NCT05175664Completed
Novel Diagnostic and Disease Stage Biomarkers in AD
TRacking Alzheimer´s Disease: a Study of Disease trajeCtory and Development of Diagnostic and Disease Stage biomarKers in AD (TRACK-AD)
Source: ClinicalTrials.gov · Last updated 13 May 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 350 (actual)
- First submitted
- 1 Dec 2021
- Start date
- 1 Jan 2022
- Primary completion date
- 1 Dec 2024
- Lead sponsor
- Danish Dementia Research Centre
- Diseases
- Lewy body dementia, Alzheimer disease
- NCT number
- NCT05175664
What you commit to
- Study type: Observational
- Participants enrolled: 350
- From 1 Jan 2022 to the primary completion date, 1 Dec 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Diagnosis of previous or current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis) within last 2 years
- Participating in drug trials or other intervention trials
- Participating in drug trials or other intervention trials
- Diagnosis of previous or current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis) within last 2 years
- Participating in drug trials or other intervention trials
- Diagnosis of previous or current major psychiatric disorder (schizophrenia, bipolar disorder, psychosis) within last 2 years
Other illness
- 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)
- Ophthalmological disorders that may affect pupillometry
- Other neurological or psychiatric illness that may affect NfL levels (severe neuropathy, MS, stroke within the last 3 months, Wernicke encephalopathy)
- Ophthalmological disorders that may affect pupillometry
- Other known brain disorder
- Ophthalmological disorders that may affect pupillometry
- Other known brain disorder
- Ophthalmological disorders that may affect pupillometry
Other
- Excessive alcohol intake or substance abuse within the last 2 years
- Short-term study:
- Excessive alcohol intake or substance abuse within the last 2 years
- Cross-sectional study:
- Excessive alcohol intake or substance abuse within the last 2 years
- Excessive alcohol intake or substance abuse within the last 2 years
Who the study is looking for
- 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
- 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
- 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
- Able to cooperate to the investigations
- Normal cognition
- Age 50-90 year
Criteria the registry did not label
- Longitudinal study:
Age in the registry: 30 years to 110 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Danish Dementia Research Centre Coordinator of this site? Confirm its status | Copenhagen | Denmark | Unknown status |
Related publications
- Prognostic value of plasma biomarkers in early Alzheimer's disease: a longitudinal clinical and neuroimaging study.Alzheimers Res Ther · 2025 · PMID 41225647
This page is information, not medical advice. Discuss any trial with your doctor.