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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00987090
First received: September 29, 2009
Last updated: August 28, 2014
Last verified: August 2014
  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

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 240
Study Start Date: October 2009
Estimated Primary Completion Date: October 2015 (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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT00987090     History of Changes
Other Study ID Numbers: 2008/24, 2008-A01213-52
Study First Received: September 29, 2009
Last Updated: August 28, 2014
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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 27, 2014