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

Not Applicable

• Conditions: Alzheimer's Disease
• Interventions: Biological: Clinic and neuropsychologic evaluation; Radiation: MRI; Procedure: PET; Biological: Apolipoprotein E genotyping; Biological: Study of cerebrospinal fluid

• Registration Number: NCT00987090
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Study Start: 2009-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-22
• Last Update Posted: 2015-10-23
• Primary Completion: 2016-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 240

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Alzheimer Disease	MRI	subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old
Alzheimer Disease	Study of cerebrospinal fluid	subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old
Alzheimer Disease	Clinic and neuropsychologic evaluation	subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old
Alzheimer Disease	Apolipoprotein E genotyping	subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old
Control	Clinic and neuropsychologic evaluation	subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old.
Control	Apolipoprotein E genotyping	subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old.
Alzheimer Disease	PET	subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old
Control	MRI	subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old.
Control	PET	subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Assistance Publique - Hôpitaux de Marseille; 🇫🇷 Marseille, France