Early-onset and Late-onset Sporadic Alzheimer's Disease (AD)
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| ClinicalTrials.gov Identifier: NCT00987090 |
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Recruitment Status : Unknown
Verified October 2015 by Assistance Publique Hopitaux De Marseille.
Recruitment status was: Recruiting
First Posted : September 30, 2009
Last Update Posted : October 23, 2015
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Sponsor:
Assistance Publique Hopitaux De Marseille
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Biological: Clinic and neuropsychologic evaluation Radiation: MRI Procedure: PET Biological: Apolipoprotein E genotyping Biological: Study of cerebrospinal fluid | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 240 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (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 |
| Study Start Date : | October 2009 |
| Estimated Primary Completion Date : | September 2016 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Alzheimer Disease
subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old
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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 |
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Placebo Comparator: Control
subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old.
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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 |
Primary Outcome 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 ]
Secondary Outcome 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 ]
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| Ages Eligible for Study: | 45 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00987090
Contacts
| Contact: Mathieu Ceccaldi | mathieu.ceccaldi@ap-hm.fr |
Locations
| France | |
| Assistance Publique - Hôpitaux de Marseille | Recruiting |
| Marseille, France | |
| Contact: Mathieu Ceccaldi mathieu.ceccaldi@ap-hm.fr | |
| Principal Investigator: Mathieu Ceccaldi | |
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
| Principal Investigator: | mathieu ceccaldi | Assistance Publique - Hôpitaux de Marseille |
| Responsible Party: | Assistance Publique Hopitaux De Marseille |
| ClinicalTrials.gov Identifier: | NCT00987090 History of Changes |
| Other Study ID Numbers: |
2008/24 2008-A01213-52 |
| First Posted: | September 30, 2009 Key Record Dates |
| Last Update Posted: | October 23, 2015 |
| Last Verified: | October 2015 |
Keywords provided by Assistance Publique Hopitaux De Marseille:
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subjects developing symptoms of Alzheimer Disease |
Additional relevant MeSH terms:
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |