Phase 2 Parkinson's Disease Trial, Recruiting NCT06679374 Sponsor: Vikas Kotagal Condition: Parkinson's Disease
Back to Parkinsons Disease

Phase 2 Parkinson's Disease Trial, Recruiting

NCT06679374
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 who have been diagnosed with Parkinson's disease using the Movement Disorders Society's official diagnostic criteria at the time of their first study visit
  • People whose brain scans (a specialised PET scan using a substance called FEOBV) show low levels of a specific type of nerve signalling in a region at the back of the brain
  • People who are either able to give their own informed consent to participate, as confirmed by a specific capacity assessment tool, or who have a legally authorised representative able to co-sign the consent form on their behalf
  • People who have mild memory or thinking difficulties that are consistent with a condition called Parkinson's disease Mild Cognitive Impairment (PD-MCI)

Who may not be able to join:

  • People who have a Parkinson's-like condition other than Parkinson's disease itself
  • People who are currently taking certain dopamine-blocking medications, specific anticholinergic drugs (such as trihexyphenidyl or benztropine), or certain cholinesterase inhibitor medications at the time of their screening visit (confirm with trial site for the full medication list)
  • People whose Parkinson's disease severity rates at 4.0 or higher on the Modified Hoehn and Yahr scale at the screening visit, indicating more advanced disease
  • People who are currently using, or have used in the past 6 months, any product containing nicotine or nicotine-like (nicotinic) agents, including cigarettes, cigars, pipes, chewing tobacco, e-cigarettes, nicotine patches, nicotine gum, or a medication called varenicline
  • People whose brain MRI shows evidence of a stroke affecting both outer and inner brain regions, or a growth in the back part of the brain, that would interfere with analysing the PET scan results
  • People for whom an MRI scan is not safe, such as those with a pacemaker, metal fragments near the eyes or spinal cord, or a cochlear implant
  • People with severe claustrophobia that would prevent them from undergoing an MRI or PET scan
  • People who have reached a limit on their participation in research that involves radiation exposure
  • People who are pregnant (a pregnancy test is required within 48 hours of the PET scan for women who could become pregnant) or who are breastfeeding at the time of the screening visit
  • People with stage 4 or 5 chronic kidney disease at the time of screening, meaning their kidneys are functioning at a significantly reduced level (confirm with trial site)
  • People experiencing a significant and ongoing mood disorder at the time of screening, defined as persistent symptoms of depression or anxiety lasting more than two weeks within the 30 days before signing the consent form, based on self-report
  • People showing active thoughts of suicide, as identified by specific questions on a standardised assessment tool called the Columbia Suicide Severity Rating Scale
  • People who have had a heart attack or unstable chest pain (unstable angina) in the 90 days before their enrolment visit
  • People with a current or past history of epilepsy, or who have had any seizures in the 12 months before their enrolment visit
  • People whose self-reported alcohol use scores 8 or higher on a standardised alcohol use assessment tool (the AUDIT) at the time of screening
  • People who are unable to swallow pills
  • People who have previously had an allergic reaction to a medication called varenicline
  • People who are currently taking part in another interventional clinical trial (observational studies are not affected by this criterion)

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
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

Principal Investigator: Vikas Kotagal, MD, University of Michigan

Phone: 734-615-4334

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 2
Sponsor
Vikas Kotagal
Registry
ClinicalTrials.gov
Start date
9 April 2025
Est. completion
1 January 2029

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in normal pace-dual task cost (npDTC) from baseline to 12 months.

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