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Can the Assessment of the Subhippocampal Region Contribute to the Detection of Early Diagnosis of Alzheimer's Disease? A Validation Study Using PET With Florbetapir (AV-45).

Primary Purpose

Alzheimer's Disease

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET amyloid tracer (Florbetapir F18 AV45 F18
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

patients:

  • - A score in the MMS (Folstein and al ., on 1975, French version subjected to consensus of Greco). 24 for the level subjects I (less than 5 years of study), 26 and more for the others, the autonomy in the everyday life,
  • A lower normal IADL < = 1/4 (Lawton and Brody, on 1969, version 4 items),
  • A complaint mnemonic of the patient
  • A lower performance of 1,5 standard deviation in the standard in the reminder(abseiling) postponed from the sub-test of logical memory(report) of the WMS-III and/or in the free reminder(abseiling) postponed from the test(event) of the California Verbal Learning Test.

volunteers:

  • 50-80-year-old and presented an educational level sailed in that of the patients,
  • a MMS upper to 24 for the level subjects I (5 years of study), 26 and more for the levels 2 and 3,
  • an Autonomy of the everyday life,
  • normal IADL = 0/4
  • did not present mnemonic complaint,
  • a performance normal for the reminder postponed from the subtest of logical memory of the WMS-III and for the free reminder(abseiling) postponed from the test(event) of the California Verbal Learning Test.

Exclusion Criteria:

  • Incapacitated to realize the examination by FART because of medical intercurrent affections. There are this day no contraindications in the product Florbetapir used for the TEPscan.
  • The persons under protection of justice cannot be included, because the law forbids their participation biomedical researches.

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

patients

volunteers

Arm Description

Outcomes

Primary Outcome Measures

the assessment of subhippocampal dysfunction
PET amyloid tracer (Florbetapir F18 AV45 F18)

Secondary Outcome Measures

Full Information

First Posted
December 7, 2012
Last Updated
April 13, 2017
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01746706
Brief Title
Can the Assessment of the Subhippocampal Region Contribute to the Detection of Early Diagnosis of Alzheimer's Disease? A Validation Study Using PET With Florbetapir (AV-45).
Official Title
Can the Assessment of the Subhippocampal Region Contribute to the Detection of Early Diagnosis of Alzheimer's Disease?
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Reliable diagnosis of Alzheimer's Disease (AD) at the predementia stage is currently considered to be a priority for research, as disease modifying therapies are being evaluated. Many studies focus on the functional and morphological assessment of the hippocampal formation. However, neurofibrillary tangles, associated with cognitive deficits, initially affect the anterior subhippocampal cortex (transentorhinal, entorhinal and perirhinal cortex) before reaching the hippocampus. Studies from our group have tried to investigate if the assessment of subhippocampal regions using cognitive tools and neuroimaging techniques could contribute to the diagnosis of AD at a very early stage. In a previous project, the investigators included 40 patients with single domain amnestic MCI (Mild Cognitive Impairment), known to be at high risk for AD and demonstrated that aMCI patients with a profile of subhippocampal dysfunction (impaired performance on a visual recognition memory task) display other clinical as well as imaging profiles of patients with early AD using MRI and SPECT. Longitudinal follow-up data in these patients is currently under way. Preliminary data indicates that evaluating the subhippocampal region using visual recognition tasks is highly predictive of AD over 6 years. The aim of this project is to obtain additional diagnostic data using a PET amyloid tracer (Florbetapir F18 AV45 F18), an in-vivo marker of one of the neuropathological lesions that define AD, of in order to enhance diagnostic accuracy AD in these patients. This approach will validate the hypothesis as to whether the assessment of subhippocampal dysfunction can contribute to the early diagnosis of AD.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Title
volunteers
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
PET amyloid tracer (Florbetapir F18 AV45 F18
Primary Outcome Measure Information:
Title
the assessment of subhippocampal dysfunction
Description
PET amyloid tracer (Florbetapir F18 AV45 F18)
Time Frame
24month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: patients: - A score in the MMS (Folstein and al ., on 1975, French version subjected to consensus of Greco). 24 for the level subjects I (less than 5 years of study), 26 and more for the others, the autonomy in the everyday life, A lower normal IADL < = 1/4 (Lawton and Brody, on 1969, version 4 items), A complaint mnemonic of the patient A lower performance of 1,5 standard deviation in the standard in the reminder(abseiling) postponed from the sub-test of logical memory(report) of the WMS-III and/or in the free reminder(abseiling) postponed from the test(event) of the California Verbal Learning Test. volunteers: 50-80-year-old and presented an educational level sailed in that of the patients, a MMS upper to 24 for the level subjects I (5 years of study), 26 and more for the levels 2 and 3, an Autonomy of the everyday life, normal IADL = 0/4 did not present mnemonic complaint, a performance normal for the reminder postponed from the subtest of logical memory of the WMS-III and for the free reminder(abseiling) postponed from the test(event) of the California Verbal Learning Test. Exclusion Criteria: Incapacitated to realize the examination by FART because of medical intercurrent affections. There are this day no contraindications in the product Florbetapir used for the TEPscan. The persons under protection of justice cannot be included, because the law forbids their participation biomedical researches.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique Hopitaux De Marseille
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
mira DIDIC
Organizational Affiliation
AP HM
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France

12. IPD Sharing Statement

Learn more about this trial

Can the Assessment of the Subhippocampal Region Contribute to the Detection of Early Diagnosis of Alzheimer's Disease? A Validation Study Using PET With Florbetapir (AV-45).

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