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Completed

NCT Number: NCT05175664

Novel Diagnostic and Disease Stage Biomarkers in 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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Long-term study

Other

No intervention. Investigations: cognitive tests, blood samples, pupillometry, actigraphy, and FDG-PET/MR brain scan.

Short-term study

Other

No intervention. Investigations: blood samples and pupillometry.

Cross-sectional study

Other

No intervention. Investigations: cognitive tests, pupillometry and actigraphy.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Changes in MMSE

    Time frame: Two years

    Mini Mental Status Examination (MMSE), used to test global cognitive function

  2. Changes in MR brain scan

    Time frame: 12 months

    Magnetic Resonance Imaging (MR), used to asses changes in volumetric measurements

  3. FDG-PET brain scan

    Time frame: 12 months

    Fluorodeoxyglucose (FDG)-Positron Emission Tomography (PET) of the brain, used to asses changes in brain metabolism

Sponsors and collaborators

Lead sponsor

Danish Dementia Research Centre

Network

Registry information

Official study title

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

Acronym: TRACK-AD

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 4, 2022
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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