Alzheimer Disease, Early OnsetNCT04427436
Novel Dementia Biomarkers
An observational study of Alzheimer Disease, Early Onset, run by German Center for Neurodegenerative Diseases (DZNE).
Trial summary
The study will investigate structural and functional characteristics of the brain of dementia patients compared to healthy controls in order to get a better insight into importance of early biomarkers for the diagnosis of Alzheimer's dementia. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Early Onset
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 31 Dec 2021
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients aged between 50 and 80 years will be recruited from the memory clinic at the Department of Neurology of the Otto von Guericke University Clinic, Magdeburg, Germany. The diagnosis of MCI/AD will be established by experienced neurologists of the memory clinic according to standardised criteria. Control participants will be matched by education, age and gender. These will be recruited through advertisement.
Who may be able to join
- Clinically diagnosed MCI patients and matched healthy controls
Who cannot join
- Metal in body and tatoos;
- Other chronic systemic neurological, cardiologic, metabolic or musculo-skeletal diseases which have been proven to influence the outcome variables
- Alcohol abuse
- Colour blindness
- Pregnancy
- Surgery in the last 6 months
- Uncorrected vision
About this study
Official title: Investigating the Potential of Novel Dementia Biomarkers - an MRI, fNIRS and EEG Study
The study will investigate structural and functional characteristics of the brain of dementia patients compared to healthy controls in order to get a better insight into importance of early biomarkers for the diagnosis of Alzheimer's dementia. The methods for obtaining biomarkers incude magnetic resonance imaging (MRI), near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), electrocardiography (ECG) and neurophyshological assessments. Special parameters are being studied that have already been shown to detect changes in the early stages of Alzheimer's dementia.
- Conditions
- Alzheimer Disease, Early Onset
- Being tested
- No Intervention
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No InterventionOther
No Intervention
| Study group | Role | What they receive |
|---|---|---|
| Patients | Mild Cognitive Impairment (clinical determination) Receives: Other: No Intervention | |
| Control | Healthy Elderly Receives: Other: No Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locus Coeruleus (LC) Intensity
LC-intensity can be assesed with specific MRI sequences (TSE MRI-Sequence (see Dordevic et al, 2017))
Measured: 15 minutes
Volume of brain regions
VBM (voxel-based morphometry)
Measured: 30 minutes
fNIRS-based change in oxyhemoglobin and deoxyhemoglobin
In response to each task there is a hemodynamic response, which can be measured by fNIRS. In particular, fNIRS measures changes in blood oxy- and deoxy-hemoglobin.
Measured: 1 hour
Event-related-potential (ERP) waveforms: negative deflections (N100, N300) and positive deflections (P100, P300)
Voltages generated in the brain structures in response to specific events (Event-related potentials (ERPs))
Measured: 1 hour
Heart Rate Variability (HRV)
ECG-based variability measures in R-R intervals, both in rest abd during tasks
Measured: 1 hour
Score on CERAD-Plus
Cognitive performance measure in points, with a higher score meaning better performance
Measured: 30 minutes
Error-rate on Stroop-test
Test of executive functions, higher error-rate means worse performance
Measured: 10 minutes
Error-rate on N-Back-test
Working memory test, higher error-rate means worse performance
Measured: 10 minutes
Performance on verbal fluency test
Test of verbal fluency, more words spoken means a better score
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start1 Jul 2020 (estimated)
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease, Early OnsetStudies 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
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)
- Sponsor type
- University, hospital or other
- Collaborators
- Otto-von-Guericke University Magdeburg
- Responsible party
- Principal investigator, Notger Müller, German Center for Neurodegenerative Diseases (DZNE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04427436
- Sponsor's protocol ID
- MD070
- Status last verified
- Jun 2020
- First submitted
- 14 May 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Grassler B, Herold F, Dordevic M, Gujar TA, Darius S, Bockelmann I, Muller NG, Hokelmann A. Multimodal measurement approach to identify individuals with mild cognitive impairment: study protocol for a cross-sectional trial. BMJ Open. 2021 May 25;11(5):e046879. doi: 10.1136/bmjopen-2020-046879.
PubMed 34035103
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Potential of Novel Dementia Biomarkers - an MRI, fNIRS and EEG Study
- ClinicalTrials.gov ID
- NCT04427436
- Acronym / sponsor ID
- MD070
- Conditions
- Alzheimer Disease, Early Onset
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- German Center for Neurodegenerative Diseases (DZNE)University, hospital or other
- Collaborators
- Otto-von-Guericke University Magdeburg
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 11 Jun 2020 (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 study will investigate structural and functional characteristics of the brain of dementia patients compared to healthy controls in order to get a better insight into importance of early biomarkers for the diagnosis of Alzheimer's dementia. The methods for obtaining biomarkers incude magnetic resonance imaging (MRI), near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), electrocardiography (ECG) and neurophyshological assessments. Special parameters are being studied that have already been shown to detect changes in the early stages of Alzheimer's dementia.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: No InterventionMild Cognitive Impairment (clinical determination) |
| Control | – | Other: No InterventionHealthy Elderly |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged between 50 and 80 years will be recruited from the memory clinic at the Department of Neurology of the Otto von Guericke University Clinic, Magdeburg, Germany. The diagnosis of MCI/AD will be established by experienced neurologists of the memory clinic according to standardised criteria. Control participants will be matched by education, age and gender. These will be recruited through advertisement.
Key inclusion criteria (1 listed)
- Clinically diagnosed MCI patients and matched healthy controls
Key exclusion criteria (7 listed)
- Metal in body and tatoos;
- Other chronic systemic neurological, cardiologic, metabolic or musculo-skeletal diseases which have been proven to influence the outcome variables
- Alcohol abuse
- Colour blindness
- Pregnancy
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 |
|---|---|---|
| No InterventionNo Intervention | Other | Control, Patients |
Primary outcome
Locus Coeruleus (LC) Intensity
Time frame: 15 minutes
LC-intensity can be assesed with specific MRI sequences (TSE MRI-Sequence (see Dordevic et al, 2017))
Volume of brain regions
Time frame: 30 minutes
VBM (voxel-based morphometry)
fNIRS-based change in oxyhemoglobin and deoxyhemoglobin
Time frame: 1 hour
In response to each task there is a hemodynamic response, which can be measured by fNIRS. In particular, fNIRS measures changes in blood oxy- and deoxy-hemoglobin.
Event-related-potential (ERP) waveforms: negative deflections (N100, N300) and positive deflections (P100, P300)
Time frame: 1 hour
Voltages generated in the brain structures in response to specific events (Event-related potentials (ERPs))
Heart Rate Variability (HRV)
Time frame: 1 hour
ECG-based variability measures in R-R intervals, both in rest abd during tasks
Score on CERAD-Plus
Time frame: 30 minutes
Cognitive performance measure in points, with a higher score meaning better performance
Error-rate on Stroop-test
Time frame: 10 minutes
Test of executive functions, higher error-rate means worse performance
Error-rate on N-Back-test
Time frame: 10 minutes
Working memory test, higher error-rate means worse performance
Performance on verbal fluency test
Time frame: 10 minutes
Test of verbal fluency, more words spoken means a better score
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Derived from this study: PubMed 34035103Grassler B, Herold F, Dordevic M, Gujar TA, Darius S, Bockelmann I, Muller NG, Hokelmann A. Multimodal measurement approach to identify individuals with mild cognitive impairment: study protocol for a cross-sectional trial. BMJ Open. 2021 May 25;11(5):e046879. doi: 10.1136/bmjopen-2020-046879.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, Early Onset, run by German Center for Neurodegenerative Diseases (DZNE).
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 1 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Locus Coeruleus (LC) Intensity (time frame: 15 minutes). The study lists 9 primary outcomes in all. 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 NCT04427436, which also lists 1 linked publication.
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 11 Jun 2020.