Characterization and Progression of Minor Phenomena in Parkinson's Disease (PD)

• Sponsor: University of Rochester (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05240339
• Collaborator: ACADIA Pharmaceuticals Inc. (Industry)
• Enrollment: 38
• Location: 1
• Anticipated Duration (Months): 44.3
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

Parkinson's disease psychosis encompasses a range of symptoms, including minor phenomena, frank hallucinations, and delusions. Minor phenomena include passage hallucinations (fleeting sense of a person, animal or object passing in the periphery), presence hallucinations (feeling of nearby presence), and illusions (misrepresentation of external stimuli). Some forms of PD psychosis may be progressive. The primary objective of this study is to:

1. To determine the cumulative probability of developing hallucinations or delusions over time in individuals with PD minor phenomena followed for 36 months.

Condition or Disease	Intervention/Treatment	Phase
Parkinson Disease; Parkinson Disease Psychosis; Hallucinations; Delusion	Other: Observation of minor phenomena

Study Design

• Study Type: Observational
• Actual Enrollment: 38 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Characterization and Progression of Minor Phenomena in Parkinson's Disease
• Actual Study Start Date: Apr 25, 2019
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
PD participants with minor phenomena	Other: Observation of minor phenomena; observation twice a year over 3 years

Outcome Measures

Primary Outcome Measures

1. Cumulative probability of developing hallucinations or delusions over time [baseline to 36 months]

   Kaplan-Meier curves will be used to describe the cumulative probability of hallucinations and/or delusions over time. Participants will be determined to have met the primary endpoint if they have hallucinations and/or delusions on the basis of interview or initiate treatment with an antipsychotic medication.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 30 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Parkinson's disease (as determined by Movement Disorders Society diagnostic criteria for clinically probable Parkinson's disease)

• Parkinson's disease minor phenomena

• ≥30 years of age

• Proficient in English

• Willing and able to provide informed consent

Exclusion Criteria:

• Any current or prior history of formed hallucinations or delusions

• Current or prior treatment with an antipsychotic medication (regardless of indication)

• Diagnosis of mania with psychotic features, bipolar or related disorder, depression with psychotic features, or a psychotic disorder

• Unable or unwilling to complete study activities

• Any medical or psychiatric comorbidity that, in the opinion of the investigator, would compromise study participation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester
• ACADIA Pharmaceuticals Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ruth Schneider, MD, Associate Professor, University of Rochester
• ClinicalTrials.gov Identifier: NCT05240339
• Other Study ID Numbers: STUDY00003440
• First Posted: Feb 15, 2022
• Last Update Posted: Feb 15, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Parkinson Disease; Hallucinations; Delusions

Study Results

No Results Posted as of Feb 15, 2022