FluoroAv45 Imaging Research-in Alzheimer's Disease

NCT01325259 | Completed Phase 2 DMC

• 1 other identifier: PHRN08-VC / FAIR AD
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Alzheimer's Disease; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Alzheimer's disease

EXPERIMENTAL

30 patients suffering from Alzheimer's disease

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

Mild Cognitive Impairment

EXPERIMENTAL

20 patients suffering from Mild Cognitive Impairment

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

Control

EXPERIMENTAL

15 subjects with no cognitive impairment

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

Interventions

neuropsychologic assessment OTHER

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

Alzheimer's disease; Control; Mild Cognitive Impairment

[18F]AV-45 PET RADIATION

intravenous injection of 4 MBq/kg of \[18F\]AV-45

Alzheimer's disease; Control; Mild Cognitive Impairment

18-FDG PET RADIATION

intravenous injection of 100 to 120 MBq of FDG

Alzheimer's disease; Control; Mild Cognitive Impairment

MRI OTHER

Magnetic Resonance Imaging

Alzheimer's disease; Control; Mild Cognitive Impairment

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients suffering from Alzheimer's Disease (NINCDS-ADRDA) or from amnesic MCI
• \< MMS \<= 28 for patients
• \<= MMS for healthy volunteers
• study period \> 7 years
• native language : french
• signed informed consent
• affiliated to a social security system

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (4)

university hospital of CAEN

Caen, 14000, France

Location

University Hospital of Lille

Lille, 59000, France

Location

University Hospital of Toulouse

Toulouse, 31000, France

Location

University Hospital of Tours

Tours, 37000, France

Location

MeSH Terms

Conditions

Alzheimer Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Vincent Camus

  University Hospital of Tours

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2011
• First Posted: March 29, 2011
• Study Start: April 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2013
• Last Updated: February 8, 2016

Record last verified: 2016-02

Locations

FR (4)