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

Characterization and Progression of Minor Phenomena in Parkinson's Disease

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05240339
Enrollment
38
Registered
2022-02-15
Start date
2019-04-25
Completion date
2023-12-31
Last updated
2024-03-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delusion, Hallucinations, Parkinson Disease, Parkinson Disease Psychosis

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.

Interventions

OTHERObservation of minor phenomena

observation twice a year over 3 years

Sponsors

ACADIA Pharmaceuticals Inc.
CollaboratorINDUSTRY
University of Rochester
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
30 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Cumulative probability of developing hallucinations or delusions over timebaseline to 36 monthsKaplan-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026