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NCT Number: NCT02062099

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

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.

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Key information

Conditions

Memory Complaint Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University Hospital of Tours

Tours, 37000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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:

  • Amnestic mildcognitive disorder evoking a MA in pre stage dementia {Dubois, 2010 # 273, Dubois, 2007 # 42; Pertersen, 1999 # 21, Albert, 2011 # 409} older than 60 years.

Criteria for patients with isolated memory Complaint (Without Cognitive Decline):

  • MMS score ≥ 26
  • Normal performance by age and educational level

No inclusion criteria :

  • medical history of evolutive disease with conséquences on NCS, chronic alcohol intake, severe depression with MADRS stage > 18
  • MA subjects : antagonistic treatment with N-methyl-D-aspartate
  • MA or MCI subjects : anomaly on neurologic clinical examination different of the usual symptomatology

Treatment and study plan

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

Drug

Primary outcomes

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

    Time frame: 2 years

  2. [18F]AV-45 Standard Uptake Values ratio

    Time frame: 2 years

Secondary outcomes

  1. Relationship between [18F]DPA-714 uptake and cognitive, affective symptoms at baseline.

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Acronym: NIDeCo

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Feb 13, 2014
Registry last updated
Sep 14, 2022

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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