Alzheimer Disease, Dementia With Lewy Bodies, Healthy Controls, Mild Cognitive Impairment, Neuro-Degenerative Diseases, Vascular Dementia
Conditions
Keywords
Biomarkers, Pupillometry, Actigraphy, Blood-based biomarkers
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.
Interventions
OTHERLong-term study
No intervention. Investigations: cognitive tests, blood samples, pupillometry, actigraphy, and FDG-PET/MR brain scan.
OTHERShort-term study
No intervention. Investigations: blood samples and pupillometry.
No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
Sponsors
Danish Dementia Research Centre
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
30 Years to 110 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Denmark
Outcome results
None listed