Early-onset and Late-onset Sporadic Alzheimer's Disease (AD)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-10-31

Brief Summary

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Alzheimer's disease (AD) is usually associated with aging, age being the principal identified risk factor. However, younger subjects also develop AD and the prevalence of early onset AD is unknown. It is estimated that about 30 000 subjects develop symptoms of AD before the age of 65 in France. There is evidence that early onset AD differs from AD in older patients. In particular, clinical and neuroimaging studies suggest early involvement of neocortical brain regions and their functions in early onset AD, while mediotemporal areas and memory might be more involved in late onset AD. These differences could partly explain the atypical clinical and imaging features of younger patients, the diagnostic difficulties in these patients and the specific problems related to medical care of this age group. The present study uses a multidisciplinary approach with longitudinal followup in order to establish the impact of age on the clinical and neuroimaging picture of sporadic AD in a multicentric setting. Another aim of the project is to describe for each age group, and in particular for the younger patient group, the functional impact of disability in everyday life on both, patients and caregivers.

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Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Alzheimer Disease

subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old

Group Type ACTIVE_COMPARATOR

Clinic and neuropsychologic evaluation

Intervention Type BIOLOGICAL

evaluation at the inclusion and 18 months after

MRI

Intervention Type RADIATION

intervention at the inclusion and 18 months after

PET

Intervention Type PROCEDURE

18-FDG (18-fluoro-2-deoxyglucose)PET imaging of the brain at the inclusion and 18 months after.

Apolipoprotein E genotyping

Intervention Type BIOLOGICAL

genotyping at the inclusion

Study of cerebrospinal fluid

Intervention Type BIOLOGICAL

intervention at the inclusion

Control

subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old.

Group Type PLACEBO_COMPARATOR

Clinic and neuropsychologic evaluation

Intervention Type BIOLOGICAL

evaluation at the inclusion and 18 months after

MRI

Intervention Type RADIATION

intervention at the inclusion and 18 months after

PET

Intervention Type PROCEDURE

18-FDG (18-fluoro-2-deoxyglucose)PET imaging of the brain at the inclusion and 18 months after.

Apolipoprotein E genotyping

Intervention Type BIOLOGICAL

genotyping at the inclusion

Interventions

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Clinic and neuropsychologic evaluation

evaluation at the inclusion and 18 months after

Intervention Type BIOLOGICAL

MRI

intervention at the inclusion and 18 months after

Intervention Type RADIATION

PET

18-FDG (18-fluoro-2-deoxyglucose)PET imaging of the brain at the inclusion and 18 months after.

Intervention Type PROCEDURE

Apolipoprotein E genotyping

genotyping at the inclusion

Intervention Type BIOLOGICAL

Study of cerebrospinal fluid

intervention at the inclusion

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Arm Alzheimer Disease : first symptoms from 1 to 5 years before the inclusion, Clinical Dementia Rating = 1, efficient contraception for women
* Arm Control : efficient contraception for women

Exclusion Criteria

* Important general disease : diabetes, neoplasia, alcoholism
* First symptoms less than 1 year or more than 5 years before the inclusion
* Pregnancy, breast feeding

Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes