NCT02196116

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

February 12, 2015

Status Verified

February 1, 2015

Enrollment Period

2 years

First QC Date

July 17, 2014

Last Update Submit

February 11, 2015

Conditions

Plaque, AmyloidCognitive Deficits

Keywords

Alzheimer diseaseamyloid loadeducational levelcognitive performances

Outcome Measures

Primary Outcomes (1)

  • Amyloid load

    at inclusion (day 0)

Secondary Outcomes (3)

  • Neuropsychological scores

    At inclusion (Day 0)

  • Educational level

    At inclusion (Day 0)

  • Memory complaint

    At inclusion (Day 0)

Study Arms (3)

Group 1

ACTIVE COMPARATOR

Controls

Other: PETOther: MRIOther: neuropsychological tests

Group 2

EXPERIMENTAL

Cognitively-impaired subjects without dementia and without memory

Other: PETOther: MRIOther: neuropsychological tests

Group 3

EXPERIMENTAL

Cognitively-impaired subjects without dementia and with memory

Other: PETOther: MRIOther: neuropsychological tests

Interventions

PETOTHER

PET Scan with \[18F\]-Flutemetamol

Group 1Group 2Group 3
MRIOTHER
Group 1Group 2Group 3
neuropsychological testsOTHER
Group 1Group 2Group 3

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Bordeaux

Bordeaux, 33000, France

RECRUITING

MeSH Terms

Conditions

Plaque, AmyloidCognition DisordersAlzheimer Disease

Interventions

Neuropsychological Tests

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • Michèle ALLARD, MD-PhD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Michèle ALLARD, MD-PhD

CONTACT

Michele.allard@chu-bordeaux.fr

Caroline BUISSON, CRA

CONTACT

caroline.buisson@chu-bordeaux.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 21, 2014

Study Start

July 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

February 12, 2015

Record last verified: 2015-02

Locations

FR(1)