Parkinson DiseaseNCT05240339
Characterization and Progression of Minor Phenomena in Parkinson's Disease (PD)
An observational study of Parkinson Disease and Parkinson Disease Psychosis, run by University of Rochester at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Parkinson Disease, Parkinson Disease Psychosis, Hallucinations
- What is being tested?
- Observation of minor phenomena
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Apr 2019to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Characterization and Progression of Minor Phenomena in Parkinson's Disease
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:
- To determine the cumulative probability of developing hallucinations or delusions over time in individuals with PD minor phenomena followed for 36 months.
- Being tested
- Observation of minor phenomena
- Medical subject headings
- Parkinson Disease, Hallucinations, Delusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observation of minor phenomenaOther
observation twice a year over 3 years
| Study group | Role | What they receive |
|---|---|---|
| PD participants with minor phenomena | Not described Receives: Other: Observation of minor phenomena |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2022
- Study start25 Apr 2019
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- ACADIA Pharmaceuticals Inc.
- Responsible party
- Principal investigator, Ruth Schneider, MD, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05240339
- Sponsor's protocol ID
- STUDY00003440
- Status last verified
- Mar 2024
- First submitted
- 4 Feb 2022
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization and Progression of Minor Phenomena in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT05240339
- Acronym / sponsor ID
- STUDY00003440
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- ACADIA Pharmaceuticals Inc.
- Study start
- 25 Apr 2019 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 15 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the cumulative probability of developing hallucinations or delusions over time in individuals with PD minor phenomena followed for 36 months.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PD participants with minor phenomena | – | Other: Observation of minor phenomena |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observation of minor phenomenaobservation twice a year over 3 years | Other | PD participants with minor phenomena |
Primary outcome
Cumulative probability of developing hallucinations or delusions over time
Time frame: 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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Individual participant dataSharing planned: No
Related trials for Parkinson Disease
Not yet recruitingPhase 1/2
STAR0602 With Nivolumab in Non Small Cell Lung Cancer and in Metastatic Castrate-Resistant Prostate Cancer, and STAR0602 Alone in Thymic Carcinoma
NSCLC, Non-Small Cell Lung Cancer
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
RecruitingPhase 3
A Clinical Study of Sacituzumab Tirumotecan (MK-2870) in Combination With Pembrolizumab (MK-3475) as First-line Maintenance Treatment of Cervical Cancer (MK-2870-036/TroFuse-036/GOG-3123/ENGOT-cx22)
Cervical Cancer
Active, not recruitingPhase 1/2
Clinical Safety and Efficacy of Umbilical Cord Mesenchymal Stromal Cells-derived Exosomes in Patients With Parkinson's Disease
Parkinson Disease (PD)
Active, not recruitingObservational study
Adaptive DBS to Offset STN Dysregulation During Exercise in PD
Parkinson Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Parkinson Disease Psychosis, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative probability of developing hallucinations or delusions over time (time frame: baseline to 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.