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

Brief Summary

Official Title: “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”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic
  • Study Primary Completion Date: October 2015

Interventions Used in this Clinical Trial

  • Biological: Clinic and neuropsychologic evaluation
    • evaluation at the inclusion and 18 months after
  • Radiation: MRI
    • intervention at the inclusion and 18 months after
  • Procedure: PET
    • 18-FDG (18-fluoro-2-deoxyglucose)PET imaging of the brain at the inclusion and 18 months after.
  • Biological: Apolipoprotein E genotyping
    • genotyping at the inclusion
  • Biological: Study of cerebrospinal fluid
    • intervention at the inclusion

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: Alzheimer Disease
    • subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old
  • Placebo Comparator: Control
    • subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old.

Outcome Measures for this Clinical Trial

Primary Measures

  • to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting.
    • Time Frame: 3 years
      Safety Issue?: No

Secondary Measures

  • 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.
    • Time Frame: 3 years
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 45 Years

Maximum Age for this Clinical Trial: 90 Years

Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers

Clinical Trial Investigator Information

  • Lead Sponsor
    • Assistance Publique Hopitaux De Marseille
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • mathieu ceccaldi, Principal Investigator, Assistance Publique – Hôpitaux de Marseille
  • Overall Contact(s)
    • Mathieu Ceccaldi, mathieu.ceccaldi@ap-hm.fr

Source

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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00987090