Parkinson DiseaseICEBERGNCT02305147
Cohort Study to Identify Predictor Factors of Onset and Progression of Parkinson's Disease
An observational study of Parkinson Disease, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
Trial summary
Observational, prospective, monocentric study to assess clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients and rate of progression compared to healthy controls (HC) and subjects at risk to develop PD. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Clinical, biological and imaging followup
- How many people
- 385 participants
- Where
- 1 siteFrance
- Study dates
- 6 Nov 2014to 5 Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with recent onset of Parkinson Disease (less than 3 years since diagnosis) compared to subjects at risk to develop Parkinson Disease and healthy controls
Who may be able to join
- All subjects: Male or female age 18 years and older, MMSE score > 26, negative pregnancy test in potentially child-bearing women (contraindication to SPECT with DatScan).
- Idiopathic Parkinson disease subjects: diagnosis confirmed according to UK Parkinson's Disease Society Brain Bank criteria (UKPDSBB); disease duration less than 3 years.
- Genetic Parkinson disease subjects: parkinson diagnosis confirmed and mutation in parkin, LRRK2, SNCA or GBA genes.
- Prodromal subjects: subjects with identified relative with PD genetically confirmed or subjects with diagnosis of idiopathic Rem sleep Behavior Disorder (iRBD); neurological examination normal (no signs of parkinsonism).
- Healthy subjects: neurological examination normal
Who cannot join
- All subjects: Psychiatric disorder or any progressive life-threatening disease, impairment precluding appropriate information and instructions given concerning participation to the study; contra-indication to MRI or SPECT scan.
- Parkinson disease subjects: no dopamine transporter deficit at SPECT scan; parkinsonism induced by neuroleptics; neuroleptics intake within 6 months; atypical parkinson syndrom (MSA, PSP, CBD...)
- Parkinson disease subjects with mutation in Parkin, LRRK2, SNCA or GBA gene: atypical parkinson disease syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy) or currently taking neuroleptics or has taken neuroleptics within 6 months of baseline or any biological anomaly.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Etude Des Facteurs prédictifs de l'Apparition et de l'évolution de la Maladie de Parkinson
Observational, prospective, monocentric study to assess clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients and rate of progression compared to healthy controls (HC) and subjects at risk to develop PD.
The primary objective of this study is to identify clinical, imaging and biologic markers of PD onset and progression for use in clinical trials of disease-modifying therapies.
Read the detailed description
ICEBERG will be a four-year natural history study of de novo idiopathic PD patients, healthy controls, and subjects at risk to develop PD (idiopathic Rem Behavior Disorder -iRBD, and probants of patients with PD genetically confirmed).
All subjects will be comprehensively assessed at baseline and every year thereafter. Subjects will undergo clinical (motor, neuropsychiatric, sleep, ocular and cognitive evaluations) and imaging assessments. Blood (including a DNA sample), stools, skin biopsy and cerebral spinal fluid (CSF) samples will be collected.
- Conditions
- Parkinson Disease
- Being tested
- Clinical, biological and imaging followup
- Keywords
- Parkinson Disease, Biomarkers, Prognostic factors, Prodromal features, Disease progression
- Medical subject headings
- Parkinson Disease, Disease Progression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical, biological and imaging followupOther
Assessment of motor and non motor signs every 12 months. Imaging and blood, cerebral fluid, stools and skin samples for identification of biomarkers of disease phenotype and progression.
| Study group | Role | What they receive |
|---|---|---|
| Patients with an idiopathic Parkinson Disease, | Patients with recent onset of Parkinson Disease: N=200 | |
| Subjects at risk of PD | Subjects at risk to develop Parkinson Disease:
* subjects with idiopathic Rem-sleep behavior disorder (iRBD): N=50
* subjects related to a patient with genetically confirmed Parkinson Disease: N=30 Receives: Other: Clinical, biological and imaging followup | |
| Controls | Healthy controls: N=50 Receives: Other: Clinical, biological and imaging followup | |
| Patients with Parkinson Disease with genetic mutation | Patients with Parkinson Disease with a genetic mutation in parkin, LRRK2, SNCA or GBA (N=30) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rates of change of clinical, imaging and biomic outcomes
Slopes of change of clinical, imaging and biomics compared between PD patients, subjects at risk to develop PD and healthy subjects.
Identification of predictive factors of these rates of change. As examples, outcomes include: MDS-UPDRS, Mattis dementia rating scale, Non Motor Signs scale, DAT striatal uptake.
Measured: 4 years (annual visits)
Secondary outcomes (3)
Clinical milestones in PD patients
Occurence of complications such as falls, freezing, dyskinesias, motor fluctuations, cognitive impairment, dysautonomia.
Identification of predictive factors of these complications. Rates of progression in sub-groups of patients defined by the presence of these complications.
Measured: 4 years (annual visits)
Prodromal features in subjects at risk to develop PD
Prodromal features such as anosmia, dysautonomia, color vision impairment, will be evaluated at inclusion and during followup in subjects with iRBD or first-degree relatives of genetically confirmed PD patients.
Frequency of these features will be compared between subjects who phenoconvert and those who don't.
Relation between baseline DatSCAN binding and risk of phenoconversion will be analysed.
Measured: 4 years (annual visits)
Phenoconversion in subjects at risk to develop PD
Phenoconversion is defined as occurence of an extrapyramidal syndrome, confirmed 12 months later.
Exploratory analysis to determine whether rates of progression clinical, imaging and biomic markers may predict phenoconversion in groups of patients with iRBD or probants of patients with PD genetically confirmed.
Measured: 4 years (annual visits)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study start6 Nov 2014
- Primary completion5 Nov 2029 (estimated)
- Study completion5 Nov 2029 (estimated)
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 Institut National de la Santé Et de la Recherche Médicale, FranceThe 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
- 385 participants (actual)
Sponsor and investigators
- Sponsor type
- Other government
- Collaborators
- IHU-A-ICM, Paris, France
- Responsible party
- Sponsor
- Investigators
- Marie VIDAILHET, PhD, Principal investigator, Assistance Publique - Hôpitaux de ParisJean-Christophe CORVOL, PhD, Study chair, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305147
- Sponsor's protocol ID
- C13-74
- Acronym
- ICEBERG
- Status last verified
- Jul 2026
- First submitted
- 10 Oct 2014
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Etude Des Facteurs prédictifs de l'Apparition et de l'évolution de la Maladie de Parkinson
- ClinicalTrials.gov ID
- NCT02305147
- Acronym / sponsor ID
- ICEBERG / C13-74
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, Biomarkers, Prognostic factors, Prodromal features, Disease progression
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Institut National de la Santé Et de la Recherche Médicale, FranceOther government
- Collaborators
- IHU-A-ICM, Paris, France
- Study start
- 6 Nov 2014 (actual)
- Primary completion
- 5 Nov 2029 (estimated)
- Study completion
- 5 Nov 2029 (estimated)
- First posted
- 2 Dec 2014 (estimated)
- 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.
Observational, prospective, monocentric study to assess clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients and rate of progression compared to healthy controls (HC) and subjects at risk to develop PD.
The primary objective of this study is to identify clinical, imaging and biologic markers of PD onset and progression for use in clinical trials of disease-modifying therapies.
Detailed description
ICEBERG will be a four-year natural history study of de novo idiopathic PD patients, healthy controls, and subjects at risk to develop PD (idiopathic Rem Behavior Disorder -iRBD, and probants of patients with PD genetically confirmed).
All subjects will be comprehensively assessed at baseline and every year thereafter. Subjects will undergo clinical (motor, neuropsychiatric, sleep, ocular and cognitive evaluations) and imaging assessments. Blood (including a DNA sample), stools, skin biopsy and cerebral spinal fluid (CSF) samples will be collected.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients with an idiopathic Parkinson Disease, | – | –Patients with recent onset of Parkinson Disease: N=200 |
| Subjects at risk of PD | – | Other: Clinical, biological and imaging followupSubjects at risk to develop Parkinson Disease: * subjects with idiopathic Rem-sleep behavior disorder (iRBD): N=50 * subjects related to a patient with genetically confirmed Parkinson Disease: N=30 |
| Controls | – | Other: Clinical, biological and imaging followupHealthy controls: N=50 |
| Patients with Parkinson Disease with genetic mutation | – | –Patients with Parkinson Disease with a genetic mutation in parkin, LRRK2, SNCA or GBA (N=30) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with recent onset of Parkinson Disease (less than 3 years since diagnosis) compared to subjects at risk to develop Parkinson Disease and healthy controls
Key inclusion criteria (5 listed)
- All subjects: Male or female age 18 years and older, MMSE score > 26, negative pregnancy test in potentially child-bearing women (contraindication to SPECT with DatScan).
- Idiopathic Parkinson disease subjects: diagnosis confirmed according to UK Parkinson's Disease Society Brain Bank criteria (UKPDSBB); disease duration less than 3 years.
- Genetic Parkinson disease subjects: parkinson diagnosis confirmed and mutation in parkin, LRRK2, SNCA or GBA genes.
- Prodromal subjects: subjects with identified relative with PD genetically confirmed or subjects with diagnosis of idiopathic Rem sleep Behavior Disorder (iRBD); neurological examination normal (no signs of parkinsonism).
- Healthy subjects: neurological examination normal
Key exclusion criteria (3 listed)
- All subjects: Psychiatric disorder or any progressive life-threatening disease, impairment precluding appropriate information and instructions given concerning participation to the study; contra-indication to MRI or SPECT scan.
- Parkinson disease subjects: no dopamine transporter deficit at SPECT scan; parkinsonism induced by neuroleptics; neuroleptics intake within 6 months; atypical parkinson syndrom (MSA, PSP, CBD...)
- Parkinson disease subjects with mutation in Parkin, LRRK2, SNCA or GBA gene: atypical parkinson disease syndromes due to either drugs (e.g., metoclopramide, flunarizine, neuroleptics) or metabolic disorders (e.g., Wilson's disease), encephalitis or degenerative diseases (e.g., progressive supranuclear palsy) or currently taking neuroleptics or has taken neuroleptics within 6 months of baseline or any biological anomaly.
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 |
|---|---|---|
| Clinical, biological and imaging followupAssessment of motor and non motor signs every 12 months. Imaging and blood, cerebral fluid, stools and skin samples for identification of biomarkers of disease phenotype and progression. | Other | Controls, Subjects at risk of PD |
Primary outcome
Rates of change of clinical, imaging and biomic outcomes
Time frame: 4 years (annual visits)
Slopes of change of clinical, imaging and biomics compared between PD patients, subjects at risk to develop PD and healthy subjects. Identification of predictive factors of these rates of change. As examples, outcomes include: MDS-UPDRS, Mattis dementia rating scale, Non Motor Signs scale, DAT striatal uptake.
3 secondary outcomes
Clinical milestones in PD patients
Time frame: 4 years (annual visits)
Prodromal features in subjects at risk to develop PD
Time frame: 4 years (annual visits)
Phenoconversion in subjects at risk to develop PD
Time frame: 4 years (annual visits)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
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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.
Marie VIDAILHET, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
Jean-Christophe CORVOL, PhD study chair
Assistance Publique - Hôpitaux de Paris
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 Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
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?
Rates of change of clinical, imaging and biomic outcomes (time frame: 4 years (annual visits)). 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 Jul 2026.