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FluoroAv45 Imaging Research-in Alzheimer's Disease (FAIR-AD)

Primary Purpose

Alzheimer's Disease, Mild Cognitive Impairment

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
neuropsychologic assessment
[18F]AV-45 PET
18-FDG PET
MRI
Sponsored by
University Hospital, Tours
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients suffering from Alzheimer's Disease (NINCDS-ADRDA) or from amnesic MCI
  • 18 < MMS <= 28 for patients
  • 28 <= MMS for healthy volunteers
  • study period > 7 years
  • native language : french
  • signed informed consent
  • affiliated to a social security system

Exclusion Criteria:

  • alcoholism in medical history
  • diabetes
  • arterial hypertension (180/100 and more)
  • chronical pulmonary disease with hypoxis
  • cranial traumatism with loss of consciousness > 15 minutes
  • severe depressive syndrome or anxiety
  • psychiatric disease in medical history (excepted simple episodes of depression)

Sites / Locations

  • university hospital of CAEN
  • University Hospital of Lille
  • University Hospital of Toulouse
  • University Hospital of Tours

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Alzheimer's disease

Mild Cognitive Impairment

Control

Arm Description

30 patients suffering from Alzheimer's disease

20 patients suffering from Mild Cognitive Impairment

15 subjects with no cognitive impairment

Outcomes

Primary Outcome Measures

Standard Uptake Value Ratios (SUVr)
Standard Uptake Value Ratios (SUVr) in specific regions of interest (ROI) defined by the use of the cerebellum as reference region.

Secondary Outcome Measures

Full Information

First Posted
February 21, 2011
Last Updated
February 5, 2016
Sponsor
University Hospital, Tours
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1. Study Identification

Unique Protocol Identification Number
NCT01325259
Brief Title
FluoroAv45 Imaging Research-in Alzheimer's Disease
Acronym
FAIR-AD
Official Title
Molecular Imaging of Cerebral Amyloid Plaques Using PET With Fluoro Tracker for Early Diagnosis of Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
February 2016
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2013 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Rationale: improving the early detection of AD at prodromal pre-dementia stages has become a major matter of concern. There is now an important body of literature stating that early isolated cognitive deficits (Mild Cognitive Impairment-MCI-) predict the risk of developing AD. Several biomarkers are now available : specific and sensitive neuropsychological assessments, morphometric evaluation of hippocampal volume and white matter changes by MRI, cerebrospinal fluid or plasma dosage of Ab fragments and tau proteins, assessment of brain glucose hypometabolism in temporo-parietal regions with PET [F18]FDG. However, PET imaging using labelled compounds specifically binding to APs has been suggested to improve the diagnostic reliability and to potentially help in shortening the delay until formal clinical diagnosis of AD. F18 AV45 is a new radiotracer which kinetics characteristics allows 10 to 15 minutes acquisition 50 to 60 minutes post injection. Objectives: The primary objective of the study is to compare F18 AV45 cortical uptake in AD, MCI patients and Healthy Controls. Secondary objectives will be to compare cortical uptake of F18 AV45 in MCI subject who will have convert toward dementia versus those who will not, at two year follow-up period, to compare level of 18F-AV45 cortical uptake with neuropsychological testing, PET FDG hypometabolism, ApoE genotype. Method: Prospective multicentric study. 65 patients expected to enter the study. Primary outcome measure: Standard Uptake Volume ratios.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Mild Cognitive Impairment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer's disease
Arm Type
Experimental
Arm Description
30 patients suffering from Alzheimer's disease
Arm Title
Mild Cognitive Impairment
Arm Type
Experimental
Arm Description
20 patients suffering from Mild Cognitive Impairment
Arm Title
Control
Arm Type
Experimental
Arm Description
15 subjects with no cognitive impairment
Intervention Type
Other
Intervention Name(s)
neuropsychologic assessment
Intervention Description
Mini Mental Status Examination, Mattis dementia rating scale, Geriatric Depression Scale, Edinburgh Inventory, DO 80, 12 irregular words dictation, RL-RI16, DMS 48, Rey complex figure, Stroop test, span right and reverse, praxis, ESR words, ESR drawings, Trail Making Test A and B, code test from WAIS III, Hayling inhibition test, fluences, NPI
Intervention Type
Radiation
Intervention Name(s)
[18F]AV-45 PET
Intervention Description
intravenous injection of 4 MBq/kg of [18F]AV-45
Intervention Type
Radiation
Intervention Name(s)
18-FDG PET
Intervention Description
intravenous injection of 100 to 120 MBq of FDG
Intervention Type
Other
Intervention Name(s)
MRI
Intervention Description
Magnetic Resonance Imaging
Primary Outcome Measure Information:
Title
Standard Uptake Value Ratios (SUVr)
Description
Standard Uptake Value Ratios (SUVr) in specific regions of interest (ROI) defined by the use of the cerebellum as reference region.
Time Frame
inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients suffering from Alzheimer's Disease (NINCDS-ADRDA) or from amnesic MCI 18 < MMS <= 28 for patients 28 <= MMS for healthy volunteers study period > 7 years native language : french signed informed consent affiliated to a social security system Exclusion Criteria: alcoholism in medical history diabetes arterial hypertension (180/100 and more) chronical pulmonary disease with hypoxis cranial traumatism with loss of consciousness > 15 minutes severe depressive syndrome or anxiety psychiatric disease in medical history (excepted simple episodes of depression)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent Camus
Organizational Affiliation
University Hospital of Tours
Official's Role
Principal Investigator
Facility Information:
Facility Name
university hospital of CAEN
City
Caen
ZIP/Postal Code
14000
Country
France
Facility Name
University Hospital of Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
University Hospital of Toulouse
City
Toulouse
ZIP/Postal Code
31000
Country
France
Facility Name
University Hospital of Tours
City
Tours
ZIP/Postal Code
37000
Country
France

12. IPD Sharing Statement

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FluoroAv45 Imaging Research-in Alzheimer's Disease

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