Study Results
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Basic Information
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COMPLETED
PHASE2
54 participants
INTERVENTIONAL
2009-04-30
2013-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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Alzheimer's disease
30 patients suffering from Alzheimer's disease
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
[18F]AV-45 PET
intravenous injection of 4 MBq/kg of \[18F\]AV-45
18-FDG PET
intravenous injection of 100 to 120 MBq of FDG
MRI
Magnetic Resonance Imaging
Mild Cognitive Impairment
20 patients suffering from Mild Cognitive Impairment
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
[18F]AV-45 PET
intravenous injection of 4 MBq/kg of \[18F\]AV-45
18-FDG PET
intravenous injection of 100 to 120 MBq of FDG
MRI
Magnetic Resonance Imaging
Control
15 subjects with no cognitive impairment
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
[18F]AV-45 PET
intravenous injection of 4 MBq/kg of \[18F\]AV-45
18-FDG PET
intravenous injection of 100 to 120 MBq of FDG
MRI
Magnetic Resonance Imaging
Interventions
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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
[18F]AV-45 PET
intravenous injection of 4 MBq/kg of \[18F\]AV-45
18-FDG PET
intravenous injection of 100 to 120 MBq of FDG
MRI
Magnetic Resonance Imaging
Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
60 Years
ALL
Yes
Sponsors
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University Hospital, Tours
OTHER
Responsible Party
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Principal Investigators
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Vincent Camus
Role: PRINCIPAL_INVESTIGATOR
University Hospital of Tours
Locations
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university hospital of CAEN
Caen, , France
University Hospital of Lille
Lille, , France
University Hospital of Toulouse
Toulouse, , France
University Hospital of Tours
Tours, , France
Countries
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Other Identifiers
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PHRN08-VC / FAIR AD
Identifier Type: -
Identifier Source: org_study_id
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