	Patients under investigation of a neurodegenerative disease (NDD)
AD	Long-term study	Patients diagnosed with mild to moderate Alzheimer's disease (AD)
AD	Cross-sectional study	Patients diagnosed with mild to moderate Alzheimer's disease (AD)
DLB	Cross-sectional study	Patients diagnosed with Dementia with Lewy Bodies (DLB)
VaD	Cross-sectional study	Patients with vascular dementia (VaD)
NPH	Cross-sectional study	Normal pressure hydrocephalus (NPH)
MCI	Long-term study	Patients suffering from mild cognitive impairment (MCI) due to Alzheimer's disease.
FTD	Cross-sectional study	Frontotemporal dementia (FTD)
Healthy Controls	Cross-sectional study	Healthy Controls without brain disease

Primary Outcome Measures

Name	Time	Method
Changes in CDR	Two years	Clinical Dementia Rating (CDR), a clinical tool for grading the relative severity of dementia with scores ranging from 0 (no impairment) to 3 (severe impairment).

Secondary Outcome Measures

Name	Time	Method
Changes in MR brain scan	12 months	Magnetic Resonance Imaging (MR), used to asses changes in volumetric measurements
FDG-PET brain scan	12 months	Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) of the brain, used to asses changes in brain metabolism
Changes in MMSE	Two years	Mini Mental Status Examination (MMSE), used to test global cognitive function

Trial Locations

Locations (1)

Danish Dementia Research Centre; 🇩🇰 Copenhagen, Denmark