Parkinson's Disease Trial, Recruiting NCT05565443 Sponsor: InSightec Condition: Parkinson's Disease
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Parkinson's Disease Trial, Recruiting

NCT05565443
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Men or women between 35 and 80 years old (inclusive)
  • People who are able and willing to give their formal agreement to take part
  • People who have been diagnosed with Parkinson's disease (PD) according to a specific set of internationally recognised diagnostic guidelines (the MDS Clinical Diagnostic Criteria)
  • People who were first diagnosed with Parkinson's disease at least 2 years ago
  • People whose Parkinson's disease falls within a mild-to-moderate range of severity (Hoehn and Yahr Stage 1–3) while on their Parkinson's medication
  • People whose brain scan (called a DAT SPECT scan) has confirmed a reduction in dopamine activity, consistent with Parkinson's disease
  • People who have been on a stable Parkinson's medication routine for at least 90 days before the study begins
  • People whose overall health has been assessed and rated within an acceptable range for medical procedures (ASA score 1–3, as determined by a medical professional)
  • People who carry at least one specific gene variant called a GBA mutation (if joining the GBA Parkinson's arm of the trial), or people who carry two normal copies of the GBA gene with no mutations (if joining the idiopathic Parkinson's arm)

Who may not be able to join:

  • Women who are pregnant (confirmed by a positive pregnancy test, for those who have not yet gone through menopause)
  • People who have a known allergy or medical reason they cannot receive a specific ultrasound contrast agent called DEFINITY or perflutren (for example, a known hole or abnormal connection in the heart)
  • People who cannot have an MRI scan or receive a contrast dye called gadolinium-DTPA (for example, due to an incompatible implanted device or a known allergy)
  • People with insulin-dependent diabetes that is not well managed, or that a doctor considers would make participation unsafe
  • People with severely reduced kidney function (eGFR below 30 mL/min/1.73m²) or who are currently on dialysis
  • People who are currently taking part in another clinical treatment trial
  • People currently receiving a medication called bevacizumab (also known as Avastin)
  • People who have signs of an active infection in the brain or elsewhere in the body
  • People who have a condition affecting the blood vessels of the brain or body (cerebral or systemic vasculopathy)
  • People who have had a stroke in the past 12 months, or a mini-stroke (TIA) in the past month
  • People who have had a previous allergic reaction to a type of enzyme therapy called GCase enzyme therapy
  • People whose symptoms suggest a Parkinson's-like condition other than Parkinson's disease itself (confirm with trial site)
  • People who have previously had brain surgery for Parkinson's disease

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +1-817-948-5219

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
InSightec
Registry
ClinicalTrials.gov
Start date
30 November 2022
Est. completion
31 December 2027

Where this trial is recruiting

🇨🇦 Canada

Primary endpoints

Adverse Events

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov