--- title: Reduce hallucinations without worsening movement nct_id: NCT04373317 phase: PHASE4 status: RECRUITING sponsor: VA Office of Research and Development study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT04373317" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04373317" last_fetched: "2026-05-10T14:08:31.716Z" source: "Parkinson's Pathways (curated)" --- # Reduce hallucinations without worsening movement **Goal (in five words):** Reduce hallucinations without worsening movement **Official Title:** CSP #2015 - Multicenter, Randomized, Double-blind Comparator Study of Antipsychotics Pimavanserin and Quetiapine for Parkinson''s Disease Psychosis (C-SAPP) **Trial ID:** [NCT04373317](https://clinicaltrials.gov/study/NCT04373317) ## Key Facts - **Phase:** PHASE4 - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** VA Office of Research and Development - **Target Enrollment:** 358 participants - **Start Date:** 2022-10-24 - **Completion Date:** 2026-10-24 - **Conditions:** Parkinson's Disease Psychosis - **Interventions:** Pimavanserin, Quetiapine - **Intervention Types:** DRUG ## Summary For Families The goal is to see which antipsychotic better reduces hallucinations and delusions in people with Parkinson's, while minimizing worsening of movement or other side effects. It compares pimavanserin, which works as a serotonin 5-HT2A inverse agonist so it can reduce psychosis without blocking dopamine receptors and usually does not interfere with levodopa, to quetiapine, an atypical antipsychotic that blocks dopamine and serotonin receptors and can help psychosis but may cause sedation or worsen parkinsonism at higher doses. The study is looking for English-speaking veterans age 40 and older with Parkinson's and significant psychosis who are on stable PD medications and have a regular caregiver or "informed other" to attend visits, while excluding people with certain heart rhythm problems, recent high-dose antipsychotic use, dementia with Lewy bodies, or other serious medical issues. ## Eligibility - **Minimum age:** 40 Years - **Sex:** ALL ### Full Criteria ``` Inclusion Criteria: * Veteran * Age 40 years or older * 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 ``` ## Locations (24) - Southern Arizona VA Health Care System, Tucson, AZ, Tucson, Arizona, United States _(32.2217, -110.9265)_ - VA Loma Linda Healthcare System, Loma Linda, CA, Loma Linda, California, United States _(34.0483, -117.2612)_ - Dorothee Cole, MD — (CONTACT) — 909-825-7084 — Dorothee.Cole@va.gov - Sonia Read — (CONTACT) — 9098257084 — Sonia.Read@va.gov - VA Palo Alto Health Care System, Palo Alto, CA, Palo Alto, California, United States _(37.4419, -122.1430)_ - Shannon Kilgore, MD — (CONTACT) — 650-858-3999 — Shannon.Kilgore@va.gov - Cheyenne Murphy — (CONTACT) — 6504935000 — Cheyenne.Murphy@va.gov - San Francisco VA Medical Center, San Francisco, CA, San Francisco, California, United States _(37.7749, -122.4194)_ - VA Greater Los Angeles Healthcare System, West Los Angeles, CA, West Los Angeles, California, United States _(34.0462, -118.4307)_ - Rocky Mountain Regional VA Medical Center, Aurora, CO, Aurora, Colorado, United States _(39.7294, -104.8319)_ - Jeanne Feuerstein, MD — (CONTACT) — 720-723-6205 — Jeanne.Feuerstein@va.gov - North Florida/South Georgia Veterans Health System, Gainesville, FL, Gainesville, Florida, United States _(29.6516, -82.3248)_ - Edward Hines Jr. VA Hospital, Hines, IL, Hines, Illinois, United States _(41.8536, -87.8395)_ - Lexington VA Medical Center, Lexington, KY, Lexington, Kentucky, United States _(37.9887, -84.4777)_ - VA Ann Arbor Healthcare System, Ann Arbor, MI, Ann Arbor, Michigan, United States _(42.2776, -83.7409)_ - Minneapolis VA Health Care System, Minneapolis, MN, Minneapolis, Minnesota, United States _(44.9800, -93.2638)_ - James Ashe, MD — (CONTACT) — 612-725-2000 — James.Ashe@va.gov - Molly Carson — (CONTACT) — 6127252000 — Molly.Carson@va.gov - St. Louis VA Medical Center John Cochran Division, St. Louis, MO, St Louis, Missouri, United States _(38.6273, -90.1979)_ - New Mexico VA Health Care System, Albuquerque, NM, Albuquerque, New Mexico, United States _(35.0845, -106.6511)_ - Syracuse VA Medical Center, Syracuse, NY, Syracuse, New York, United States _(43.0481, -76.1474)_ - Asheville VA Medical Center, Asheville, NC, Asheville, North Carolina, United States _(35.6009, -82.5540)_ - Louis Stokes VA Medical Center, Cleveland, OH, Cleveland, Ohio, United States _(41.4995, -81.6954)_ - Peijun Chen — (CONTACT) — 216-791-3800 — Peijun.Chen@va.gov - Aasef Shaikh — (CONTACT) — 2167913800 — Aasef.Shaikh@va.gov - VA Portland Health Care System, Portland, OR, Portland, Oregon, United States _(45.5234, -122.6762)_ - Joel Mack, MD — (CONTACT) — 503-220-8262 — Joel.Mack@va.gov - Michael Tanaka — (CONTACT) — 5032208262 — Michael.Tanaka2@va.gov - Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA, Philadelphia, Pennsylvania, United States _(39.9524, -75.1636)_ - Daniel Weintraub, MD — (CONTACT) — (215) 823-5800 — daniel.weintraub@va.gov - Daniel Weintraub, MD — (STUDY_CHAIR) - Philadelphia MultiService Center, Philadelphia, PA, Philadelphia, Pennsylvania, United States _(39.9524, -75.1636)_ - James Morley, MD — (CONTACT) — 215-823-5934 — James.Morley@va.gov - Philip Danquah — (CONTACT) — Philip.Danquah@va.gov - Tennessee Valley Healthcare System Nashville Campus, Nashville, TN, Nashville, Tennessee, United States _(36.1659, -86.7844)_ - Michael E. DeBakey VA Medical Center, Houston, TX, Houston, Texas, United States _(29.7633, -95.3633)_ - Aliya Sarwar, MD — (CONTACT) — 713-794-7841 — Aliya.Sarwar@va.gov - Priscilla Bigner — (CONTACT) — 7137947939 — Priscilla.Bigner@va.gov - South Texas Health Care System, San Antonio, TX, San Antonio, Texas, United States _(29.4241, -98.4936)_ - Hunter Holmes McGuire VA Medical Center, Richmond, VA, Richmond, Virginia, United States _(37.5538, -77.4603)_ - VA Puget Sound Health Care System Seattle Division, Seattle, WA, Seattle, Washington, United States _(47.6062, -122.3321)_ ## Central Contacts - Daniel Weintraub, MD — (CONTACT) — (215) 823-5800 — daniel.weintraub@va.gov - John E Duda, MD — (CONTACT) — (215) 823-5934 — john.duda@va.gov --- *Canonical: https://parkinsonspathways.com/trial/NCT04373317* *HTML version: https://parkinsonspathways.com/trial/NCT04373317* *Source data: https://clinicaltrials.gov/study/NCT04373317*