Monitoring of Brain Metabolites Using Proton and Deuterium MR Techniques

Launched by INSEL GRUPPE AG, UNIVERSITY HOSPITAL BERN · Nov 25, 2024

Keywords

ClinConnect Summary

This clinical trial is focused on developing new imaging techniques to monitor brain metabolism, which refers to how the brain uses energy and nutrients. Researchers aim to create advanced MRI scans that can help identify changes in brain activity related to aging and various brain disorders, such as Alzheimer's disease, diabetes, and mild cognitive impairment. The study will take place in four phases, starting with testing the imaging methods on healthy volunteers and then applying them to different patient groups to see how these brain changes differ among people with specific conditions.

To participate in the trial, individuals must be between 18 and 80 years old and provide informed consent. Eligible participants should not have a history of substance abuse, must be able to remain still in the MRI machine, and have normal or corrected vision. Patients with conditions like Type 2 diabetes, mild cognitive impairment, or high-grade carotid stenosis may also qualify. Throughout the trial, participants can expect to undergo MRI scans that will help researchers gather valuable information about brain health, potentially leading to better understanding and treatment options in the future.

Gender

ALL

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