ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 26 of 2289 for:    alzheimer disease

Neuroinflammation and Cognitive Decline in Alzheimer Disease (NICAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02377206
Recruitment Status : Unknown
Verified June 2015 by University Hospital, Tours.
Recruitment status was:  Recruiting
First Posted : March 3, 2015
Last Update Posted : June 23, 2015
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Alzheimer Disease Other: ADAS-Cog evaluation Phase 1

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  (Clinical Trial)
Estimated Enrollment : 45 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Neuroinflammation and Cognitive Decline in Alzheimer Disease (AD) : Pilot Study of Translocator Proteins Ligand PET Imaging With [18F]DPA-714
Study Start Date : March 2015
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : March 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  1. Change from baseline in ADAS-Cog score [ Time Frame: inclusion, 6 - 12 and 24 months ]
    Score of the ADAS-Cog test


Secondary Outcome Measures :
  1. Quantification of neuroinflammation by [18F]DPA-714 PET imaging [ Time Frame: Inclusion ]
    Binding potential of [18F]DPA-714 in PET Imaging



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   60 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Informed consent
  • Age between 60 and 85 year (included)
  • necessary knowledge of French (write and oral) to do neuropsychological tests
  • Study level upper (or equal) than 7 year (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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02377206


Contacts
Contact: Caroline Hommet, PhD +33247479780 caroline.hommet@univ-tours.fr
Contact: Catherine Roussel +3347479789 catherine.roussel@univ-tours.fr

Locations
France
University hospital of Caen Not yet recruiting
Caen, France, 14000
Contact: Sylvie Brucato    +332 31 06 43 87    brucato-s@chu-caen.fr   
Contact: Vincent De la Sayette, PhD    +333 21 06 49 99    delasayette-v@chu-caen.fr   
Principal Investigator: Vincent De La Sayette, PhD         
Sub-Investigator: Louisa Barre, PhD         
Sub-Investigator: Alain Manrique, PhD         
university hospital of Nantes Not yet recruiting
Nantes, France, 44000
Contact: Tiphaine Charriau    +332 40 16 52 81    tiphaine.charriau@chu-nantes.fr   
Contact: Claire Boutoleau bretonnière, PhD    +332 40 16 54 22    claire.boutoleaubretonniere@chu-nantes.fr   
Principal Investigator: Claire Boutoleau bretonnière, PhD         
Sub-Investigator: Gilles Berrut, PhD         
Sub-Investigator: Amandine Pallardy, PhD         
University Hospital of Rennes Not yet recruiting
Rennes, France, 35000
Contact: Nicoles Belliard    +332 99 87 30 26    nicole.belliard@chu-rennes.fr   
Contact: Dominique Somme, PhD    +332 99 28 41 10    Dominique.SOMME@chu-rennes.fr   
Principal Investigator: Dominique Somme, PhD         
Sub-Investigator: Aline Corvol, PhD         
Sub-Investigator: Florence Lejeune, PhD         
Sub-Investigator: Serge Belliard, PhD         
University Hospital of Tours Recruiting
Tours, France, 37044
Contact: Julien Boucheron    +33218370597    j.boucheron@chu-tours.fr   
Contact: Catherine Roussel    +3347479789    catherine.roussel@univ-tours.fr   
Principal Investigator: Caroline Hommet, PhD         
Sub-Investigator: Vincent Camus         
Sub-Investigator: Karl Mondon         
Sub-Investigator: Emilie Beaufils         
Sub-Investigator: Maria-Joao Santiago-Ribeiro         
Sub-Investigator: Valérie Gissot         
Sub-Investigator: jean-Philippe Cottier         
Sub-Investigator: Frédéric Patat         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Caroline Hommet, PhD University Hospital of Tours