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Clinical Trials/NCT02062099
NCT02062099
Completed
Phase 1

PET Imaging of the Translocator Proteine Ligands (TSPO) With [18 F] DPA-714 Biomarker of NeuroInflammation in Cognitive Decline (NIDECO)

University Hospital, Tours1 site in 1 country25 target enrollmentJanuary 2014

Overview

Phase
Phase 1
Intervention
[18F]DPA-714 PET/ [18F]AV-45 PET/neuropsychological assessment
Conditions
Memory Complaint
Sponsor
University Hospital, Tours
Enrollment
25
Locations
1
Primary Endpoint
Fixation and distribution of [18F]DPA-714 (Binding Potential BP)
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Alzheimer's disease (AD) is the most common cause of dementia in elderly subjects. AD is characterized by brain lesions like extracellular deposits of ß-amyloïd proteins in senile plaques and intracellular neurofibrillary tangles of hyper-phosphorylated tau protein, both of which are associated with the loss of neurons. The development of disease biomarkers for AD (Tau, PhTau and βamyloid dosing in the cerebrospinal fluid, brain MRI, amyloid PET imaging and fluorodeoxyglucose PET imaging) to identify the pathophysiological processes underlying cognitive impairment biomarkers, have been incorporated into revised diagnosis guidelines.

Post-mortem human AD and AD animal model studies have reported inflammatory processes also implicated in the neuropathology of AD, and upregulated levels of pro-inflammatory cytokines.

In vivo visualization of microglial activation has become possible with the development of molecular imaging ligands (tracers) for use with positron emission tomography (PET). The translocator protein (TSPO) formerly known as the peripheral benzodiazepine receptor (PBR), a receptor located in the outer membrane of mitochondria, is upregulated during neuroinflammation. So targeting TSPO with radiolabeled ligands for PET is considered as an attractive biomarker for neuroinflammation.

The main aim of this pilot study is to quantify neuroinflammation, in terms of fixation and distribution of [18F] DPA-714(Binding Potential BP), and to study its relationship with amyloid load, measured with in [18F]AV-45 (Standard Uptake Values ratio) in cognitive decline.

Detailed Description

Molecular imaging of microglial activation could help us document the central inflammatory status of study subjects and assist us in designing future research studies particularly with respect to which subjects to enrol into clinical trials and to evaluate the benefit of specific therapies in selected groups, for example, by monitoring the effects of Aß immunization.

Registry
clinicaltrials.gov
Start Date
January 2014
End Date
May 22, 2018
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Criteria common to all participants:
  • Signed informed consent
  • Age ≥ 60 years old (60-80 years old)
  • Native language: French
  • Correct sensory abilities (hearing aids accepted) to perform the tests
  • Affiliated to a social security system
  • Criteria for patients with mild to moderate Alzheimer disease defined according to the NINCDS-ADRDA {McKhann, 2011 # 408}:
  • MMS between 20 and 25
  • contraindication for MRI
  • Criteria for amnestic MCI patients:

Exclusion Criteria

  • Not provided

Arms & Interventions

Memory complaint /MCI/ mild to moderate MA

Memory complaint (without cognitive decline): 12 patients/ Mild Cognitive Impairment: 12 patients/ Mild to moderate Alzheimer Disease: 12 patients

Intervention: [18F]DPA-714 PET/ [18F]AV-45 PET/neuropsychological assessment

Outcomes

Primary Outcomes

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

Time Frame: 2 years

[18F]AV-45 Standard Uptake Values ratio

Time Frame: 2 years

Secondary Outcomes

  • Relationship between [18F]DPA-714 uptake and cognitive, affective symptoms at baseline.(2 years)

Study Sites (1)

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