Evaluating a new PET imaging agent for brain conditions

PET Imaging Evaluation of [11C]SY08

This study is testing a new imaging agent to see if it can help detect certain brain changes in people with Parkinson's disease, Multiple System Atrophy, and Dementia with Lewy Bodies, as well as in healthy individuals.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 50 Years to 80 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Drugs / interventions: radiation
• Locations: 1 site (Charlestown, Massachusetts)
• Trial ID: NCT06098612 on ClinicalTrials.gov

What this trial studies

This research aims to assess the effectiveness of the PET radiotracer [11C]SY08 in detecting aggregated alpha synuclein in the brains of individuals with Parkinson's disease, Multiple System Atrophy, and Dementia with Lewy Bodies, as well as in healthy controls. The study will involve administering an intravenous injection of [11C]SY08 and conducting PET imaging to analyze its brain uptake, distribution, and kinetics. Additionally, the study will evaluate the human dosimetry of [11C]SY08 in healthy participants. The findings could enhance understanding of these neurodegenerative conditions and improve diagnostic methods.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 50-80 with a diagnosis of Parkinson's disease, Multiple System Atrophy, or Dementia with Lewy Bodies, as well as healthy controls.

Not a fit: Patients who are not fluent in English or those outside the age range of 50-80 may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved diagnostic imaging techniques for neurodegenerative diseases associated with alpha synuclein aggregates.

How similar studies have performed: While this approach is innovative, similar studies using PET imaging for neurodegenerative diseases have shown promise in the past.

Eligibility criteria

Inclusion Criteria:

* General Inclusion criteria, all subjects must:

  1. Age 50-80
  2. Be able to provide written informed consent or assent
  3. Be able to read, speak and understand English (The investigators do not have the resources necessary to properly study non-English speaking patients in this study, given that translation and validation of the assessment tools would be necessary)
  4. Be willing and able to participate in one PET/MRI scanning session

Additional Inclusion criteria for PD patients, subjects must:

1. Have an existing diagnosis of idiopathic PD, using consensus criteria
2. Stable medications for at least 30 days
3. Hoehn and Yahr stage I-IV
4. A study partner who can answer questions pertaining to daily functioning

Additional Inclusion criteria for MSA patients, subjects must:

1. Have an existing diagnosis of MSA, using consensus criteria
2. Stable medications for at least 30 days
3. MSAp or MSAc
4. A study partner who can answer questions pertaining to daily functioning

Additional Inclusion criteria for DLB patients, subjects must:

1. Have an existing diagnosis of probable DLB, using consensus criteria
2. Stable medications for at least 30 days
3. Clinical Dementia Rating Scale (CDR) \< 0.5
4. A study partner who can answer questions pertaining to daily functioning

Exclusion Criteria:

* General Exclusion Criteria (All Subjects)

  1. History of vascular risk factors (e.g. hypertension, hyperlipidemia), if not well-controlled
  2. Major psychiatric disease (e.g.schizophrenia)
  3. History of stroke
  4. Focal brain lesions on MRI scans
  5. History of other major illnesses including, but not limited to, major kidney or liver problems or significant neurological illness
  6. Recent surgery that is deemed major by our reviewing physician or nurse practitioner within the past 6 months
  7. History of head trauma (as defined as having any insults to the brain that may have resulted from an external mechanical force, such as rapid acceleration or deceleration, impact, blast waves, or penetration by a projectile)
  8. Impaired elimination (as defined as having problems with urination) unless being managed
  9. Past or present diagnosis of bipolar disorder or other Axis I diagnosis, (treated depression is allowed)
  10. Any present substance abuse including drug/alcohol abuse
  11. Inability to lie flat on camera bed for up to 90 min
  12. Pregnancy or breastfeeding
  13. Metallic foreign bodies that would be affected by the MRI magnet, or fear of enclosed spaces likely to make the subject unable to undergo an MRI scan
  14. Recent exposure to radiation (i.e., PET from other research) that, when combined with this study, would be above the allowable limits (50 milliSieverts)

General MR and PET safety exclusion criteria listed below

1. Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial hearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhere on the body, tattoos near the eye, steel implants, ferromagnetic objects such as jewelry or metal clips in clothing
2. Electrical implants such as cardiac pacemakers or perfusion pumps
3. Pre-existing medical conditions including a likelihood of developing seizures or claustrophobic reactions, and any greater than normal potential for cardiac arrest
4. Is unable to lie comfortably on a bed inside a PET camera with their head in the field of view for 60 to 90 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis)
5. Pregnancy: A negative serum pregnancy test is required on the day of the PET procedure in women of child bearing potential
6. Body weight of \> 300 lbs (weight limit of the MRI table)
7. Breast feeding mothers

Exclusion Criteria for Subjects Undergoing Blood Draws Through an Arterial Line During PET Scan

1. An abnormal result on the modified Allen's test on both hands
2. Raynaud syndrome
3. Bleeding disorder
4. Use of anticoagulants such as Coumadin, Plavix or Lovenox
5. An allergy to Lidocaine

Where this trial is running

Charlestown, Massachusetts

• Mgh — Charlestown, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Changning Wang, PhD

Conditions Parkinson's Disease; Multiple System Atrophy; Dementia With Lewy Bodies; Healthy Controls