NCT01582919

Brief Summary

It is now acknowledged that Alzheimer's disease is characterized by a long period of pathophysiological change. Developing new strategies to achieve diagnoses as early as possible has become a major goal for therapies aimed at slowing the progression of this disease. While diagnoses currently rely principally on clinical neuropsychology, the typical diagnostic criteria of NINCDS-ADRDA are inapplicable in the early stage of the disease. The goal of our project is to identify very early imaging markers for Alzheimer's disease among patients with no report of cognitive difficulties. In order to achieve this goal, we propose a longitudinal study in an elderly population cohort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
304

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 20, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 23, 2012

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

April 4, 2017

Status Verified

March 1, 2017

Enrollment Period

2.7 years

First QC Date

April 20, 2012

Last Update Submit

March 31, 2017

Conditions

Keywords

dementiaAlzheimer's DiseasediagnosticbiomarkersneuroimagingPETMRImild cognitive impairment

Outcome Measures

Primary Outcomes (1)

  • Measures of volume and diffusion parameters in the gray matter (hippocampus and cingular posterior cortex)

    Inclusion (Day 0)

Secondary Outcomes (1)

  • Performance on neuropsychological and daily life cognitive tests

    Everyday up to Day 7 after inclusion

Study Arms (2)

Participant from AMI cohort

EXPERIMENTAL
Other: Neuroimaging

Participant from 3Ccohort

ACTIVE COMPARATOR
Other: Neuroimaging

Interventions

Participant from 3CcohortParticipant from AMI cohort

Eligibility Criteria

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

You may qualify if:

  • At least 65 years old
  • Be retired from agricultural profession
  • live in rural area in Gironde (France)

You may not qualify if:

  • Lefthanded
  • having a dementia (MMSE \< 13)
  • Having a vascular cerebral accident
  • Parkinson disease
  • Poor health condition does not allowing transport to neuroimaging service

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux

Bordeaux, 33000, France

Location

MeSH Terms

Conditions

DementiaAlzheimer DiseaseDiseaseCognitive Dysfunction

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCognition Disorders

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Michèle ALLARD, Pr

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 20, 2012

First Posted

April 23, 2012

Study Start

September 1, 2012

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

April 4, 2017

Record last verified: 2017-03

Locations