Novel Diagnostic and Disease Stage Biomarkers in AD

Alzheimer Disease Clinical Trial

— TRACK-AD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05175664
• Other study ID #: H-21040317
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia
• Dementia With Lewy Bodies
• Dementia, Vascular
• Healthy Controls
• Lewy Body Disease
• Mild Cognitive Impairment
• Neurodegenerative Diseases
• Vascular Dementia

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