Healthy Test PersonsNCT03290040
Identification of Predictors for Early Cognitive Decline in Men
An observational study of Healthy Test Persons and Mild Cognitive Impairment, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The research program explores how aging influences brain function in test-persons from a Danish birth cohort of men born in 1953. Read more about this study
- Who is it for?
- Ages 60 years and older, men only
- Conditions the study is for
- Healthy Test Persons, Mild Cognitive Impairment, Alzheimer Disease
- How many people
- 564 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Dec 2022
- 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 60 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Danish birth cohort of 11.532 men born in 1953 in the Metropolitan area of Copenhagen. Only men who have participated in the Copenhagen Aging and Midlife Biobank project are considered. Persons from the Memory Clinic at Herlev Hospital will be included in the period 2020-2021. These individuals are diagnosed with either MCI or AD.
Who may be able to join
- Participants who have participated in the Metropolit study and the Copenhagen Aging and Midlife Biobank project
- Participants who have been informed about the project and who have signed the informed consent form
Who cannot join
- Persons who have been asked to participate in the past and have rejected
- Reduced ability to understand project information
- Reduced ability to complete the examinations
- Abuse of alcohol, psychedelic drugs or habit-forming drugs
- Certain neurological disorders
- Certain neurological, mental or psychiatric diagnoses
Show all 11Show fewer
- Certain depressive diseases
- Former traumatic brain injury
- Contraindication for MR scanning
- Pathological MR result
- Persons that do not like to be informed about a possible pathological result
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Clinical Neurophysiology, Department of Clinical Biochemistry and Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet - Glostrup
Glostrup Municipality, 2600
About this study
Official title: Identification of Predictors for Early Cognitive Decline: a Longitudinal Cohort Study in Men Born in 1953
The research program explores how aging influences brain function in test-persons from a Danish birth cohort of men born in 1953.
Read the detailed description
The research program explores how ageing influences brain function in healthy test-persons from a Danish birth cohort of men born in 1953 in the Metropolitan area of Copenhagen. These test-persons are divided into two groups based on performance in cognitive tests at late midlife compared to young adulthood; Positive expected performance and negative expected performance and sampled from a birth cohort of 11.532 men.
Additionally, persons diagnosed with either MCI or AD will be included from the Memory Clinic at Herlev Hospital.
Researchers aim to identify factors earlier in life that affects or predict changes in cognitive function, specifically of cognitive decline in order to predict healthy vs unhealthy cognitive ageing, including progression to possible dementia. The objective is to be able to predict cognitive decline in ageing.
During the years of data collection, approximately 550 participants will be included and examined.
The examinations include:
- Cognitive test including Cambridge Neuropsychological test automated Battery (CANTAB);
- Sleep
- Life events
- Depression questionnaire
- Blood sample analysis including functional analyses of mitochondria and gene analyses such as genome scanning, SNP analysis
- ApoE ε-type
- Structural and functional changes in the brain measured with magnetic resonance (fMRI)
- Electroencephalography (EEG) recordings of electrical activity and visual attention
- PET-scan (Amyloid and FDG)
The results from these studies will hopefully point to new avenues for intervention in order to change the course of brain ageing
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Metropolit Cohort | Danish birth cohort of men born in 1953 in the Metropolitan area of Copenhagen. These test-persons are divided into two groups based on performance in cognitive tests at late midlife compared to young adulthood; Positive expected performance and negative expected performance and sampled from a birth cohort of 11.532 men. | |
| Herlev Hospital, Memory Clinic | Persons from the Memory Clinic at Herlev Hospital. These subjects are diagnosed with either MCI or AD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gamma band EEG power during evoked potentials correlates to cognitive decline
Visual and auditory evoked potentials are elicited in the brain using flickering visual stimuli and amplitude-modulated tones, respectively. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject, as well as other clinical cognitive tests sensitive to aging effects
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Alpha band EEG-power during evoked potentials correlates to cognitive decline
Visual evoked potentials are elicited in the brain using flickering visual stimulus. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject, as well as other clinical cognitive tests sensitive to aging effects
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Examination of how visual attention effects cognitive deterioration.
The accuracy of reporting shown isoluminant letters of the patient is compared to speed of processing (ms), IQ and short term memory function.
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Clarification of how processing speed (ms), short term memory and visual perceptive threshold effect cognitive capacity.
Relating brain states to attentional functions by linking visual event-related potentials measured with EEG to specific attentional functions derived from behavioural testing
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Changes in mitochondrial respiration as predictor of cognitive impairment
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Microstructural parameters, derived from diffusion tensor imaging as predictor of cognitive impairment
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between basal ganglia volumes and structure and cognitive functions
Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Basal ganglia volumes are based on automatic segmentation procedures. Basal ganglia microstructure and iron content will be estimated using quantitative susceptibility imaging
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between patterns of brain perfusion and patterns of cognitive function
Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Brain perfusion will be measured with arterial spin labeling, and the analysis performed using multivariate techniques
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between Subjective sleep quality and patterns of cognitive function
Cognitive functions are based on CANTAB as well as paper and pencil tests. Sleep quality is measured using the self-report questionnaire Pittsburgh Sleep quality Index (PSQI).
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Objective sleep measures: Sleep stages as determined by standard international scoring and quantitated measures using - spectral analysis from sleep EEG in relation to cognitive impairment
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Effects of demographic, social and health predictors on change in cognitive function from young adulthood to late midlife
Cognitive composite score (based on CANTAB, paper- and pencil tests)
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between daytime sleepiness and patterns of cognitive function
Cognitive functions are based on CANTAB as well as paper and pencil tests. Daytime sleepiness is measured using the Epworh Sleepiness Scale (ESS) questionnaire.
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
FDG - PET
FDG - PET scan uses a special radioactive glucose-analogue tracer which the body uptake similarly to normal glucose. This allows us to investigate how well an individual can uptake glucose in relevant brain areas and thereby how well they increase the metabolism and activity in these brain areas when stimulated.
With this method, we can see how the brain is working and detect any abnormalities.
Measured: This examination will be performed in 2020-2021.
PIB - PET
PIB - PET scan uses special radioactive tracers that highlight amyloid protein plaques in the brain, which are a hallmark of Alzheimer's disease. This scanning will allow us to see the distribution of Amyloid plaques in the cohort and to test for correlation with cognitive decline.
Measured: This examination will be performed in 2020-2021.
Secondary outcomes (20)
Gamma band EEG power distribution across the scalp during simultaneous auditory and visual stimulation correlates to cognitive decline
Visual and auditory evoked potentials are elicited in the brain using a paradigm that presents a visual stimulus and an auditory stimulus simultaneously. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Change of source location of gamma band EEG power of visual evoked potentials correlates to cognitive decline
Visual evoked potentials are elicited in the brain using flickering visual stimulus. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject, as well as other clinical cognitive tests sensitive to aging effects
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
The investigators would like to describe how visual attention correlates with the background EEG recorded before the examination.
Linking functional effects of prestimulus alpha power measured by EEG to perception accuracy
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Change in levels of reactive oxygen species in PBMCs quantified by flow cytometry after application of dedicated fluorophores as predictor of cognitive impairment
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Change in levels of mitochondrial bioenergetics in PBMCs using the Seahorse XF24 extracellular flux analyser as predictor of cognitive impairment
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Change of levels of whole cell dNTP levels in PBMCs using polymerase extension assay and by quantification of tritiated nucleotides by scintillation counting as predictor of cognitive impairment
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Change of mutation frequency of mitochondrial DNA using deep sequencing as predictor of cognitive impairment
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Change of mtDNA copy number by qPCR as predictor of cognitive impairment
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between regional cortical thickness and cognitive parameters
Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Cortical thickness will be analysed using FreeSurfer or similar software, and the analysis performed using multivariate techniques
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between regional cortical surface and cognitive parameters
Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Cortical surface will be analysed using FreeSurfer or similar software, and the analysis performed using multivariate techniques
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between macrostructural parameters and candidate genes
Macrostructural parameters will be derived from segmentation of T1-weighted images. The statistical analysis will consider macrostructural parameters as a possible mediator of common genetic variants upon cognition. Candidate genes will be selected due to their relation to 1) cardiovascular function and disease 2) oxidative stress, longevity and ageing and 3) memory and intelligence.
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between microstructural parameters and candidate genes
Microstructural parameters will be derived from diffusion tensor imaging. The statistical analysis will consider microstructural parameters as a possible mediator of common genetic variants upon cognition. Candidate genes will be selected due to their relation to 1) cardiovascular function and disease 2) oxidative stress, longevity and ageing and 3) memory and intelligence.
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between macrostructural parameters and cognition
Macrostructural parameters will be derived from segmentation of T1-weighted images. Cognitive composite scores are based on CANTAB as well as paper and pencil test.
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between microstructural parameters and cognition
Microstructural parameters will be derived from diffusion tensor imaging. Cognitive composite scores are based on CANTAB as well as paper and pencil test.
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between cognition and candidate genes
Cognitive composite scores are based on CANTAB as well as paper and pencil test.Candidate genes will be selected due to their relation to 1) cardiovascular function and disease 2) oxidative stress, longevity and ageing and 3) memory and intelligence.
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between sleep stages and microstructural parameters.
Sleep stages will be determined by standard international scoring and quantitated measures using spectral analysis from sleep EEG. Microstructures will be measured with MRI.
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between sleep stages and regional volumes.
Sleep stages will be determined by standard international scoring and quantitated measures using spectral analysis from sleep EEG. Regional volumes will be measured with MRI.
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Autonomic activity as measured by electrocardiography determined from the polysomnography during wakefulness and sleep in relation to cognitive impairment
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Presence of REM Sleep muscle activity (REM sleep without atonia (RSWA), REM Behavior disorder(RBD)) in relation to cognitive impairment
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Cognitive correlates of cognitive change
Cognitive composite score (based on CANTAB, paper- and pencil tests)
Measured: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2017
- Study startJan 2015
- Primary completionMay 2022
- Study completionDec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Test PersonsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- 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
- 564 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, Herlev Hospital
- Responsible party
- Principal investigator, Martin Lauritzen, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Martin J Lauritzen, Prof, Principal investigator, Dept. of Clinical Neurophysiology, Rigshospitalet - GlostrupMartin J Lauritzen, Prof, Principal investigator, Dept. of Clinical Neurophysiology, Rigshospitalet - Glostrup, Neuronal Signalling Lab, Center for Neuroscience, and Center for Healthy aging, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03290040
- Sponsor's protocol ID
- H-1-2014-032
- Status last verified
- Nov 2023
- First submitted
- 18 Nov 2015
- Last updated
- 28 Nov 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Predictors for Early Cognitive Decline: a Longitudinal Cohort Study in Men Born in 1953
- ClinicalTrials.gov ID
- NCT03290040
- Acronym / sponsor ID
- H-1-2014-032
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 564 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- University of Copenhagen, Herlev Hospital
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2022 (actual)
- Study completion
- Dec 2022 (actual)
- First posted
- 21 Sep 2017 (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.
The research program explores how aging influences brain function in test-persons from a Danish birth cohort of men born in 1953.
Detailed description
The research program explores how ageing influences brain function in healthy test-persons from a Danish birth cohort of men born in 1953 in the Metropolitan area of Copenhagen. These test-persons are divided into two groups based on performance in cognitive tests at late midlife compared to young adulthood; Positive expected performance and negative expected performance and sampled from a birth cohort of 11.532 men.
Additionally, persons diagnosed with either MCI or AD will be included from the Memory Clinic at Herlev Hospital.
Researchers aim to identify factors earlier in life that affects or predict changes in cognitive function, specifically of cognitive decline in order to predict healthy vs unhealthy cognitive ageing, including progression to possible dementia. The objective is to be able to predict cognitive decline in ageing.
During the years of data collection, approximately 550 participants will be included and examined.
The examinations include:
- Cognitive test including Cambridge Neuropsychological test automated Battery (CANTAB);
- Sleep
- Life events
- Depression questionnaire
- Blood sample analysis including functional analyses of mitochondria and gene analyses such as genome scanning, SNP analysis
- ApoE ε-type
- Structural and functional changes in the brain measured with magnetic resonance (fMRI)
- Electroencephalography (EEG) recordings of electrical activity and visual attention
- PET-scan (Amyloid and FDG)
The results from these studies will hopefully point to new avenues for intervention in order to change the course of brain ageing
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metropolit Cohort | – | –Danish birth cohort of men born in 1953 in the Metropolitan area of Copenhagen. These test-persons are divided into two groups based on performance in cognitive tests at late midlife compared to young adulthood; Positive expected performance and negative expected performance and sampled from a birth cohort of 11.532 men. |
| Herlev Hospital, Memory Clinic | – | –Persons from the Memory Clinic at Herlev Hospital. These subjects are diagnosed with either MCI or AD. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Danish birth cohort of 11.532 men born in 1953 in the Metropolitan area of Copenhagen. Only men who have participated in the Copenhagen Aging and Midlife Biobank project are considered. Persons from the Memory Clinic at Herlev Hospital will be included in the period 2020-2021. These individuals are diagnosed with either MCI or AD.
Key inclusion criteria (2 listed)
- Participants who have participated in the Metropolit study and the Copenhagen Aging and Midlife Biobank project
- Participants who have been informed about the project and who have signed the informed consent form
Key exclusion criteria (11 listed)
- Persons who have been asked to participate in the past and have rejected
- Reduced ability to understand project information
- Reduced ability to complete the examinations
- Abuse of alcohol, psychedelic drugs or habit-forming drugs
- Certain neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Gamma band EEG power during evoked potentials correlates to cognitive decline
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Visual and auditory evoked potentials are elicited in the brain using flickering visual stimuli and amplitude-modulated tones, respectively. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject, as well as other clinical cognitive tests sensitive to aging effects
Alpha band EEG-power during evoked potentials correlates to cognitive decline
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Visual evoked potentials are elicited in the brain using flickering visual stimulus. The potentials are recorded through scalp electroencephalography (EEG), using a 64-channel EEG cap. A measure of cognitive decline is approximated using intelligence test scores collected at three distinct times in the lifespan of the subject, as well as other clinical cognitive tests sensitive to aging effects
Examination of how visual attention effects cognitive deterioration.
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
The accuracy of reporting shown isoluminant letters of the patient is compared to speed of processing (ms), IQ and short term memory function.
Clarification of how processing speed (ms), short term memory and visual perceptive threshold effect cognitive capacity.
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Relating brain states to attentional functions by linking visual event-related potentials measured with EEG to specific attentional functions derived from behavioural testing
Changes in mitochondrial respiration as predictor of cognitive impairment
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Microstructural parameters, derived from diffusion tensor imaging as predictor of cognitive impairment
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between basal ganglia volumes and structure and cognitive functions
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Basal ganglia volumes are based on automatic segmentation procedures. Basal ganglia microstructure and iron content will be estimated using quantitative susceptibility imaging
Correlation between patterns of brain perfusion and patterns of cognitive function
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Cognitive composite scores are based on CANTAB as well as paper and pencil tests. Brain perfusion will be measured with arterial spin labeling, and the analysis performed using multivariate techniques
Correlation between Subjective sleep quality and patterns of cognitive function
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Cognitive functions are based on CANTAB as well as paper and pencil tests. Sleep quality is measured using the self-report questionnaire Pittsburgh Sleep quality Index (PSQI).
Objective sleep measures: Sleep stages as determined by standard international scoring and quantitated measures using - spectral analysis from sleep EEG in relation to cognitive impairment
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Effects of demographic, social and health predictors on change in cognitive function from young adulthood to late midlife
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Cognitive composite score (based on CANTAB, paper- and pencil tests)
Correlation between daytime sleepiness and patterns of cognitive function
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Cognitive functions are based on CANTAB as well as paper and pencil tests. Daytime sleepiness is measured using the Epworh Sleepiness Scale (ESS) questionnaire.
FDG - PET
Time frame: This examination will be performed in 2020-2021.
FDG - PET scan uses a special radioactive glucose-analogue tracer which the body uptake similarly to normal glucose. This allows us to investigate how well an individual can uptake glucose in relevant brain areas and thereby how well they increase the metabolism and activity in these brain areas when stimulated. With this method, we can see how the brain is working and detect any abnormalities.
PIB - PET
Time frame: This examination will be performed in 2020-2021.
PIB - PET scan uses special radioactive tracers that highlight amyloid protein plaques in the brain, which are a hallmark of Alzheimer's disease. This scanning will allow us to see the distribution of Amyloid plaques in the cohort and to test for correlation with cognitive decline.
20 secondary outcomes
Gamma band EEG power distribution across the scalp during simultaneous auditory and visual stimulation correlates to cognitive decline
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Change of source location of gamma band EEG power of visual evoked potentials correlates to cognitive decline
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
The investigators would like to describe how visual attention correlates with the background EEG recorded before the examination.
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Change in levels of reactive oxygen species in PBMCs quantified by flow cytometry after application of dedicated fluorophores as predictor of cognitive impairment
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Change in levels of mitochondrial bioenergetics in PBMCs using the Seahorse XF24 extracellular flux analyser as predictor of cognitive impairment
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Change of levels of whole cell dNTP levels in PBMCs using polymerase extension assay and by quantification of tritiated nucleotides by scintillation counting as predictor of cognitive impairment
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Change of mutation frequency of mitochondrial DNA using deep sequencing as predictor of cognitive impairment
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Change of mtDNA copy number by qPCR as predictor of cognitive impairment
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between regional cortical thickness and cognitive parameters
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between regional cortical surface and cognitive parameters
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between macrostructural parameters and candidate genes
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between microstructural parameters and candidate genes
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between macrostructural parameters and cognition
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between microstructural parameters and cognition
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between cognition and candidate genes
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between sleep stages and microstructural parameters.
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Correlation between sleep stages and regional volumes.
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Autonomic activity as measured by electrocardiography determined from the polysomnography during wakefulness and sleep in relation to cognitive impairment
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Presence of REM Sleep muscle activity (REM sleep without atonia (RSWA), REM Behavior disorder(RBD)) in relation to cognitive impairment
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
Cognitive correlates of cognitive change
Time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years
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 28 Nov 2023.
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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.
Martin J Lauritzen, Prof principal investigator
Dept. of Clinical Neurophysiology, Rigshospitalet - Glostrup
Martin J Lauritzen, Prof principal investigator
Dept. of Clinical Neurophysiology, Rigshospitalet - Glostrup, Neuronal Signalling Lab, Center for Neuroscience, and Center for Healthy aging, University of Copenhagen
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 Healthy Test Persons and Mild Cognitive Impairment, run by Copenhagen University Hospital, Rigshospitalet 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 2 inclusion and 11 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 28 Nov 2023. 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?
Gamma band EEG power during evoked potentials correlates to cognitive decline (time frame: Participant is recruited and measured once at the examination day and reexamined every 5 year as long as the project is running and includes the measurement, expected up to 10 years). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Nov 2023.