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

Public Assistance-Hospitals of Marseille (AP-HM)

Status: Unknown

Conditions: Alzheimer's Disease

Treatments: Radiation: MRI; Procedure: PET; Biological: Apolipoprotein E genotyping; Biological: Clinic and neuropsychologic evaluation; Biological: Study of cerebrospinal fluid

Study type: Interventional

Funder types: Other

Identifiers

NCT00987090

2008-A01213-52

2008/24

Details and patient eligibility

About

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.

Enrollment: 240 estimated patients

Sex: All

Ages: 45 to 90 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 2 patient groups, including a placebo group

Alzheimer Disease

Active Comparator group

Description:

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

Treatment:

Radiation: MRI

Procedure: PET

Biological: Apolipoprotein E genotyping

Biological: Clinic and neuropsychologic evaluation

Biological: Study of cerebrospinal fluid

Control

Placebo Comparator group

Description:

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

Treatment:

Radiation: MRI

Procedure: PET

Biological: Apolipoprotein E genotyping

Biological: Clinic and neuropsychologic evaluation