Phase 4 Parkinson's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• The person with Parkinson's disease must be a veteran aged 40 or older.
• The person must have a confirmed diagnosis of Parkinson's disease based on a specific set of recognised diagnostic guidelines (UK Parkinson's Disease Society Brain Bank Clinical Diagnostic Criteria).
• The person must be experiencing psychosis symptoms — such as hallucinations or delusions — that score at a certain level of severity on a standard assessment tool called the Neuropsychiatric Inventory.
• The person must have been on a stable dose of their Parkinson's disease medications for at least 2 weeks before joining.
• If the person is taking a type of memory-related medication called an acetylcholinesterase inhibitor, it must have been first prescribed at least 3 months ago, with no dose changes in the past month.
• The person must speak English.
• A nominated support person (called an "informed other") must agree to take part, attend all study visits, and provide their consent to participate.

The support person ("informed other") must also meet these criteria:

• Be aged 18 or older.
• Have regular, frequent contact with the patient — either at least 4 days per week for at least 2 hours per day, or at least 3 days per week for at least 4 hours per day — whether in person, by video, or by phone.
• Agree to attend all study visits.
• Be able to give their own informed consent.
• Speak English.

Who may not be able to join:

• People whose psychosis symptoms are so severe that they need immediate clinical treatment rather than participation in a trial.
• People who have taken the antipsychotic medication quetiapine at doses above 50 mg per day, or pimavanserin, in the past 3 months — or who have taken quetiapine at 50 mg per day or any other antipsychotic medication in the past week before the study begins.
• People who have had deep brain stimulation (DBS) surgery within the past 3 months, or who have had their DBS device adjusted in the past 2 weeks.
• People who had a psychotic disorder (such as schizophrenia, bipolar disorder, schizoaffective disorder, or major depression with psychotic features) before their Parkinson's diagnosis, if that earlier condition is thought to be causing current psychosis symptoms.
• People suspected of having an atypical form of Parkinsonism or a condition called dementia with Lewy bodies.
• People whose psychosis is caused by a toxic substance or a metabolic (body chemistry) problem.
• People with a history of a heart condition called long QT syndrome.
• People with documented, ongoing low blood sugar, low potassium, or low magnesium levels, as these could increase the risk of a specific heart rhythm problem called QTc prolongation.
• People with a history of certain serious heart rhythm problems (ventricular arrhythmias), unless they have a device such as a pacemaker or implantable cardioverter defibrillator (ICD) already treating it — or people with untreated or unstable irregular heartbeat (atrial fibrillation or flutter).
• People currently taking certain medications that significantly affect how the body processes other drugs (moderate or strong CYP3A4 inducers or strong CYP3A4 inhibitors — confirm with trial site for specific medications).
• People taking other medications known to affect heart rhythm in a way that raises the risk of a serious condition called Torsades de Pointes.
• People with another serious medical condition that the site investigator considers too severe to safely allow trial participation.
• People who have previously been unable to tolerate quetiapine or pimavanserin.
• People with very severe cognitive impairment, specifically a score below 5 on a standard cognitive test called the MoCA.
• People who are living in or planning to move to a nursing home during the study, unless the trial's co-chairs approve the arrangement based on specific conditions being met (confirm with trial site).
• People currently enrolled in another treatment or intervention study.
• People who are pregnant, or women of childbearing potential who are unwilling to use a reliable form of contraception.

Important: Always verify eligibility with the trial site directly before applying.