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| Name | Class |
|---|---|
| ACADIA Pharmaceuticals Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PD participants with minor phenomena |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Observation of minor phenomena | Other | observation twice a year over 3 years |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D006212 | Hallucinations |
| D003702 | Delusions |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |