Neuroinflammation and Cognitive Decline in Alzheimer Disease (NICAD)

September 8, 2022 updated by: University Hospital, Tours

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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)

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44000
        • University Hospital of Nantes
      • Rennes, France, 35000
        • University Hospital of Rennes
      • Tours, France, 37044
        • University Hospital of Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alzheimer Disease
Alzheimer Disease People ADAS-Cog evaluation PET imaging with [18F]DPA-714
Other: ADAS-Cog evaluation
[18F]DPA-714 PET imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
inclusion and 24 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Relationship passessment between [18F]DPA-714 fixing
Time Frame: Inclusion and 34 months
Inclusion and 34 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Tours

Investigators

  • Principal Investigator: Vincent CAMUS, PhD, University Hospital of Tours

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2016

Primary Completion (Actual)

December 4, 2019

Study Completion (Actual)

December 4, 2019

Study Registration Dates

First Submitted

February 17, 2015

First Submitted That Met QC Criteria

February 24, 2015

First Posted (Estimate)

March 3, 2015

Study Record Updates

Last Update Posted (Actual)

September 14, 2022

Last Update Submitted That Met QC Criteria

September 8, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRTS13-CH / NICAD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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