search
Back to results

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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neurological and neuropsychological consultation, MRI
Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hopital de la Timone- Service de neurologie et de neuropsychologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

1

2

Arm Description

Subject control

40 patients before hand include in a program

Outcomes

Primary Outcome Measures

Pursue the longitudinal study of a troop of subjects presenting an amnestic MCI in 36 months after the initial diagnosis
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.
Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict an escalation
Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict a stabilization or an improvement.
Improve the state of the knowledge on the origin of the confusions mnésiques isolated at the persons of fifty and more years old.

Secondary Outcome Measures

Establish diagnostic criteria which allow to improve the sensibility and the specificity of the premature diagnosis of MY.
Determine if the ultra-premature diagnosis of MY at a stage where the hurts are still confined in the structures under - hippocampiques is possible.
Determine the specific character or not of the infringement of the memory of visual recognition in the novice Alzheimer's disease.
Determine the specific character or not the atrophy and the metabolic modifications of regions under - hippocampiques in the novice Alzheimer's disease.
Inform the existence of process of functional compensation in the population of aMCI, notably to those who show themselves stable or improve.

Full Information

First Posted
May 21, 2008
Last Updated
August 27, 2014
Sponsor
Assistance Publique Hopitaux De Marseille
search

1. Study Identification

Unique Protocol Identification Number
NCT00684281
Brief Title
Early Diagnosis of Alzheimer's Disease: Clinical, Neuropsychological and Neuroimaging Follow-up of a Cohort of Patients With an Isolated Memory Impairment
Official Title
Early Diagnosis of Alzheimer's Disease: Clinical, Neuropsychological and Neuroimaging Follow-up of a Cohort of Patients With an Isolated Memory Impairment
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
Subject control
Arm Title
2
Arm Type
Experimental
Arm Description
40 patients before hand include in a program
Intervention Type
Other
Intervention Name(s)
Neurological and neuropsychological consultation, MRI
Intervention Description
Neurological and neuropsychological consultation, MRI for the month 0, 18 and 36
Intervention Type
Other
Intervention Name(s)
Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA
Intervention Description
Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA, months 0/18/36
Primary Outcome Measure Information:
Title
Pursue the longitudinal study of a troop of subjects presenting an amnestic MCI in 36 months after the initial diagnosis
Time Frame
36 months
Title
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
Title
Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict an escalation
Time Frame
36 months
Title
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
Title
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
Secondary Outcome Measure Information:
Title
Establish diagnostic criteria which allow to improve the sensibility and the specificity of the premature diagnosis of MY.
Time Frame
36 months
Title
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
Title
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
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthieu CECCALDI, MD
Organizational Affiliation
Assistance Publique des Hopitaux de Marseille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hopital de la Timone- Service de neurologie et de neuropsychologie
City
Marseille
ZIP/Postal Code
13005
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs