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Completed

NCT Number: NCT02377206

Neuroinflammation and Cognitive Decline in Alzheimer Disease

The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714, and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) and Mini-Mental State Examination (MMSE) scores).

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

university hospital of Nantes, Nantes, France

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About this study

The purpose of this study is to assess the level of neuroinflammation in Alzheimer Disease subject (mild to moderate) estimated with Binding Potential (BP) of [18F]DPA-714 , and its relationship with the kinetics of cognitive decline over a 24-month follow-up period (as assessed by ADAS-Cog and MMSE scores).

(DPA-714 : N,N-diethyl-2-[4-(2-fluoroethoxy)phenyl]-5,7-dimethylpyrazolo[1,5-a]pyrimidine-3-acetamide)

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Informed consent
  • Age more than 50 years (included)
  • necessary knowledge of French (write and oral) to do neuropsychological tests
  • Study level upper (or equal) than 7 years (considering first year of grammar-school as start)
  • People with Alzheimer Disease defined as National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) and the Alzheimer's Disease and Related Disorders Association (ADRDA) standards : Light to mild AD defined by Mini-Mental State Examination (MMSE) score between 15 and 25 (included)
  • Social security affiliation.

Exclusion criteria

  • MMSE score lower than 15 and upper or equal to 26
  • Evolutive disease which could possibly had consequences on central nervous system
  • Inflammatory disease or evolutive neoplasia and/or C reactive protein (CRP) upper than 10mg/L
  • Chronic use of alchohol and/or drug
  • Serious depression defined by Montgomery Asberg Depression Rating Scale (MADRS) score higher than 18
  • Surgical or medical condition in the last 3 months
  • Long term treatment which could possibly interfere with inflammatory process (especially the month before PET [18F]DPA-714 imaging).
  • Treatment by N-Methyl-D-Aspartate antagonist
  • Treatment by Minocycline
  • Treatment by benzodiazepine (especially the month before PET [18F]DPA-714 imaging) (Zolpidem, zopiclone and loprazolam excepted)
  • Anomaly at neurological examination which is not a classical symptom
  • Contraindication to magnetic resonance imaging (RMI)
  • Florbetapir[18F] hypersensibility
  • Participation to an other experimental protocol with drug.
  • people under guardianship

Treatment and study plan

ADAS-Cog evaluation

Other

[18F]DPA-714 PET imaging

Primary outcomes

  1. Compare the neuroinflammation measured by fixing and layout of [18F]DPA-714 between 3 groups of patients : subjects suffering from Alzheimer disease light to mild stage, amnesiac MCI and patients suffering from isolated cognitive complaint

    Time frame: inclusion and 24 months

Secondary outcomes

  1. Relationship passessment between [18F]DPA-714 fixing

    Time frame: Inclusion and 34 months

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Registry information

Official study title

Neuroinflammation and Cognitive Decline in Alzheimer Disease (AD) : Pilot Study of Translocator Proteins Ligand PET Imaging With [18F]DPA-714

Acronym: NICAD

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
Mar 3, 2015
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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