Phase 4 Parkinson's Disease Trial, Recruiting NCT05357612 Sponsor: Vanderbilt University Medical Center Condition: Parkinson's Disease
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Phase 4 Parkinson's Disease Trial, Recruiting

NCT05357612
Recruiting Phase 4

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:

  • People who have been clinically diagnosed with Parkinson's disease, diffuse Lewy body disease, multiple systems atrophy, Huntington's Disease, Frontotemporal Dementia, or a related condition (patient group)
  • People who are healthy and are matched by age and gender to someone in the patient group (healthy comparison group)
  • People in the patient group who have experienced hallucinations or delusions that started after their neurological diagnosis, happen at least once a week for four weeks, and are severe enough that a doctor considers treatment necessary
  • People who have a study partner (such as a family member or carer) who is able to attend study visits with them

Who may not be able to join:

  • People who have had a stroke in the past, or who have another serious neurological or medical condition that is not well controlled
  • People who are unable to have an MRI scan, or for whom an MRI scan would be medically unsafe
  • People who have taken serotonin-related medications within the last six weeks
  • People who are not able to give their own independent consent to take part
  • People who are pregnant or breastfeeding
  • People whose hallucinations or delusions are caused by a metabolic condition, toxic substance, or a primary psychiatric illness (rather than their neurological diagnosis)
  • People who a doctor considers unlikely to be able to complete the thinking and memory tests involved in the study
  • People with Parkinson's disease who are currently taking, or have previously taken, the medication pimavanserin
  • People who have taken antipsychotic medications within the last two weeks

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 27 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Ciaran Considine, PhD, Vanderbilt University Medical Center

Phone: 6154210569

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

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
23 January 2023
Est. completion
1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in 5HT2A receptor density measured using the PET radioligand MH.MZ; Change in 5HT2A receptor binding occupancy measured using the PET radioligand MH.MZ

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: 27 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