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

February 5, 2016 updated by: University Hospital, Tours

Molecular Imaging of Cerebral Amyloid Plaques Using PET With Fluoro Tracker for Early Diagnosis of Alzheimer's Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2

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
      • Caen, France, 14000
        • University Hospital of Caen
      • Lille, France, 59000
        • University Hospital of Lille
      • Toulouse, France, 31000
        • University Hospital of Toulouse
      • Tours, France, 37000
        • 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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

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: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alzheimer's disease
30 patients suffering from Alzheimer's disease
Other: MRI
Magnetic Resonance Imaging
Other: neuropsychologic assessment
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
Radiation: [18F]AV-45 PET
intravenous injection of 4 MBq/kg of [18F]AV-45
Radiation: 18-FDG PET
intravenous injection of 100 to 120 MBq of FDG
Experimental: Mild Cognitive Impairment
20 patients suffering from Mild Cognitive Impairment
Other: MRI
Magnetic Resonance Imaging
Other: neuropsychologic assessment
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
Radiation: [18F]AV-45 PET
intravenous injection of 4 MBq/kg of [18F]AV-45
Radiation: 18-FDG PET
intravenous injection of 100 to 120 MBq of FDG
Experimental: Control
15 subjects with no cognitive impairment
Other: MRI
Magnetic Resonance Imaging
Other: neuropsychologic assessment
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
Radiation: [18F]AV-45 PET
intravenous injection of 4 MBq/kg of [18F]AV-45
Radiation: 18-FDG PET
intravenous injection of 100 to 120 MBq of FDG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard Uptake Value Ratios (SUVr)
Time Frame: inclusion
Standard Uptake Value Ratios (SUVr) in specific regions of interest (ROI) defined by the use of the cerebellum as reference region.
inclusion

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, University Hospital of Tours

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

April 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2013

Study Registration Dates

First Submitted

February 21, 2011

First Submitted That Met QC Criteria

March 28, 2011

First Posted (Estimate)

March 29, 2011

Study Record Updates

Last Update Posted (Estimate)

February 8, 2016

Last Update Submitted That Met QC Criteria

February 5, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHRN08-VC / FAIR AD

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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