Early Diagnosis of Alzheimer's Disease: Clinical, Neuropsychological and Neuroimaging Follow-up of a Cohort of Patients With an Isolated Memory Impairment

August 27, 2014 updated by: Assistance Publique Hopitaux De Marseille
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The syndrome of "amnestic Mild Cognitive Impairment" (aMCI) has been introduced for patients with intact activities of daily living, with a memory complaint and objective memory decline on neuropathological assessment, without significative change in other domains of cognition. Follow-up in these patients shows that the memory impairment may remain stable or improve, while it worsens or extends to other cognitive domains in others, indicating prodromal AD.

Study Type

Interventional

Enrollment (Actual)

60

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
      • Marseille, France, 13005
        • Hopital de la Timone- Service de neurologie et de neuropsychologie

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

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients beforehand include in the PHRC 2001 study (These patients presented to the inclusion in the PHRC 2001 a qualified board of amnestic Mild Cognitive Impairment [aMCI] or light cognitive confusion of type amnestic)
  • The patient must be affiliated to an insurance scheme disease to participate in this study

Exclusion Criteria:

  • 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

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

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 1
Subject control
Other: Neurological and neuropsychological consultation, MRI
Neurological and neuropsychological consultation, MRI for the month 0, 18 and 36
Experimental: 2
40 patients before hand include in a program
Other: Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA
Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA, months 0/18/36

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pursue the longitudinal study of a troop of subjects presenting an amnestic MCI in 36 months after the initial diagnosis
Time Frame: 36 months
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.
Time Frame: 36 months
36 months
Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict an escalation
Time Frame: 36 months
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.
Time Frame: 36 months
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.
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Establish diagnostic criteria which allow to improve the sensibility and the specificity of the premature diagnosis of MY.
Time Frame: 36 months
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.
Time Frame: 36 months
36 months
Determine the specific character or not of the infringement of the memory of visual recognition in the novice Alzheimer's disease.
Time Frame: 36 months
36 months
Determine the specific character or not the atrophy and the metabolic modifications of regions under - hippocampiques in the novice Alzheimer's disease.
Time Frame: 36 months
36 months
Inform the existence of process of functional compensation in the population of aMCI, notably to those who show themselves stable or improve.
Time Frame: 36 months
36 months

Collaborators and Investigators

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

Sponsor

Assistance Publique Hopitaux De Marseille

Investigators

  • Principal Investigator: Matthieu CECCALDI, MD, Assistance Publique des Hôpitaux de Marseille

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, 2008

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

May 21, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 26, 2008

Study Record Updates

Last Update Posted (Estimate)

August 28, 2014

Last Update Submitted That Met QC Criteria

August 27, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007-A00851-52
  • 2007-27

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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