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).

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01746706
First received: December 7, 2012
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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.


Condition Intervention
Alzheimer's Disease
Device: PET amyloid tracer (Florbetapir F18 AV45 F18

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Can the Assessment of the Subhippocampal Region Contribute to the Detection of Early Diagnosis of Alzheimer's Disease?

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • the assessment of subhippocampal dysfunction [ Time Frame: 24month ] [ Designated as safety issue: No ]
    PET amyloid tracer (Florbetapir F18 AV45 F18)


Estimated Enrollment: 80
Study Start Date: October 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: patients Device: PET amyloid tracer (Florbetapir F18 AV45 F18
Experimental: volunteers Device: PET amyloid tracer (Florbetapir F18 AV45 F18

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746706

Contacts
Contact: mira didic mira.didic@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: MIRA DIDIC       mira.didic@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique Hopitaux De Marseille
Principal Investigator: mira DIDIC AP HM
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01746706     History of Changes
Other Study ID Numbers: 2011 A00383-38
Study First Received: December 7, 2012
Last Updated: November 28, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 20, 2014