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

NCT ID: NCT05240339

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

38 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-25

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Parkinson Disease Parkinson Disease Psychosis Hallucinations Delusion

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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PD participants with minor phenomena

Observation of minor phenomena

Intervention Type OTHER

observation twice a year over 3 years

Interventions

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Observation of minor phenomena

observation twice a year over 3 years

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ACADIA Pharmaceuticals Inc.

INDUSTRY

Sponsor Role collaborator

University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Ruth Schneider, MD

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Rochester Medical Center

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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STUDY00003440

Identifier Type: -

Identifier Source: org_study_id

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