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Neuroinflammation and Cognitive Decline in Alzheimer Disease (NICAD)

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Early Phase 1
Locations
France
Study Type
Interventional
Intervention
ADAS-Cog evaluation
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring PET, [18F]DPA-714, cognitive decline

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • university hospital of Nantes
  • University Hospital of Rennes
  • University Hospital of Tours

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Alzheimer Disease

Arm Description

Alzheimer Disease People ADAS-Cog evaluation PET imaging with [18F]DPA-714

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Relationship passessment between [18F]DPA-714 fixing

Full Information

First Posted
February 17, 2015
Last Updated
September 8, 2022
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT02377206
Brief Title
Neuroinflammation and Cognitive Decline in Alzheimer Disease
Acronym
NICAD
Official Title
Neuroinflammation and Cognitive Decline in Alzheimer Disease (AD) : Pilot Study of Translocator Proteins Ligand PET Imaging With [18F]DPA-714
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
April 6, 2016 (Actual)
Primary Completion Date
December 4, 2019 (Actual)
Study Completion Date
December 4, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Tours

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).
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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
PET, [18F]DPA-714, cognitive decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer Disease
Arm Type
Experimental
Arm Description
Alzheimer Disease People ADAS-Cog evaluation PET imaging with [18F]DPA-714
Intervention Type
Other
Intervention Name(s)
ADAS-Cog evaluation
Intervention Description
[18F]DPA-714 PET imaging
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Relationship passessment between [18F]DPA-714 fixing
Time Frame
Inclusion and 34 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent CAMUS, PhD
Organizational Affiliation
University Hospital of Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
university hospital of Nantes
City
Nantes
ZIP/Postal Code
44000
Country
France
Facility Name
University Hospital of Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37044
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
21911694
Citation
Schmidt C, Wolff M, Weitz M, Bartlau T, Korth C, Zerr I. Rapidly progressive Alzheimer disease. Arch Neurol. 2011 Sep;68(9):1124-30. doi: 10.1001/archneurol.2011.189.
Results Reference
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PubMed Identifier
19043645
Citation
Soto ME, Andrieu S, Arbus C, Ceccaldi M, Couratier P, Dantoine T, Dartigues JF, Gillette-Guyonnet S, Nourhashemi F, Ousset PJ, Poncet M, Portet F, Touchon J, Vellas B. Rapid cognitive decline in Alzheimer's disease. Consensus paper. J Nutr Health Aging. 2008 Dec;12(10):703-13. doi: 10.1007/BF03028618.
Results Reference
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PubMed Identifier
17215578
Citation
Helmer C, Andrieu S, Peres K, Orgogozo JM, Vellas B, Dartigues JF; REAL.fr Group. Predictive value of 6-month decline in ADAS-cog for survival without severe Alzheimer's disease. Dement Geriatr Cogn Disord. 2007;23(3):168-74. doi: 10.1159/000098516. Epub 2007 Jan 11.
Results Reference
background
PubMed Identifier
22972646
Citation
Lo RY, Jagust WJ; Alzheimer's Disease Neuroimaging Initiative. Vascular burden and Alzheimer disease pathologic progression. Neurology. 2012 Sep 25;79(13):1349-55. doi: 10.1212/WNL.0b013e31826c1b9d. Epub 2012 Sep 12.
Results Reference
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Neuroinflammation and Cognitive Decline in Alzheimer Disease

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