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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05175664
Other study ID # H-21040317
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date January 1, 2022
Est. completion date January 1, 2025

Study information

Verified date December 2022
Source Danish Dementia Research Centre
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 350
Est. completion date January 1, 2025
Est. primary completion date January 1, 2025
Accepts healthy volunteers No
Gender All
Age group 30 Years to 110 Years
Eligibility 1. Longitudinal study: Inclusion criteria: - MCI due to AD, or mild or moderate AD dementia according to the National Institute on Aging and Alzheimer's Association (NIA-AA) diagnostic criteria - Caregiver willing to participate as an informant - MMSE >19 at inclusion - Brain FDG-PET/MRI or FDG/PET-CT - Able to cooperate to the investigations and give informed consent Exclusion criteria: - Other neurological or psychiatric illness that may affect neurofilament light (NfL) levels (severe neuropathy, multiple sclerosis (MS), stroke within the last 3 months, Wernicke encephalopathy) - Diagnosis of previous or current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis) within last 2 years - Excessive alcohol intake or substance abuse within the last 2 years - Ophthalmological disorders that may affect pupillometry - Participating in drug trials or other intervention trials 2. Short-term study: Inclusion criteria: - Patients under investigation of a neurodegenerative disease - MMSE >19 - Scheduled lumbar puncture/lumbar puncture performed within the last week prior to inclusion - Written consent form to the Danish Dementia Biobank - Able to cooperate to the investigations Exclusion criteria: - Other neurological or psychiatric illness that may affect NfL levels (severe neuropathy, MS, stroke within the last 3 months, Wernicke encephalopathy) - Excessive alcohol intake or substance abuse within the last 2 years - Ophthalmological disorders that may affect pupillometry - Participating in drug trials or other intervention trials 3. Cross-sectional study: Inclusion criteria - Patients: - A diagnosis of a dementia disorder - Caregiver willing to participate as an informant - MMSE >15 at inclusion - Able to cooperate to the investigations - Able to give informed consent Exclusion criteria - Patients: - Diagnosis of previous or current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis) within last 2 years - Excessive alcohol intake or substance abuse within the last 2 years - Other known brain disorder - Ophthalmological disorders that may affect pupillometry - Participating in drug trials or other intervention trials Inclusion criteria - Healthy Controls: - Able to cooperate to the investigations - Normal cognition - Age 50-90 year Exclusion criteria - Healthy Controls: - Diagnosis of previous or current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis) within last 2 years - Excessive alcohol intake or substance abuse within the last 2 years - Other known brain disorder - Ophthalmological disorders that may affect pupillometry

Study Design


Intervention

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

Locations

Country Name City State
Denmark Danish Dementia Research Centre Copenhagen

Sponsors (1)

Lead Sponsor Collaborator
Danish Dementia Research Centre

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in CDR 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). Two years
Secondary Changes in MMSE Mini Mental Status Examination (MMSE), used to test global cognitive function Two years
Secondary Changes in MR brain scan Magnetic Resonance Imaging (MR), used to asses changes in volumetric measurements 12 months
Secondary FDG-PET brain scan Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) of the brain, used to asses changes in brain metabolism 12 months
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