Parkinson DiseaseNCT06156917
Evaluation of Autonomic, Imaging and Genetic Markers for Parkinson-related Dementia : Longitudinal Assessment of a PD Cohort.
An observational study of Parkinson Disease, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Neuropathologically, Parkinson disease (PD) is characterized by the accumulation of intra-neuronal protein aggregates (Lewy bodies and Lewy neurites). It is believed that altered rt-synuclein protein handling plays a key role in the etiopathogenesis of PD, because it is the principal component of Lewy pathology. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- diagnostic accuracy
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2018to 1 Sep 2020
- 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 40 to 70 years
- All sexes
- Adult, Older adult
Study population: This project provides the opportunity to collect and characterize a large cohort of PD patients to be studied prospectively. We will evaluate whether dlfferences In the measured variables exist between patients who will develop dementia (primary endpoint) within the observatlon time frame and those who will remain free from cognitive impairment at follow-up. We will compare PD patients who reach this endpoint before 10 years from disease onset to those who by that tlme remain cognitively preserved.
Who may be able to join
- Diagnosis of "clinically established PD" based on the MDS clinical diagnostic criteria.
- Age at disease onset will be between 40 and 70.
Who cannot join
- severe autonomic dysfunction (as defined in red flag 5a and 5b) will be an exclusion criterion Previous deep brain stimulation is an exclusion criterion.
Trial locations and contacts
1 site in 1 country.
About this study
Neuropathologically, Parkinson disease (PD) is characterized by the accumulation of intra-neuronal protein aggregates (Lewy bodies and Lewy neurites). It is believed that altered rt-synuclein protein handling plays a key role in the etiopathogenesis of PD, because it is the principal component of Lewy pathology. Recent evidence now suggests the possibility that a-synuclein is a prion-like protein and that PD is a prion-like disease. Some studies have suggested that environmental toxins promote the release of a-synuclein by enter- ic neurons and that released enteric a-synuclein is taken up by presynaptic sympathetic neurites and retro- gradely transported to the soma, where it accumulates, thus mediating the progression of PD pathology. These data indicate the precocity of autonomic nervous system involvement with reference to further spread of a-synuclein pathology. We have evidence from a previous study that the vagal preganglionic pro- jections to the gut express a-synuclein, thus providing a candidate a-synuclein-expressing pathway for the retrograde transport of pathogens to the central nervous system. Cardiovascular autonomic dysfunction explores the reactivity of sympathetic and parasympathetic pathways to a predefined set of tests, allowing to quantify the degree of dysfunction in each of the two components of the autonomic nervous system.
Mutations in the GBA gene influence the risk for dementia in PD 21; this effect of GBA is not synergistic with that of increasing age. Heterozygous GBA mutations are considered an important risk factor for PD and dementia, possibly causing a wider protein accumulation in the brain. In vitro models of alpha-synuclein aggregation have provided evidence for co-localization with mutant GBA . It has been proposed that a gain of function mechanism operates in patients with PD carrying GBA gene mutations, whereby mutant G8A promotes alpha-synuclein aggregation, accelerating Lewy body formation and neuronal loss.
Each of the selected variables provides a unique window to ascertain the association between PD patho- physiology and the risk of related dementia. Our hypothesis is that PD patients who develop incident dementia will have a number of statistically different abnormalities that will be evidenced as individual predictors and will also be assembled into a predictive algorithm. This project addresses a key issue in Parkinson disease, a progressive neurodegenerative condition, related to the assessment of variables associated to the development of dementia. The project is focused on dementia as a significant and important clinical milestone that constitutes the main cause of non-reversible functional impairment in PD patients.
- Conditions
- Parkinson Disease
- Being tested
- diagnostic accuracy
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diagnostic accuracyDiagnostic test
Aims of the present project are: to investigate the relationship between incident PD dementia and multimodal parameters as cardiovascular autonomic dysfunction, altered cerebral glucose metabolism, and genetic biomarkers; development of an algorithm predictive for PD-related dementia, combining the rele- vant multidimensional parameters under study; longitudinal follow-up of clinical and cognitive status in PD patients with and without dementia along four years.
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation of dysautonomia with incident dementia associated to PD
.At the end of the study, the patients will be divided in two groups: demented and non-demented. Dysauto- nomia measures wili be based on autonomic testing and MIBG scintigraphy.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start1 Sep 2018
- Primary completion1 Sep 2020
- Study completion1 Sep 2020
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 IRCCS San RaffaeleThe 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06156917
- Sponsor's protocol ID
- AIG/PD CARIPLO grant 2014-0832
- Status last verified
- Nov 2023
- First submitted
- 27 Nov 2023
- Last updated
- 5 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Autonomic, Imaging and Genetic Markers for Parkinson-related Dementia : Longitudinal Assessment of a PD Cohort.
- ClinicalTrials.gov ID
- NCT06156917
- Acronym / sponsor ID
- AIG/PD CARIPLO grant 2014-0832
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 1 Sep 2020 (actual)
- Study completion
- 1 Sep 2020 (actual)
- First posted
- 5 Dec 2023 (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.
Neuropathologically, Parkinson disease (PD) is characterized by the accumulation of intra-neuronal protein aggregates (Lewy bodies and Lewy neurites). It is believed that altered rt-synuclein protein handling plays a key role in the etiopathogenesis of PD, because it is the principal component of Lewy pathology. Recent evidence now suggests the possibility that a-synuclein is a prion-like protein and that PD is a prion-like disease. Some studies have suggested that environmental toxins promote the release of a-synuclein by enter- ic neurons and that released enteric a-synuclein is taken up by presynaptic sympathetic neurites and retro- gradely transported to the soma, where it accumulates, thus mediating the progression of PD pathology. These data indicate the precocity of autonomic nervous system involvement with reference to further spread of a-synuclein pathology. We have evidence from a previous study that the vagal preganglionic pro- jections to the gut express a-synuclein, thus providing a candidate a-synuclein-expressing pathway for the retrograde transport of pathogens to the central nervous system. Cardiovascular autonomic dysfunction explores the reactivity of sympathetic and parasympathetic pathways to a predefined set of tests, allowing to quantify the degree of dysfunction in each of the two components of the autonomic nervous system.
Mutations in the GBA gene influence the risk for dementia in PD 21; this effect of GBA is not synergistic with that of increasing age. Heterozygous GBA mutations are considered an important risk factor for PD and dementia, possibly causing a wider protein accumulation in the brain. In vitro models of alpha-synuclein aggregation have provided evidence for co-localization with mutant GBA . It has been proposed that a gain of function mechanism operates in patients with PD carrying GBA gene mutations, whereby mutant G8A promotes alpha-synuclein aggregation, accelerating Lewy body formation and neuronal loss.
Each of the selected variables provides a unique window to ascertain the association between PD patho- physiology and the risk of related dementia. Our hypothesis is that PD patients who develop incident dementia will have a number of statistically different abnormalities that will be evidenced as individual predictors and will also be assembled into a predictive algorithm. This project addresses a key issue in Parkinson disease, a progressive neurodegenerative condition, related to the assessment of variables associated to the development of dementia. The project is focused on dementia as a significant and important clinical milestone that constitutes the main cause of non-reversible functional impairment in PD patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This project provides the opportunity to collect and characterize a large cohort of PD patients to be studied prospectively. We will evaluate whether dlfferences In the measured variables exist between patients who will develop dementia (primary endpoint) within the observatlon time frame and those who will remain free from cognitive impairment at follow-up. We will compare PD patients who reach this endpoint before 10 years from disease onset to those who by that tlme remain cognitively preserved.
Key inclusion criteria (2 listed)
- Diagnosis of "clinically established PD" based on the MDS clinical diagnostic criteria.
- Age at disease onset will be between 40 and 70.
Key exclusion criteria (1 listed)
- severe autonomic dysfunction (as defined in red flag 5a and 5b) will be an exclusion criterion Previous deep brain stimulation is an exclusion criterion.
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 |
|---|---|---|
| diagnostic accuracyAims of the present project are: to investigate the relationship between incident PD dementia and multimodal parameters as cardiovascular autonomic dysfunction, altered cerebral glucose metabolism, and genetic biomarkers; development of an algorithm predictive for PD-related dementia, combining the rele- vant multidimensional parameters under study; longitudinal follow-up of clinical and cognitive status in PD patients with and without dementia along four years. | Diagnostic test | – |
Primary outcome
correlation of dysautonomia with incident dementia associated to PD
Time frame: 2 years
.At the end of the study, the patients will be divided in two groups: demented and non-demented. Dysauto- nomia measures wili be based on autonomic testing and MIBG scintigraphy.
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 5 Dec 2023.
- Individual participant dataSharing planned: No
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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, run by IRCCS San Raffaele at 1 site in Italy.
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 2 inclusion and 1 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 5 Dec 2023. 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 Italy. 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?
correlation of dysautonomia with incident dementia associated to PD (time frame: 2 years). 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 5 Dec 2023.