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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00987090
• Other study ID #: 2008/24
• Secondary ID: 2008-A01213-52
• Status: Recruiting
• Phase: N/A
• First received: September 29, 2009
• Last updated: October 22, 2015
• Start date: October 2009

Study information

• Verified date: October 2015
• Source: Assistance Publique Hopitaux De Marseille
• Contact: Mathieu Ceccaldi
• Email: mathieu.ceccaldi[@]ap-hm.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 45 Years to 90 Years

Eligibility

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

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

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
• Study of cerebrospinal fluid
intervention at the inclusion

Locations

Country	Name	City	State
France	Assistance Publique - Hôpitaux de Marseille	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	to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting.		3 years	No
Secondary	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	No