Comparing Pimavanserin and Quetiapine for Parkinson's Psychosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to compare the effectiveness of Pimavanserin and Quetiapine in treating psychosis symptoms in veterans with Parkinson's disease. It focuses on patients who experience hallucinations or delusions, which can significantly impact their quality of life. Participants must be stable on their Parkinson's medications and have a caregiver who can provide support throughout the study. The trial is conducted across multiple VA health care systems in California and Arizona.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Veteran
* Diagnosis of Parkinson's Disease consistent with UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria
* Psychosis \[with Neuropsychiatric Inventory (NPI) hallucinations (B) or delusions (A) score 4 or greater\]
* Stable dose of PD medications for at least 2 weeks
* If on an acetylcholinesterase inhibitor (AChEI) initially prescribed at least 3 months prior and stable dose (no dose or medication change) for past month
* Informed other must provide informed consent and agree to attend all study visits. The informed other must be at least 18 years of age and have regular contact with the patient (on average at least 4 days per week and at least 2 hours per day, or at least 3 days per week and at least 4 hours per day, that is with patient) via in-person, video, or telephone
* English-speaking

INFORMED OTHER

* Age 18 years or older
* Must have regular contact with the patient (on average at least 4 days per week, and at least 2 hours per day, or at least 3 days per week and at least 4 hours pr day, that is with patient) via in-person, video, or telephone
* Agree to attend all study visits
* Be able to provide informed consent
* English-speaking

Exclusion Criteria:

* Psychosis symptoms severe enough to preclude enrollment in a clinical trial and require prompt clinical care instead
* Treatment with quetiapine \>50 mg/day or pimavanserin in the past 3 months, or quetiapine 50 mg/day or another antipsychotic in the past week prior to study randomization
* Deep brain stimulation (DBS) surgery within 3 months or has had stimulator adjustments in the previous 2 weeks
* History of a psychotic disorder prior to PD, including bipolar disorder, schizophrenia, schizoaffective disorder, and major depressive disorder with psychotic features, if it is thought to be the cause of the current psychosis symptoms
* Suspected atypical parkinsonian disorder or dementia with Lewy bodies (DLB)
* Psychosis secondary to other toxic or metabolic disorder
* History of long QT syndrome
* Documented chart evidence indicating persistent hypoglycemia, hypokalemia, hypomagnesemia that would put patient at increased risk for QTc prolongation.
* History of ventricular arrhythmias, except when treated with an implantable cardioverter defibrillator (ICD) or pacemaker, or untreated or unstable atrial fibrillation/flutter
* Currently taking medications that are moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors
* Concomitant use of drugs that prolong the QTc interval with a known risk of Torsades de Pointes
* Comorbid medical condition determined too severe by Site Investigator to allow participation in clinical trial
* Failure to tolerate quetiapine or pimavanserin previously
* Severe cognitive impairment (MoCA score \<5)
* Nursing home placement at screening or planned placement during the study, unless approved by study Co-Chairs. Approval will depend upon nursing facility agreement to receive, return, and administer medications or allow participant to self-administer study medications; appropriate IO availability; and transportation availability for study visits.
* Currently enrolled in another therapeutic or interventional study
* Pregnant, or a female of child-bearing potential who is unwilling to use a reliable form of contraception

Where it's running

• VA Loma Linda Healthcare System, Loma Linda, CA
  Loma Linda, California, United States Recruiting
• VA Palo Alto Health Care System, Palo Alto, CA
  Palo Alto, California, United States Recruiting
• Rocky Mountain Regional VA Medical Center, Aurora, CO
  Aurora, Colorado, United States Recruiting
• Minneapolis VA Health Care System, Minneapolis, MN
  Minneapolis, Minnesota, United States Recruiting
• Louis Stokes VA Medical Center, Cleveland, OH
  Cleveland, Ohio, United States Recruiting
• VA Portland Health Care System, Portland, OR
  Portland, Oregon, United States Recruiting

Study contacts

• Study coordinator: Daniel Weintraub, MD
• Email: daniel.weintraub@va.gov
• Phone: (215) 823-5800

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Using a PET tracer to study serotonin receptors in neurodegenerative diseases

  This study is testing how a new imaging method can help us understand serotonin receptors in people with neurodegenerative diseases like Parkinson's and see if a medication can improve their psychosis symptoms.

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• ML-007C-MA for hallucinations and delusions in Alzheimer's disease

  This will test whether ML-007C-MA reduces hallucinations and delusions in people aged 55–90 with Alzheimer's-related psychosis.

  Recruiting at 61 sites Phase 2 MapLight Therapeutics · Phoenix, Arizona and 61 other locations · NCT06887192

• KarXT for psychosis in people with Alzheimer's disease

  This Phase 3 test will see if KarXT reduces hallucinations and delusions in people aged 55–90 who have Alzheimer's-related psychosis.

  Recruiting at 7 sites Phase 3 Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Chandler, Arizona and 156 other locations · NCT06126224

• Long-term safety assessment of KarXT for Alzheimer's-related psychosis

  This study is testing the long-term safety of a treatment called KarXT for people with Alzheimer's-related psychosis who have already participated in earlier trials.

  Recruiting at 132 sites Phase 3 Karuna Therapeutics, Inc., a Bristol Myers Squibb company · Homewood, Alabama and 431 other locations · NCT05980949

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.