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NCT Number: NCT02305147

Cohort Study to Identify Predictor Factors of Onset and Progression of Parkinson's Disease

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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Disease Attributes Disease Progression Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Pitié-Salpêtrière

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Clinical, biological and imaging followup

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Clinical milestones in PD patients

    Time frame: 4 years (annual visits)

    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.

  2. Prodromal features in subjects at risk to develop PD

    Time frame: 4 years (annual visits)

    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.

  3. Phenoconversion in subjects at risk to develop PD

    Time frame: 4 years (annual visits)

    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.

Sponsors and collaborators

Lead sponsor

Institut National de la Santé Et de la Recherche Médicale, France

Other Gov

Collaborators

  • IHU-A-ICM, Paris, France

Registry information

Official study title

Etude Des Facteurs prédictifs de l'Apparition et de l'évolution de la Maladie de Parkinson

Acronym: ICEBERG

Important dates

Study start
2014
Primary completion
2029
Study completion
2029
First posted
Dec 2, 2014
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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