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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
Sponsor:
Information provided by (Responsible Party):
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.

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

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U.S. FDA Resources

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



Primary Outcome Measures :
  1. 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 :
  1. 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
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:
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