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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684281
• Other study ID #: 2007-A00851-52
• Secondary ID: 2007-27
• Status: Completed
• Phase: N/A
• First received: May 21, 2008
• Last updated: August 27, 2014
• Start date: July 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2014
• Source: Assistance Publique Hopitaux De Marseille
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 90 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
France	Hopital de la Timone- Service de neurologie et de neuropsychologie	Marseille

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pursue the longitudinal study of a troop of subjects presenting an amnestic MCI in 36 months after the initial diagnosis		36 months	Yes
Primary	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	Yes
Primary	Identify the neuropsychological markers and of neuroimaging structural and metabolic useful in clinical practice which allow to predict an escalation		36 months	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	Establish diagnostic criteria which allow to improve the sensibility and the specificity of the premature diagnosis of MY.		36 months	Yes
Secondary	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	Yes
Secondary	Determine the specific character or not of the infringement of the memory of visual recognition in the novice Alzheimer's disease.		36 months	Yes
Secondary	Determine the specific character or not the atrophy and the metabolic modifications of regions under - hippocampiques in the novice Alzheimer's disease.		36 months	Yes
Secondary	Inform the existence of process of functional compensation in the population of aMCI, notably to those who show themselves stable or improve.		36 months	Yes