Phase 2 Parkinson's Disease Trial, Recruiting NCT06402955 Sponsor: Yale University Condition: Parkinson's Disease
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Phase 2 Parkinson's Disease Trial, Recruiting

NCT06402955
Recruiting Phase 2

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 between 40 and 80 years of age
  • Women who could become pregnant must have a negative pregnancy test at the time of screening and scanning
  • People with a clinical diagnosis of Parkinson's disease who are able to give consent and tolerate PET scan procedures
  • People with Parkinson's disease and depression must have at least moderate depression symptoms, shown by a score of 15 or higher on a standard depression rating scale called the MADRS
  • People with Parkinson's disease and depression who are receiving ketamine must abstain from recreational drugs (other than alcohol, cannabis, nicotine, and caffeine) for the duration of the study

Who may not be able to join:

  • People with dementia, indicated by a score below 21 on a standard memory and thinking test called the MoCA
  • People with a significant psychiatric condition other than major depressive disorder (MDD)
  • People with unstable or serious medical conditions (such as heart or kidney problems) or neurological conditions (such as stroke history, seizures, or traumatic brain injury) other than Parkinson's disease, where these conditions could increase risk or affect study results, as determined by the study doctors
  • People who have had prior radiation exposure from research studies that would exceed safe annual limits set by the FDA if they were to participate in this study
  • People taking certain medications that affect a specific brain protein called SV2A (for example, a seizure medication called levetiracetam)
  • People with Parkinson's disease and depression who are receiving ketamine and have uncontrolled high blood pressure (defined as an average reading of 140/90 mmHg or higher)
  • People who cannot have an MRI scan for any reason
  • People who require a specific type of blood sampling during the PET scan and have an iodine allergy, a bleeding disorder, or are taking blood-thinning medications
  • People who are unable to provide written consent in English following the guidelines of the Yale Human Investigation Committee
  • People with a substance use disorder as defined by standard psychiatric diagnostic criteria (DSM-5)

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 21 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 2036854066

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
Phase 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 September 2024
Est. completion
1 January 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Montgomery-Åsberg Depression Rating Scale (MADRS)

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: 21 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