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

Sponsor

University Hospital, Bordeaux (Other)

Overall Status

Unknown status

CT.gov ID

NCT02196116

Collaborator

Fondation Plan Alzheimer (Other), General Electric (Industry)

120

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Plaque, Amyloid Cognitive Deficits	Other: PET Other: MRI Other: neuropsychological tests	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Official Title:

Amyloïd Load in Elderly Population: Effect of Cognitive Reserve

Study Start Date :

Jul 1, 2014

Anticipated Primary Completion Date :

Jul 1, 2016

Anticipated Study Completion Date :

Jul 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: Group 1

Controls

Other: PET

PET Scan with [18F]-Flutemetamol

Other: MRI

Other: neuropsychological tests

Experimental: Group 2

Cognitively-impaired subjects without dementia and without memory

Other: PET

PET Scan with [18F]-Flutemetamol

Other: MRI

Other: neuropsychological tests

Experimental: Group 3

Cognitively-impaired subjects without dementia and with memory

Other: PET

PET Scan with [18F]-Flutemetamol

Other: MRI

Other: neuropsychological tests

Outcome Measures

Primary Outcome Measures

Amyloid load [at inclusion (day 0)]

Secondary Outcome Measures

Neuropsychological scores [At inclusion (Day 0)]
Educational level [At inclusion (Day 0)]
Memory complaint [At inclusion (Day 0)]

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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