NCT02405403

Brief Summary

Neuroinflammation, characterized in particular by microglia activation, is an essential component of Amyotrophic Lateral Sclerosis (ALS) pathogenesis. Translocator Protein (TSPO) is recognized as a specific and sensitive biomarker of neuroinflammation, reflecting disease activity. An experimental radiopharmaceutical specific of TSPO expression, namely \[18F\]DPA714, allow to quantify this microglial activation using Positon Emission Tomography (PET) imaging. The purpose of this study is to longitudinally correlate the spatial distribution of neuroinflammation with the pro- or anti-inflammatory state of activated microglia cells in ALS, in order to evaluate neurotoxic or neuroprotective microglia activity, by complementary approaches in 20 ALS patients:

  • in vitro: measuring concentrations of several pro- and anti-inflammatory cytokines secreted by microglial cells in the cerebrospinal fluid (CSF).
  • in vivo: \[18F\]DPA714 PET imaging. These assays will be performed in the framework of the clinical follow-up of ALS patients, at the diagnosis of ALS disease and 6 months latter.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 1, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 31, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

March 2, 2015

Last Update Submit

May 29, 2017

Conditions

Amyotrophic Lateral Sclerosis

Keywords

amyotrophic lateral sclerosis diseasePETmicroglial activation

Outcome Measures

Primary Outcomes (1)

  • Concentration of cytokines in cerebrospinal fluid (pg/mL)

    18 months

Secondary Outcomes (1)

  • Fixation and distribution of [18F]DPA-714 (Binding Potential BP)

    18 months

Study Arms (1)

amyotrophic lateral sclerosis (ALS)

EXPERIMENTAL

\[18F\]DPA-714 PET

Drug: [18F]DPA-714 PET

Interventions

[18F]DPA-714 PETDRUG

\[18F\]DPA-714 Positron Emission Tomography

Also known as: [18F]DPA-714
amyotrophic lateral sclerosis (ALS)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Signed informed consent
  • Age ≥ 18 years old
  • Patient with probable or definite sporadic Amyotrophic Lateral Sclerosis (ALS) form according to the modified criteria of El Escorial
  • Treated with riluzole 2 weeks
  • Evolution less than 18 months
  • Mini-Mental State Examination (MMS) score ≥ 26 and Frontal Assessment Battery (FAB) (normal)
  • Affiliated to a social security system

You may not qualify if:

  • Another unbalanced progressive pathology
  • Vascular diseases (hypertension, diabetes, smoking, dyslipidemia) unbalanced
  • Forced vital capacity \<75%
  • Weight loss\> 10% of the weight before disease
  • Status "low affinity binder" or "mixed affinity binder", the TSPO respect to the \[18 F\] DPA-714, which can interfere with the process of neuroinflammation: drugs with anti-inflammatory drugs (NSAIDs, corticosteroids, azathioprine, anti-tumor necrosis factor (TNF), antibiotics)
  • Benzodiazepine in the week before the PET scan \[18F\] DPA-714 given the potential consequences for TSPO receivers
  • Contraindications to MRI in patients with:
  • Metallic foreign body eye.
  • Any implanted electronic medical irremovably (pacemaker, neurostimulator, cochlear implants ...)
  • Metal heart valve,
  • Vascular clips formerly located on cranial aneurysm.
  • Treatment in the month before the PET scan \[18F\] DPA-714 antagonist N-methyl-D-aspartate (NMDA) (memantine)
  • Pregnant women, lactating women, and women in age for procreation and without reliable contraception or without history of hysterectomy
  • ◦Person under guardianship

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital

Tours, 37044, France

Location

Related Publications (5)

  • Corcia P, Valdmanis P, Millecamps S, Lionnet C, Blasco H, Mouzat K, Daoud H, Belzil V, Morales R, Pageot N, Danel-Brunaud V, Vandenberghe N, Pradat PF, Couratier P, Salachas F, Lumbroso S, Rouleau GA, Meininger V, Camu W. Phenotype and genotype analysis in amyotrophic lateral sclerosis with TARDBP gene mutations. Neurology. 2012 May 8;78(19):1519-26. doi: 10.1212/WNL.0b013e3182553c88. Epub 2012 Apr 25.

    PMID: 22539580RESULT

  • Blasco H, Corcia P, Moreau C, Veau S, Fournier C, Vourc'h P, Emond P, Gordon P, Pradat PF, Praline J, Devos D, Nadal-Desbarats L, Andres CR. 1H-NMR-based metabolomic profiling of CSF in early amyotrophic lateral sclerosis. PLoS One. 2010 Oct 8;5(10):e13223. doi: 10.1371/journal.pone.0013223.

    PMID: 20949041RESULT

  • Arlicot N, Vercouillie J, Ribeiro MJ, Tauber C, Venel Y, Baulieu JL, Maia S, Corcia P, Stabin MG, Reynolds A, Kassiou M, Guilloteau D. Initial evaluation in healthy humans of [18F]DPA-714, a potential PET biomarker for neuroinflammation. Nucl Med Biol. 2012 May;39(4):570-8. doi: 10.1016/j.nucmedbio.2011.10.012. Epub 2011 Dec 14.

    PMID: 22172392RESULT

  • Corcia P, Ingre C, Blasco H, Press R, Praline J, Antar C, Veyrat-Durebex C, Guettard YO, Camu W, Andersen PM, Vourc'h P, Andres CR. Homozygous SMN2 deletion is a protective factor in the Swedish ALS population. Eur J Hum Genet. 2012 May;20(5):588-91. doi: 10.1038/ejhg.2011.255. Epub 2012 Jan 25.

    PMID: 22274580RESULT

  • Corcia P, Tauber C, Vercoullie J, Arlicot N, Prunier C, Praline J, Nicolas G, Venel Y, Hommet C, Baulieu JL, Cottier JP, Roussel C, Kassiou M, Guilloteau D, Ribeiro MJ. Molecular imaging of microglial activation in amyotrophic lateral sclerosis. PLoS One. 2012;7(12):e52941. doi: 10.1371/journal.pone.0052941. Epub 2012 Dec 31.

    PMID: 23300829RESULT

MeSH Terms

Conditions

Amyotrophic Lateral Sclerosis

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesMotor Neuron DiseaseNeurodegenerative DiseasesTDP-43 ProteinopathiesNeuromuscular DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Philippe CORCIA, PhD

    CHRU TOURS

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 2, 2015

First Posted

April 1, 2015

Study Start

March 1, 2015

Primary Completion

September 1, 2016

Study Completion

March 1, 2017

Last Updated

May 31, 2017

Record last verified: 2017-05

Locations

FR(1)