TRACK-ADTRacking Alzheimer´s Disease: a Study of Disease trajeCtory and Development of Diagnostic and Disease Stage biomarKers in AD (TRACK-AD)
Data Collection
Collected from today forward - ProspectiveSynucleinopathies+22
+ Alzheimer Disease
+ Arterial Occlusive Diseases
Cohort
Tracking disease incidence in order to identify risk factors and understand disease progression over time.Summary
Study start date: January 1, 2022
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.350 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Cohort
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 30 to 110 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Danish Dementia Research Centre
Copenhagen, DenmarkOpen Danish Dementia Research Centre in Google Maps