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

R

Regional University Hospital Center (CHRU)

Status and phase

Completed
Phase 2

Conditions

Alzheimer's Disease
Mild Cognitive Impairment

Treatments

Radiation: 18-FDG PET
Radiation: [18F]AV-45 PET
Other: MRI
Other: neuropsychologic assessment

Study type

Interventional

Funder types

Other

Identifiers

NCT01325259
PHRN08-VC / FAIR AD

Details and patient eligibility

About

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.

Enrollment

54 patients

Sex

All

Ages

60+ years old

Volunteers

Accepts Healthy Volunteers

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)

Trial design

Primary purpose

Diagnostic

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

54 participants in 3 patient groups

Alzheimer's disease
Experimental group
Description:
30 patients suffering from Alzheimer's disease
Treatment:
Other: MRI
Other: neuropsychologic assessment
Radiation: 18-FDG PET
Radiation: [18F]AV-45 PET
Mild Cognitive Impairment
Experimental group
Description:
20 patients suffering from Mild Cognitive Impairment
Treatment:
Other: MRI
Other: neuropsychologic assessment
Radiation: 18-FDG PET
Radiation: [18F]AV-45 PET
Control
Experimental group
Description:
15 subjects with no cognitive impairment
Treatment:
Other: MRI
Other: neuropsychologic assessment
Radiation: 18-FDG PET
Radiation: [18F]AV-45 PET

Trial contacts and locations

4

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Data sourced from clinicaltrials.gov

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