Early-onset and Late-onset Sporadic Alzheimer's Disease (AD)
Recruitment status was Recruiting
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Alzheimer's Disease |
Biological: Clinic and neuropsychologic evaluation Radiation: MRI Procedure: PET Biological: Apolipoprotein E genotyping Biological: Study of cerebrospinal fluid |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
- to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 240 |
| Study Start Date: | October 2009 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Alzheimer Disease
subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old
|
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
|
|
Placebo Comparator: Control
subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old.
|
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
|
Eligibility| Ages Eligible for Study: | 45 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Contact: Mathieu Ceccaldi | mathieu.ceccaldi@ap-hm.fr |
| France | |
| Assistance Publique - Hôpitaux de Marseille | Recruiting |
| Marseille, France | |
| Contact: Mathieu Ceccaldi mathieu.ceccaldi@ap-hm.fr | |
| Principal Investigator: Mathieu Ceccaldi | |
| Principal Investigator: | mathieu ceccaldi | Assistance Publique - Hôpitaux de Marseille |
More Information
No publications provided
| Responsible Party: | Assistance Publique Hopitaux De Marseille, Direction de la recherche |
| ClinicalTrials.gov Identifier: | NCT00987090 History of Changes |
| Other Study ID Numbers: | 2008/24, 2008-A01213-52 |
| Study First Received: | September 29, 2009 |
| Last Updated: | May 18, 2010 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by Assistance Publique Hopitaux De Marseille:
|
subjects developing symptoms of Alzheimer Disease |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013