Early-onset and Late-onset Sporadic Alzheimer's Disease (AD)
2 other identifiers
interventional
240
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2009
CompletedFirst Posted
Study publicly available on registry
September 30, 2009
CompletedStudy Start
First participant enrolled
October 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2016
CompletedOctober 23, 2015
October 1, 2015
6.9 years
September 29, 2009
October 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting.
3 years
Secondary Outcomes (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.
3 years
Study Arms (2)
Alzheimer Disease
ACTIVE COMPARATORsubjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old
Control
PLACEBO COMPARATORsubjects without symptoms of Alzheimer Disease aged from 45 to 85 years old.
Interventions
evaluation at the inclusion and 18 months after
18-FDG (18-fluoro-2-deoxyglucose)PET imaging of the brain at the inclusion and 18 months after.
Eligibility Criteria
You may qualify if:
- Arm Control : efficient contraception for women
You may not qualify if:
- Important general disease : diabetes, neoplasia, alcoholism
- Pregnancy, breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assistance Publique - Hôpitaux de Marseille
Marseille, France, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
mathieu ceccaldi
Assistance Publique - Hôpitaux de Marseille
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2009
First Posted
September 30, 2009
Study Start
October 1, 2009
Primary Completion
September 1, 2016
Last Updated
October 23, 2015
Record last verified: 2015-10