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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2011 by University Hospital, Tours.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01325259
First received: February 21, 2011
Last updated: March 28, 2011
Last verified: March 2011
  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 Disorder
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) [ 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.


Estimated Enrollment: 65
Study Start Date: April 2009
Estimated Study Completion Date: December 2012
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
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

Contacts
Contact: Vincent Camus, MD +33 247 47 91 30 camus@med.univ-tours.fr
Contact: Valérie Gissot, MD +33 234 37 96 53 valerie.gissot@univ-tours.fr

Locations
France
university hospital of CAEN Recruiting
Caen, France, 14000
Contact: Vincent De La SAYETTE, MD    +33 2 31 06 49 99    delasayette-v@chu-caen.fr   
Principal Investigator: vincent De la Sayette, MD         
Sub-Investigator: Francis Eustache, MD         
Sub-Investigator: Gaël Chatelat, MD         
Sub-Investigator: Alain Manrique, MD         
Sub-Investigator: Louisa Barre, MD         
Sub-Investigator: Béatrice Desgranges, MD         
University Hospital of Lille Recruiting
Lille, France, 59000
Contact: Franck Semah, MD    +33 3 20 44 64 19      
Principal Investigator: Franck Semah, MD         
Sub-Investigator: Florence Pasquier, MD         
Sub-Investigator: Claude Hossein-Foucher, MD         
Sub-Investigator: Florence Le Jeune, MD         
Sub-Investigator: Grégory Petyt, MD         
Sub-Investigator: Adeline Rollin-Sillaire, MD         
Sub-Investigator: Stephanie Bombois, MD         
Sub-Investigator: Marie-Anne Mackowiak, MD         
Sub-Investigator: Marion Paulin, MD         
Sub-Investigator: Pascaline Cassagnaud, MD         
University Hospital of Toulouse Recruiting
Toulouse, France, 31000
Contact: Pierre Payoux, MD    +33 5 61 77 21 29      
Principal Investigator: Pierre Payoux, MD         
Sub-Investigator: Bruno Vellas, MD         
Sub-Investigator: Pierre-Jean Ousset, MD         
Sub-Investigator: Thierry Voisin, MD         
Sub-Investigator: Nathalie Sastre-Hengan, MD         
Sub-Investigator: Anne Hitzel, MD         
Sub-Investigator: Julien Delrieu, MD         
University Hospital of Tours Recruiting
Tours, France, 37000
Contact: Centre d'Investigation Clinique    +33 2 47 47 69 72    cic.ide@chu-tours.fr   
Principal Investigator: Vincent Camus, MD         
Sub-Investigator: Valérie Gissot, MD         
Sub-Investigator: Caroline Hommet, MD         
Sub-Investigator: Karl Mondon, MD         
Sub-Investigator: Luc ZAWADZKI, MD         
Sub-Investigator: Denis Guilloteau         
Sub-Investigator: Jean-Philippe COTTIER, MD         
Sub-Investigator: jean-louis BEAULIEU, MD         
Sub-Investigator: Maria Joao SANTIAGO RIBEIRO, MD         
Sub-Investigator: yann VENEL, MD         
Sponsors and Collaborators
University Hospital, Tours
Investigators
Principal Investigator: Vincent Camus University Hospital of Tours
  More Information

No publications provided

Responsible Party: Vincent CAMUS, MD, University Hospital of Tours
ClinicalTrials.gov Identifier: NCT01325259     History of Changes
Other Study ID Numbers: PHRN08-VC / FAIR AD
Study First Received: February 21, 2011
Last Updated: March 28, 2011
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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 29, 2014