TRACK-AD: Novel Diagnostic and Disease Stage Biomarkers in AD

Sponsor

Danish Dementia Research Centre (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05175664

Collaborator

(none)

350

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Mild Cognitive Impairment Neuro-Degenerative Diseases Vascular Dementia Dementia With Lewy Bodies Healthy Controls	Other: Long-term study Other: Short-term study Other: Cross-sectional study

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 Design

Study Type:

Observational

Anticipated Enrollment :

350 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2022

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
MCI Patients suffering from mild cognitive impairment (MCI) due to Alzheimer's disease.	Other: Long-term study No intervention. Investigations: cognitive tests, blood samples, pupillometry, actigraphy, and FDG-PET/MR brain scan.
AD Patients diagnosed with mild to moderate Alzheimer's disease (AD)	Other: Long-term study No intervention. Investigations: cognitive tests, blood samples, pupillometry, actigraphy, and FDG-PET/MR brain scan. Other: Cross-sectional study No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
NDD Patients under investigation of a neurodegenerative disease (NDD)	Other: Short-term study No intervention. Investigations: blood samples and pupillometry.
DLB Patients diagnosed with Dementia with Lewy Bodies (DLB)	Other: Cross-sectional study No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
VaD Patients with vascular dementia (VaD)	Other: Cross-sectional study No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
FTD Frontotemporal dementia (FTD)	Other: Cross-sectional study No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
NPH Normal pressure hydrocephalus (NPH)	Other: Cross-sectional study No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
Healthy Controls Healthy Controls without brain disease	Other: Cross-sectional study No intervention. Investigations: cognitive tests, pupillometry and actigraphy.

Outcome Measures

Primary Outcome Measures

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

Changes in MMSE [Two years]
Mini Mental Status Examination (MMSE), used to test global cognitive function
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 110 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Danish Dementia Research Centre

Investigators

Principal Investigator: Frederikke Kragh Clemmensen, MD, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
Principal Investigator: Mathias Holsey Gramkow, MD, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
Principal Investigator: Kristian Steen Frederiksen, MD, PhD, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
Principal Investigator: Steen Gregers Hasselbalch, DMSc, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
Principal Investigator: Anja Hviid Simonsen, MSc Pharm PhD, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark