FluoroAv45 Imaging Research-in Alzheimer's Disease

Study Overview
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Brief Summary
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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.

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

Conditions
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Alzheimer's Disease, Mild Cognitive Impairment

Intervention / Treatment
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* Other: neuropsychologic assessment
* Radiation: [18F]AV-45 PET
* Radiation: 18-FDG PET
* Other: MRI


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | inclusion |