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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UNKNOWN
70 participants
OBSERVATIONAL
2017-02-01
2020-12-31
Brief Summary
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There are three aims in this project:
1. To investigate how the functional interaction between the locus coeruleus and other brain areas, in particular the medial temporal lobe areas, during memory processes (encoding, consolidation and retrieval) change with development of Alzheimer's disease.
2. To investigate associations between noradrenaline, memory performance and brain functioning. The investigators aim to investigate how acute noradrenalin levels change during the different memory processes and whether or not this is beneficial for performance. Furthermore, the investigators will investigate whether this interaction between noradrenalin, memory performance and brain functioning is different healthy older individuals (n =35) or patients with prodromal Alzheimer's disease (n =35).
3. To investigate the underlying neural network changes during transcutaneous vagus nerve stimulation. The investigators will focus on differences in functional connectivity between the locus coeruleus and the medial temporal lobe areas in healthy older individuals and prodromal Alzheimer's disease patients. An experimental condition will be compared with a sham condition in a pseudo-randomized cross-over design.
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Healthy older controls
7 Tesla MRI with memory task and non-invasive neurostimulation
7 Tesla MRI with memory task and non-invasive neurostimulation
This is not an intervention, we investigate the neural mechanisms
Prodromal Alzheimer's disease patients
7 Tesla MRI with memory task and non-invasive neurostimulation
7 Tesla MRI with memory task and non-invasive neurostimulation
This is not an intervention, we investigate the neural mechanisms
Interventions
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7 Tesla MRI with memory task and non-invasive neurostimulation
This is not an intervention, we investigate the neural mechanisms
Eligibility Criteria
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Inclusion Criteria
* diagnosis of prodromal Alzheimer's disease based on the latest research criteria (clinical assessment at the memory clinic : presence of at least a memory impairment, memory complaints expressed by the patient or informant, no problems in daily life functioning, no dementia and presence of biomarkers
* Clinical Dementia Rating score of 0.5 (
* Mini-Mental State Examination (MMSE) ≥ 23 and being mentally competent (in general, individuals with a MMSE ≥ 18 are considered mentally competent)
* Age: between 60 and 85 years old
* 50% female
* Right-handedness
* Average level of education
* Informed consent before participation in the study
For the healthy older individuals:
* Average neuropsychological test results, in accordance with normative data, corrected for age, education and gender
* No substantial memory complaints (according to the participant)
* Age: between 60 and 85 years old
* 50% female
* Right-handedness
* Average level of education
* Informed consent before participation in the study
Exclusion Criteria
* Psychoactive medication use
* Abuse of alcohol and drugs
* Cognitive impairment due to alcohol/drug abuse or abuse of other substances
* Past or present psychiatric or neurological disorders (major depression, schizophrenia, bipolar disorder, psychotic disorder (or treatment for it), epilepsy, stroke, Parkinson's disease, multiple sclerosis, brain surgery, brain trauma, electroshock therapy, kidney dialysis, Menière's disease, brain infections)
* Major vascular disorders (e.g. stroke)
* Heart diseases or pacemakers
* Contraindications for scanning (e.g. brain surgery, cardiac pacemaker, metal implants, claustrophobia, body tattoos)
60 Years
85 Years
ALL
Yes
Sponsors
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Netherlands Organisation for Scientific Research
OTHER_GOV
Maastricht University Medical Center
OTHER
Responsible Party
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Principal Investigators
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Frans Verhey, Prof
Role: STUDY_DIRECTOR
Maastricht University Medical Centre
Locations
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Maastricht University
Maastricht, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Heidi IL Jacobs, PhD
Role: primary
Other Identifiers
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NL51297.068.14
Identifier Type: -
Identifier Source: org_study_id
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