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

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ClinicalTrials.gov Identifier: NCT00684281
Recruitment Status : Completed
First Posted : May 26, 2008
Last Update Posted : August 28, 2014
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Other: Neurological and neuropsychological consultation, MRI Other: Neurological and neuropsychological consultation, MRI, Studies in imaging of drip, DNA Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : July 2008
Actual Primary Completion Date : April 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Pursue the longitudinal study of a troop of subjects presenting an amnestic MCI in 36 months after the initial diagnosis [ Time Frame: 36 months ]
  2. 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 ]
  3. Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict an escalation [ Time Frame: 36 months ]
  4. 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 ]
  5. 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 Measures :
  1. Establish diagnostic criteria which allow to improve the sensibility and the specificity of the premature diagnosis of MY. [ Time Frame: 36 months ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684281


Locations
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France
Hopital de la Timone- Service de neurologie et de neuropsychologie
Marseille, France, 13005
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Principal Investigator: Matthieu CECCALDI, MD Assistance Publique des Hopitaux de Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00684281    
Other Study ID Numbers: 2007-A00851-52
2007-27
First Posted: May 26, 2008    Key Record Dates
Last Update Posted: August 28, 2014
Last Verified: August 2014
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders