Monitoring of Brain Metabolites Using Proton and Deuterium MR Techniques

Eligibility criteria

General Inclusion Criteria (applicable to all groups):
1. Signed informed consent by the participant.
2. Ability to lie still in the MR scanner for at least one hour.
3. No current or lifetime history of drug or alcohol abuse.
4. No medications that interfere with cognition.
5. Normal or corrected-to-normal vision.
Disease-Specific Inclusion Criteria:
I. Type 2 Diabetes Patients group (PG-IV-2H-DM):
* Diagnosis of Type 2 diabetes according to the ADA classification.
* Treatment with lifestyle modification and/or non-insulin agents.
II. High-Grade Carotid Stenosis Patient Group (PG-IV-1H-HGCS):
* ≥50% stenosis of the carotid artery.
III. Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD) Patients (PG-IV-2H-AD/MCI):
* Diagnosis of Mild Cognitive Impairment (MCI) or early Alzheimer's disease (AD).
* Age range between 60-80 years.
* Fluent in German.
* Normal or corrected-to-normal vision and hearing.
* Ability to understand the research and provide informed consent.
Exclusion Criteria:
1. Under 18 years of age.
2. Claustrophobia.
3. Pregnancy or current state of lactation.
4. Active implants (e.g., pacemakers, neuro-stimulators).
5. Passive ferromagnetic implants.
6. Passive non-ferromagnetic metallic implants > 4 cm in a region covered by the active radio frequency (RF) coils.
7. Large tattoos inside a region covered by the active RF coils.
8. Known or suspected non-compliance.
9. Underweight \<30 kg body weight.
10. Body mass index (BMI) > 30.
11. Overweight >135 kg
12. Persons with extreme big head circumference or extreme astigmatism, which cannot be corrected by MR-compatible eyeglasses.
13. Persons not able to understand the informed consent form.
14. Not agreeing with the institute's policy to inform the subject on incidental findings discovered during the examination.
15. Visual and auditory acuity impairing neuropsychological testing (if relevant).
16. Diabetes or glucose intolerance according to WHO recommendations (excluded in the diabetes patient group).
17. Evidence of overt heart or renal disease.
18. Evidence of gastrointestinal tract disease.
19. Cognitive impairment (Mini-mental state examination score \<26/30, CDR score >0, memory complaints) (excluding AD, MCI groups).
20. Smoking.
21. Current or life-time drug or alcohol abuse
22. Untreated dyslipidemia, hypertension, or thyroid disease.
23. Antidepressant medications with anticholinergic properties.
24. Regular use of narcotic agents more than two doses per week within 4 weeks of screening.
25. Antiparkinsonian medications used within 4 weeks of screening.
26. Enrollment in any investigational drug studies within 4 weeks of screening.
27. Immunomodulating or oncological treatment.
28. Cardiac implantable electronic devices (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices.
29. Metallic intraocular foreign bodies: patients who have ever welded without eye protection or had facial injuries involving metal must have an orbit x-ray reviewed by a radiologist before MRI.
30. Implantable neurostimulation systems.
31. Cochlear implants/ear implants.
32. Drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps).
33. Catheters with metallic components (e.g., Swan-Ganz catheter).
34. Metallic fragments (e.g., bullets, shotgun pellets, shrapnel).
35. Cerebral artery aneurysm clips.
36. Magnetic dental implants.
37. Tissue expanders.
38. Artificial limbs.
39. Non-removable hearing aids.
40. Non-removable piercings.
41. Implantable cardiocerter defibrillators
42. Cardiac resynchronization therapy devices
43. Fever (temperature > 37.5°C measured prior to MRI).
44. Volunteers taking amphetamines or sedatives

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-03-25