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

Study Overview
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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.

Official Title
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Early-onset and Late-onset Sporadic Alzheimer's Disease (AD) : Variations of the Clinical Profile and Paraclinical Features Depending on the Age at the Onset of Clinical Signs

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Biological: Clinic and neuropsychologic evaluation
* Radiation: MRI
* Procedure: PET
* Biological: Apolipoprotein E genotyping
* Biological: Study of cerebrospinal fluid


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Alzheimer Disease<br>subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old | Biological: Clinic and neuropsychologic evaluation<br>* evaluation at the inclusion and 18 months after<br>Radiation: MRI<br>* intervention at the inclusion and 18 months after<br>Procedure: PET<br>* 18-FDG (18-fluoro-2-deoxyglucose)PET imaging of the brain at the inclusion and 18 months after.<br>Biological: Apolipoprotein E genotyping<br>* genotyping at the inclusion<br>Biological: Study of cerebrospinal fluid<br>* intervention at the inclusion<br>|
| Placebo Comparator: Control<br>subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old. | Biological: Clinic and neuropsychologic evaluation<br>* evaluation at the inclusion and 18 months after<br>Radiation: MRI<br>* intervention at the inclusion and 18 months after<br>Procedure: PET<br>* 18-FDG (18-fluoro-2-deoxyglucose)PET imaging of the brain at the inclusion and 18 months after.<br>Biological: Apolipoprotein E genotyping<br>* genotyping at the inclusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting. |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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subjects developing symptoms of Alzheimer Disease