Early-onset and Late-onset Sporadic Alzheimer's Disease (AD)
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ClinicalTrials.gov Identifier: NCT00987090 |
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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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 |

Arm | Intervention/treatment |
---|---|
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
|
- to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting. [ Time Frame: 3 years ]
- 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, Senior) |
Sexes Eligible for Study: | All |
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

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
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 |
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:
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 Neurocognitive Disorders Mental Disorders |