NCT00684281

Brief Summary

The aim of this project is to follow cohort of patients with aMCI in order to establish whether there are distinct subgroups in terms of evolution or aetiology, with distinct memory profiles and profiles of mesiotemporal atrophy and metabolic change

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2008

Longer than P75 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

May 21, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 26, 2008

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2008

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 28, 2014

Status Verified

August 1, 2014

Enrollment Period

2.8 years

First QC Date

May 21, 2008

Last Update Submit

August 27, 2014

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (5)

  • Pursue the longitudinal study of a troop of subjects presenting an amnestic MCI in 36 months after the initial diagnosis

    36 months

  • Characterize the clinical evolution of these subjects: escalation with appearance of an insanity (of type Alzheimer's disease or of another type: degenerations fronto-temporal, insanity with body of Lewy), stabilization even improvement.

    36 months

  • Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict an escalation

    36 months

  • Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict a stabilization or an improvement.

    36 months

  • Improve the state of the knowledge on the origin of the confusions mnésiques isolated at the persons of fifty and more years old.

    36 months

Secondary Outcomes (5)

  • Establish diagnostic criteria which allow to improve the sensibility and the specificity of the premature diagnosis of MY.

    36 months

  • Determine if the ultra-premature diagnosis of MY at a stage where the hurts are still confined in the structures under - hippocampiques is possible.

    36 months

  • Determine the specific character or not of the infringement of the memory of visual recognition in the novice Alzheimer's disease.

    36 months

  • Determine the specific character or not the atrophy and the metabolic modifications of regions under - hippocampiques in the novice Alzheimer's disease.

    36 months

  • Inform the existence of process of functional compensation in the population of aMCI, notably to those who show themselves stable or improve.

    36 months

Study Arms (2)

1

OTHER

Subject control

Other: Neurological and neuropsychological consultation, MRI

2

EXPERIMENTAL

40 patients before hand include in a program

Other: Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA

Interventions

Neurological and neuropsychological consultation, MRIOTHER

Neurological and neuropsychological consultation, MRI for the month 0, 18 and 36

1
Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNAOTHER

Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA, months 0/18/36

2

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient must be affiliated to an insurance scheme disease to participate in this study

You may not qualify if:

  • For the magnetic resonance imaging: usual contraindications for an examination by MRI: claustrophobia, metal foreign bodies, pacemakers, etc.
  • Incapacitated to realize the neuropsychological evaluation because of medical intercurrentes disorders
  • Appointment of a guardian

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital de la Timone- Service de neurologie et de neuropsychologie

Marseille, 13005, France

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Magnetic Resonance SpectroscopyDNA

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesNucleic AcidsNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Matthieu CECCALDI, MD

    Assistance Publique des Hopitaux de Marseille

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 21, 2008

First Posted

May 26, 2008

Study Start

July 1, 2008

Primary Completion

April 1, 2011

Study Completion

December 1, 2011

Last Updated

August 28, 2014

Record last verified: 2014-08

Locations

FR(1)