Last updated: March 11, 2024
Sponsor: Massachusetts General Hospital
Overall Status: Active - Recruiting
Phase
1
Condition
Dyskinesias
Multiple System Atrophy
Parkinson's Disease
Treatment
C11-SY08
Clinical Study ID
NCT06098612
2023P002302
Ages 50-80 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- General Inclusion criteria, all subjects must:
- Age 50-80
- Be able to provide written informed consent or assent
- Be able to read, speak and understand English (The investigators do not have theresources necessary to properly study non-English speaking patients in thisstudy, given that translation and validation of the assessment tools would benecessary)
- Be willing and able to participate in one PET/MRI scanning session Additional Inclusion criteria for PD patients, subjects must:
- Have an existing diagnosis of idiopathic PD, using consensus criteria
- Stable medications for at least 30 days
- Hoehn and Yahr stage I-IV
- A study partner who can answer questions pertaining to daily functioning Additional Inclusion criteria for MSA patients, subjects must:
- Have an existing diagnosis of MSA, using consensus criteria
- Stable medications for at least 30 days
- MSAp or MSAc
- A study partner who can answer questions pertaining to daily functioning Additional Inclusion criteria for DLB patients, subjects must:
- Have an existing diagnosis of probable DLB, using consensus criteria
- Stable medications for at least 30 days
- Clinical Dementia Rating Scale (CDR) < 0.5
- A study partner who can answer questions pertaining to daily functioning
Exclusion
Exclusion Criteria:
- General Exclusion Criteria (All Subjects)
- History of vascular risk factors (e.g. hypertension, hyperlipidemia), if notwell-controlled
- Major psychiatric disease (e.g.schizophrenia)
- History of stroke
- Focal brain lesions on MRI scans
- History of other major illnesses including, but not limited to, major kidney orliver problems or significant neurological illness
- Recent surgery that is deemed major by our reviewing physician or nursepractitioner within the past 6 months
- History of head trauma (as defined as having any insults to the brain that mayhave resulted from an external mechanical force, such as rapid acceleration ordeceleration, impact, blast waves, or penetration by a projectile)
- Impaired elimination (as defined as having problems with urination) unless beingmanaged
- Past or present diagnosis of bipolar disorder or other Axis I diagnosis, (treateddepression is allowed)
- Any present substance abuse including drug/alcohol abuse
- Inability to lie flat on camera bed for up to 90 min
- Pregnancy or breastfeeding
- Metallic foreign bodies that would be affected by the MRI magnet, or fear ofenclosed spaces likely to make the subject unable to undergo an MRI scan
- Recent exposure to radiation (i.e., PET from other research) that, when combinedwith this study, would be above the allowable limits (50 milliSieverts) General MR and PET safety exclusion criteria listed below
- Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificialhearts, valves with steel parts, metal fragments, shrapnel, metallic tattoos anywhereon the body, tattoos near the eye, steel implants, ferromagnetic objects such asjewelry or metal clips in clothing
- Electrical implants such as cardiac pacemakers or perfusion pumps
- Pre-existing medical conditions including a likelihood of developing seizures orclaustrophobic reactions, and any greater than normal potential for cardiac arrest
- Is unable to lie comfortably on a bed inside a PET camera with their head in the fieldof view for 60 to 90 minutes as assessed by physical examination and medical history (e.g. back pain, arthritis)
- Pregnancy: A negative serum pregnancy test is required on the day of the PET procedurein women of child bearing potential
- Body weight of > 300 lbs (weight limit of the MRI table)
- Breast feeding mothers Exclusion Criteria for Subjects Undergoing Blood Draws Through an Arterial Line During PETScan
- An abnormal result on the modified Allen's test on both hands
- Raynaud syndrome
- Bleeding disorder
- Use of anticoagulants such as Coumadin, Plavix or Lovenox
- An allergy to Lidocaine
Study Design
Total Participants: 40
Treatment Group(s): 1
Primary Treatment: C11-SY08
Phase: 1
Study Start date:
May 01, 2024
Estimated Completion Date:
November 30, 2025
Connect with a study center
MGH
Charlestown, Massachusetts 02129-2020
United StatesActive - Recruiting
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