Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
350 participants
OBSERVATIONAL
2022-01-01
2024-12-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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MCI
Patients suffering from mild cognitive impairment (MCI) due to Alzheimer's disease.
Long-term study
No intervention. Investigations: cognitive tests, blood samples, pupillometry, actigraphy, and FDG-PET/MR brain scan.
AD
Patients diagnosed with mild to moderate Alzheimer's disease (AD)
Long-term study
No intervention. Investigations: cognitive tests, blood samples, pupillometry, actigraphy, and FDG-PET/MR brain scan.
Cross-sectional study
No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
NDD
Patients under investigation of a neurodegenerative disease (NDD)
Short-term study
No intervention. Investigations: blood samples and pupillometry.
DLB
Patients diagnosed with Dementia with Lewy Bodies (DLB)
Cross-sectional study
No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
VaD
Patients with vascular dementia (VaD)
Cross-sectional study
No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
FTD
Frontotemporal dementia (FTD)
Cross-sectional study
No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
NPH
Normal pressure hydrocephalus (NPH)
Cross-sectional study
No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
Healthy Controls
Healthy Controls without brain disease
Cross-sectional study
No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
Interventions
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Long-term study
No intervention. Investigations: cognitive tests, blood samples, pupillometry, actigraphy, and FDG-PET/MR brain scan.
Short-term study
No intervention. Investigations: blood samples and pupillometry.
Cross-sectional study
No intervention. Investigations: cognitive tests, pupillometry and actigraphy.
Eligibility Criteria
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Inclusion 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
Exclusion Criteria
* 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:
* 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:
* 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
30 Years
110 Years
ALL
No
Sponsors
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Danish Dementia Research Centre
NETWORK
Responsible Party
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Principal Investigators
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Frederikke Kragh Clemmensen, MD
Role: PRINCIPAL_INVESTIGATOR
Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
Mathias Holsey Gramkow, MD
Role: PRINCIPAL_INVESTIGATOR
Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
Kristian Steen Frederiksen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
Steen Gregers Hasselbalch, DMSc
Role: PRINCIPAL_INVESTIGATOR
Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
Anja Hviid Simonsen, MSc Pharm PhD
Role: PRINCIPAL_INVESTIGATOR
Danish Dementia Research Centre, Rigshospitalet, Copenhagen, Denmark
Locations
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Danish Dementia Research Centre
Copenhagen, , Denmark
Countries
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References
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Clemmensen 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.
Other Identifiers
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H-21040317
Identifier Type: -
Identifier Source: org_study_id
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