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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01325259
First received: February 21, 2011
Last updated: February 5, 2016
Last verified: February 2016
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Mild Cognitive Impairment
Other: neuropsychologic assessment
Radiation: [18F]AV-45 PET
Radiation: 18-FDG PET
Other: MRI
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Molecular Imaging of Cerebral Amyloid Plaques Using PET With Fluoro Tracker for Early Diagnosis of Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Tours:

Primary Outcome Measures:
  • Standard Uptake Value Ratios (SUVr) [ Time Frame: inclusion ] [ Designated as safety issue: No ]
    Standard Uptake Value Ratios (SUVr) in specific regions of interest (ROI) defined by the use of the cerebellum as reference region.


Enrollment: 54
Study Start Date: April 2009
Study Completion Date: December 2013
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alzheimer's disease
30 patients suffering from Alzheimer's disease
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
Other: MRI
Magnetic Resonance Imaging
Experimental: Mild Cognitive Impairment
20 patients suffering from Mild Cognitive Impairment
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
Other: MRI
Magnetic Resonance Imaging
Experimental: Control
15 subjects with no cognitive impairment
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
Other: MRI
Magnetic Resonance Imaging

  Eligibility

Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325259

Locations
France
university hospital of CAEN
Caen, France, 14000
University Hospital of Lille
Lille, France, 59000
University Hospital of Toulouse
Toulouse, France, 31000
University Hospital of Tours
Tours, France, 37000
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Vincent Camus University Hospital of Tours
  More Information

Responsible Party: University Hospital, Tours
ClinicalTrials.gov Identifier: NCT01325259     History of Changes
Other Study ID Numbers: PHRN08-VC / FAIR AD 
Study First Received: February 21, 2011
Last Updated: February 5, 2016
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Alzheimer Disease
Cognition Disorders
Mild Cognitive Impairment
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 23, 2016