Amyloïd Load in Elderly Population: Effect of Cognitive Reserve (EDUMA)

February 11, 2015 updated by: University Hospital, Bordeaux
This research aim to explore relationships between the presence of amyloid burden and cognitive performance, and its modulation by educational level. For this purpose we will combine Positron emission tomography (PET) imaging and neuropsychological assessment acquired on 3 groups of subjects, from two population-based cohorts "3C" and "AMIMage" The first group includes cognitively intact participants who will serve as controls, the second group, subjects with mild cognitive impairments without memory complaint and the third, subjects with both mild cognitive impairments and memory complaint.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Influence of educational level on the relationship between disease-specific lesion development and cognitive function will be assessed, as measured by amyloid PET imaging and a battery of neuropsychological tests at the very early stages of the disease, comparatively to age-matched controls. In addition, this project will explore the influence of cognitive complaint.

It's assumed that 1) the amyloid-PET measures in age-matched controls and subjects from the two cohorts will correlate with cognitive performances; 2) the amyloid burden will be higher in high- than in low-educated subjects with similar cognitive impairment; and 3) similarly the amyloid burden will be higher in subjects with cognitive complaint compared to subjects without cognitive complaint.

Considering a longer term, the clinical follow-up of study participants will allow to investigate the prognosis value of amyloid load for improving the prediction of cognitive decline and disease progression.

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33000
        • Recruiting
        • CHU de Bordeaux
        • Contact:
        • Principal Investigator:
          • Michèle ALLARD, MD, PhD
        • Sub-Investigator:
          • Jean-François DARTIGUES, Md, PhD
        • Sub-Investigator:
          • Philippe FERNANDEZ, MD, PhD
        • Sub-Investigator:
          • Jean-Simon ARNOULD, MD
        • Sub-Investigator:
          • Henri De CLERMONT GALLERANDE, MD
        • Sub-Investigator:
          • Paolo ZANOTTI FREGONARA, MD
        • Sub-Investigator:
          • Igor SIBON, MD,PhD
        • Sub-Investigator:
          • Alexandra FOUBERT, Md

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

Participation in the AMI or 3C cohorts Group 1- Controls

  • MMSE > 24 or > 26 for low and high levels of education, respectively.
  • Without memory impairment (for episodic memory) on the Free and Cued Selective Reminding Test RL/RI-16 items (FCSRT), free recall > 22 and total recall >42, according to the thresholds for population-based studies
  • Without memory complaint
  • Without dementia Group 2- Cognitively-impaired subjects without dementia and without memory complaints
  • Mini Mental State Evaluation (MMSE) < 24 or < 26 for low and high levels of education, respectively
  • With memory impairments according to the RL/RI-16 test (free recall≤22 and/or total recall ≤42), according to the thresholds for population-based studies defined by Auriacombe et al., 2010.
  • Without memory complaint
  • Without dementia Group 3- Cognitively-impaired subjects without dementia and with memory complaints
  • MMSE < 24 or < 26 for low and high levels of education, respectively
  • With memory impairments according to the RL/RI-16 test (same thresholds as above)
  • With memory complaint
  • Without dementia

Exclusion Criteria:

  • Being left handed
  • Presence of dementia (based on the clinical diagnosis)
  • Presence of stroke
  • Presence of Parkinson's disease
  • Presence of a counter-indication for MRI
  • Presence of a counter-indication for PET Scan with [18F]-Flutemetamol
  • Presence of any health problem preventing travel to the imaging service of the University Hospital
  • Being under the legal guardianship of another person or being unable to provide consent to participate
  • Pregnant or breastfeeding woman

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
Controls
Other: MRI
Other: PET
PET Scan with [18F]-Flutemetamol
Other: neuropsychological tests
Experimental: Group 2
Cognitively-impaired subjects without dementia and without memory
Other: MRI
Other: PET
PET Scan with [18F]-Flutemetamol
Other: neuropsychological tests
Experimental: Group 3
Cognitively-impaired subjects without dementia and with memory
Other: MRI
Other: PET
PET Scan with [18F]-Flutemetamol
Other: neuropsychological tests

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amyloid load
Time Frame: at inclusion (day 0)
at inclusion (day 0)

Secondary Outcome Measures

Outcome Measure
Time Frame
Neuropsychological scores
Time Frame: At inclusion (Day 0)
At inclusion (Day 0)
Educational level
Time Frame: At inclusion (Day 0)
At inclusion (Day 0)
Memory complaint
Time Frame: At inclusion (Day 0)
At inclusion (Day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

General Electric
Fondation Plan Alzheimer

Investigators

  • Principal Investigator: Michèle ALLARD, MD-PhD, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Anticipated)

July 1, 2016

Study Completion (Anticipated)

July 1, 2016

Study Registration Dates

First Submitted

July 17, 2014

First Submitted That Met QC Criteria

July 17, 2014

First Posted (Estimate)

July 21, 2014

Study Record Updates

Last Update Posted (Estimate)

February 12, 2015

Last Update Submitted That Met QC Criteria

February 11, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2013/02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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