Parkinson's Disease Trial, Recruiting NCT07567794 Sponsor: Duke University Condition: Parkinson's Disease
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Parkinson's Disease Trial, Recruiting

NCT07567794
Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

People with Parkinson's disease (PD):

  • People aged 21 to 80 years old
  • People who have been clinically diagnosed with Parkinson's disease according to the Movement Disorder Society (MDS) criteria
  • People with adequate vision, hearing, thinking ability, and physical ability to participate
  • People who are willing and able to attend scheduled visits, complete lab tests, and follow study procedures — and who the enrolling doctor believes are likely to remain committed and able to travel to the site for up to three years

People joining as healthy controls (comparison group):

  • People aged 21 to 80 years old
  • People with no known or diagnosed neurodegenerative disease
  • People who are willing and able to attend scheduled visits and complete lab tests and other study procedures
  • People who live in the same household as someone with Parkinson's disease

People joining as the "prodromal" group (early or at-risk stage):

  • People aged 21 to 80 years old
  • People who show early characteristics associated with Parkinson's disease, as defined by MDS research criteria — specifically, either a sleep disorder called REM sleep behavior disorder (confirmed by a sleep study or identified through a questionnaire), combined with a reduced sense of smell as measured by a standardised smell test (confirm with trial site)

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have been diagnosed with a secondary or atypical form of parkinsonism (a different type of movement disorder, not standard Parkinson's disease)
  • People whose blood test results fall outside acceptable ranges — including low haemoglobin (below 10), low platelet count (below 70,000), liver enzyme levels more than 2.5 times the upper limit of normal, moderate or severe kidney or liver disease based on specific test values, or abnormal blood clotting results (confirm with trial site for exact values)
  • People currently taking blood-thinning medications that the trial doctor considers to carry too high a bleeding risk for a bowel examination procedure called a sigmoidoscopy
  • People with significant thinking or memory difficulties, defined as scoring below 22 on a standard cognitive assessment called the MoCA
  • People whose clinical or lab results suggest another primary brain or nervous system disease other than Parkinson's disease — including conditions such as Huntington's disease, Alzheimer's disease, dementia with Lewy bodies, progressive supranuclear palsy, multisystem atrophy, frontotemporal lobar disease, motor neurone disease, Creutzfeldt-Jakob disease, Down syndrome, corticobasal degeneration, stroke, seizure disorder, or certain infections or metabolic conditions affecting the brain such as untreated thyroid problems or untreated vitamin B12 deficiency
  • People who have had active suicidal thoughts in the six months before screening, who answer yes to certain questions on a standardised suicide assessment scale, who have attempted suicide in the past two years, or who the trial doctor considers to be at serious risk of suicide
  • People who currently have cancer or have had a cancerous tumour within the past five years (note: people with stable untreated prostate cancer, or who have had skin cancers that were treated or removed, are not excluded)
  • People with any other medical condition or systemic illness that the trial doctor believes could put them at risk, affect the study results, or prevent full participation
  • People with a body mass index (BMI) above 35, or who weigh less than 50 kg
  • People who are currently pregnant, breastfeeding, or lactating
  • People with a history of alcohol or substance abuse or dependence within the past two years
  • People who have had a confirmed COVID-19 infection within six weeks before screening
  • People who still have unresolved symptoms from a COVID-19 infection, or ongoing thinking or other difficulties linked to long COVID, that the trial doctor believes could affect safety or interfere with cognitive assessments
  • People who are currently participating in another clinical trial involving an investigational drug and have taken at least one dose within four weeks before screening (or within five half-lives of that drug, whichever is longer) — unless they have been unblinded and confirmed to have been on placebo
  • People with a history of bowel surgery (note: people who have had an appendix removal, haemorrhoid surgery, or gallbladder removal are not excluded)
  • People who regularly use medications that affect the gut lining, such as anti-inflammatory painkillers (NSAIDs) taken more than three times per week
  • People with a history of Crohn's disease, ulcerative colitis, other types of colitis (including microscopic, lymphocytic, or collagenous colitis), active or uncontrolled inflammatory bowel disease symptoms such as diarrhoea, bleeding, or severe stomach pain, treatment for inflammatory bowel disease in the past six months with steroids, biologics, or strong immune-suppressing drugs, bowel surgery due to inflammatory bowel disease, or other long-term gut conditions that cause inflammation such as coeliac 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 15 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.

If you need support right now

This page includes language about suicide and self-harm, because that is how the trial's eligibility criteria are written. If reading it has been hard, you do not have to keep going. The services below are free, confidential, and answered by people trained for exactly this.

If you or someone else is in immediate danger, call 000.

  • Lifeline — 24/7 crisis support: 13 11 14
  • Suicide Call Back Service — 24/7 counselling: 1300 659 467
  • 13YARN — 24/7, for Aboriginal and Torres Strait Islander people: 13 92 76
  • Beyond Blue — 24/7 mental health support: 1300 22 4636
  • Emergency: 000

Outside Australia? The numbers above are Australian and will not work from overseas. Find a Helpline is a free directory of crisis lines in over 130 countries, run by ThroughLine with the International Association for Suicide Prevention. If you are in immediate danger, call your local emergency number.

Voxsanity is not a crisis service, and nothing on this page is medical advice. More Australian services are listed on our support lines page.

GP referral letter

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Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
Registry
ClinicalTrials.gov
Start date
4 June 2026
Est. completion
31 December 2028

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

GI influences on PD; Co-associations components of the GBA

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: 15 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