FluoroAv45 Imaging Research-in Alzheimer's Disease

Mild Cognitive Impairment Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325259
• Other study ID #: PHRN08-VC / FAIR AD
• Status: Completed
• Phase: Phase 2
• First received: February 21, 2011
• Last updated: February 5, 2016
• Start date: April 2009
• Est. completion date: December 2013

Study information

• Verified date: February 2016
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2013
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years and older

Eligibility

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)

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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
• 18-FDG PET
intravenous injection of 100 to 120 MBq of FDG

Other:
• MRI
Magnetic Resonance Imaging

Locations

Country	Name	City	State
France	university hospital of CAEN	Caen
France	University Hospital of Lille	Lille
France	University Hospital of Toulouse	Toulouse
France	University Hospital of Tours	Tours

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No