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

NCT05240339 | Completed

• 1 other identifier: STUDY00003440
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Parkinson Disease Psychosis; Hallucinations; Delusion

Outcome Measures

Primary Outcomes (1)

• Cumulative probability of developing hallucinations or delusions over time

  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.

  baseline to 36 months

Study Arms (1)

PD participants with minor phenomena

Other: Observation of minor phenomena

Interventions

Observation of minor phenomena OTHER

observation twice a year over 3 years

PD participants with minor phenomena

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants must meet criteria for clinically probable PD according to the MDS clinical diagnostic criteria for PD. Notably, in these new criteria, PD and dementia with Lewy bodies are recognized as most likely existing on a continuous spectrum and dementia is not an exclusion criterion for PD.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• ACADIA Pharmaceuticals Inc.: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Hallucinations; Delusions

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 4, 2022
• First Posted: February 15, 2022
• Study Start: April 25, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 8, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)