Alzheimer DiseaseTRACK-ADNCT05175664
Novel Diagnostic and Disease Stage Biomarkers in AD
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Danish Dementia Research Centre at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 30 to 110 years
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Neuro-Degenerative Diseases
- What is being tested?
- Long-term study, Short-term study and Cross-sectional study
- How many people
- 350 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2022to 1 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In the longitudinal study (1) the investigators will include 100 patients diagnosed with mild cognitive impairment due to Alzheimer's disease or diagnosed with mild to moderate Alzheimer's disease. In the short-term study (2) the investigators will include 40 patients who are under investigation of a neurodegenerative disease. In the cross-sectional study (3) the investigatorswill include 50 patients with Alzheimer's disease, 50 healthy controls without brain disease, and 100 patients with other forms of dementia (dementia with Lewy body, vascular dementia, normal pressure hydrocephalus, frontotemporal dementia).
Who may be able to join
- 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
Show all 18Show fewer
- 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
Who cannot join
- 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:
Show all 20Show fewer
- 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:
- 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
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: TRacking Alzheimer´s Disease: a Study of Disease trajeCtory and Development of Diagnostic and Disease Stage biomarKers in AD (TRACK-AD)
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.
Read the 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.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Neuro-Degenerative Diseases, Vascular Dementia, Dementia With Lewy Bodies, Healthy Controls
- Being tested
- Long-term study, Short-term study, Cross-sectional study
- Keywords
- Biomarkers, Pupillometry, Actigraphy, Blood-based biomarkers
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Vascular, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Long-term studyOther
No intervention. Investigations: cognitive tests, blood samples, pupillometry, actigraphy, and FDG-PET/MR brain scan.
Short-term studyOther
No intervention. Investigations: blood samples and pupillometry.
Cross-sectional studyOther
No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
| Study group | Role | What they receive |
|---|---|---|
| MCI | Patients suffering from mild cognitive impairment (MCI) due to Alzheimer's disease. Receives: Other: Long-term study | |
| AD | Patients diagnosed with mild to moderate Alzheimer's disease (AD) Receives: Other: Long-term study; Other: Cross-sectional study | |
| NDD | Patients under investigation of a neurodegenerative disease (NDD) Receives: Other: Short-term study | |
| DLB | Patients diagnosed with Dementia with Lewy Bodies (DLB) Receives: Other: Cross-sectional study | |
| VaD | Patients with vascular dementia (VaD) Receives: Other: Cross-sectional study | |
| FTD | Frontotemporal dementia (FTD) Receives: Other: Cross-sectional study | |
| NPH | Normal pressure hydrocephalus (NPH) Receives: Other: Cross-sectional study | |
| Healthy Controls | Healthy Controls without brain disease Receives: Other: Cross-sectional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Two years
Secondary outcomes (3)
Changes in MMSE
Mini Mental Status Examination (MMSE), used to test global cognitive function
Measured: Two years
Changes in MR brain scan
Magnetic Resonance Imaging (MR), used to asses changes in volumetric measurements
Measured: 12 months
FDG-PET brain scan
Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) of the brain, used to asses changes in brain metabolism
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start1 Jan 2022
- Primary completion1 Dec 2024
- Study completion1 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 350 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Dementia Research Centre
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Frederikke Kragh Clemmensen, MD, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, DenmarkMathias Holsey Gramkow, MD, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, DenmarkKristian Steen Frederiksen, MD, PhD, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, DenmarkSteen Gregers Hasselbalch, DMSc, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, DenmarkAnja Hviid Simonsen, MSc Pharm PhD, Principal investigator, Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05175664
- Sponsor's protocol ID
- H-21040317
- Acronym
- TRACK-AD
- Status last verified
- May 2025
- First submitted
- 1 Dec 2021
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clemmensen FK, Gramkow MH, Gonzalez-Ortiz F, Benedet AL, Tan K, Traichel W, Lindberg U, Henriksen OM, Zetterberg H, Blennow K, Law I, Simonsen AH, Frederiksen KS, Hasselbalch SG. Prognostic value of plasma biomarkers in early Alzheimer's disease: a longitudinal clinical and neuroimaging study. Alzheimers Res Ther. 2025 Nov 12;17(1):243. doi: 10.1186/s13195-025-01892-7.
PubMed 41225647Clemmensen FK, Gramkow MH, Simonsen AH, Ashton NJ, Huber H, Blennow K, Zetterberg H, Waldemar G, Hasselbalch SG, Frederiksen KS. Short-term variability of Alzheimer's disease plasma biomarkers in a mixed memory clinic cohort. Alzheimers Res Ther. 2025 Jan 21;17(1):26. doi: 10.1186/s13195-024-01658-7.
PubMed 39838483
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRacking Alzheimer´s Disease: a Study of Disease trajeCtory and Development of Diagnostic and Disease Stage biomarKers in AD (TRACK-AD)
- ClinicalTrials.gov ID
- NCT05175664
- Acronym / sponsor ID
- TRACK-AD / H-21040317
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment, Neuro-Degenerative Diseases, Vascular Dementia, Dementia With Lewy Bodies, Healthy Controls
- Keywords
- Biomarkers, Pupillometry, Actigraphy, Blood-based biomarkers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 350 participants (actual)
- Lead sponsor
- Danish Dementia Research CentreResearch network
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 1 Dec 2024 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| MCI | – | Other: Long-term studyPatients suffering from mild cognitive impairment (MCI) due to Alzheimer's disease. |
| AD | – | Other: Long-term study, Other: Cross-sectional studyPatients diagnosed with mild to moderate Alzheimer's disease (AD) |
| NDD | – | Other: Short-term studyPatients under investigation of a neurodegenerative disease (NDD) |
| DLB | – | Other: Cross-sectional studyPatients diagnosed with Dementia with Lewy Bodies (DLB) |
| VaD | – | Other: Cross-sectional studyPatients with vascular dementia (VaD) |
| FTD | – | Other: Cross-sectional studyFrontotemporal dementia (FTD) |
| NPH | – | Other: Cross-sectional studyNormal pressure hydrocephalus (NPH) |
| Healthy Controls | – | Other: Cross-sectional studyHealthy Controls without brain disease |
Who may qualify
- Ages
- 30 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In the longitudinal study (1) the investigators will include 100 patients diagnosed with mild cognitive impairment due to Alzheimer's disease or diagnosed with mild to moderate Alzheimer's disease. In the short-term study (2) the investigators will include 40 patients who are under investigation of a neurodegenerative disease. In the cross-sectional study (3) the investigatorswill include 50 patients with Alzheimer's disease, 50 healthy controls without brain disease, and 100 patients with other forms of dementia (dementia with Lewy body, vascular dementia, normal pressure hydrocephalus, frontotemporal dementia).
Key inclusion criteria (18 listed)
- 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
Key exclusion criteria (20 listed)
- Short-term study:
- Cross-sectional study:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Long-term studyNo intervention. Investigations: cognitive tests, blood samples, pupillometry, actigraphy, and FDG-PET/MR brain scan. | Other | AD, MCI |
| Short-term studyNo intervention. Investigations: blood samples and pupillometry. | Other | NDD |
| Cross-sectional studyNo intervention. Investigations: cognitive tests, pupillometry and actigraphy. | Other | AD, DLB, FTD, Healthy Controls, NPH, VaD |
Primary outcome
Changes in CDR
Time frame: 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).
3 secondary outcomes
Changes in MMSE
Time frame: Two years
Changes in MR brain scan
Time frame: 12 months
FDG-PET brain scan
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Derived from this study: PubMed 41225647Clemmensen FK, Gramkow MH, Gonzalez-Ortiz F, Benedet AL, Tan K, Traichel W, Lindberg U, Henriksen OM, Zetterberg H, Blennow K, Law I, Simonsen AH, Frederiksen KS, Hasselbalch SG. Prognostic value of plasma biomarkers in early Alzheimer's disease: a longitudinal clinical and neuroimaging study. Alzheimers Res Ther. 2025 Nov 12;17(1):243. doi: 10.1186/s13195-025-01892-7.
- Derived from this study: PubMed 39838483Clemmensen FK, Gramkow MH, Simonsen AH, Ashton NJ, Huber H, Blennow K, Zetterberg H, Waldemar G, Hasselbalch SG, Frederiksen KS. Short-term variability of Alzheimer's disease plasma biomarkers in a mixed memory clinic cohort. Alzheimers Res Ther. 2025 Jan 21;17(1):26. doi: 10.1186/s13195-024-01658-7.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederikke Kragh Clemmensen, MD principal investigator
Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
Mathias Holsey Gramkow, MD principal investigator
Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
Kristian Steen Frederiksen, MD, PhD principal investigator
Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease and Mild Cognitive Impairment, run by Danish Dementia Research Centre at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in CDR (time frame: Two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05175664, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.