Early-onset and Late-onset Sporadic Alzheimer's Disease (AD)
October 22, 2015 updated by: Assistance Publique Hopitaux De Marseille
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
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.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
240
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Marseille, France
- Recruiting
- assistance publique - hôpitaux de Marseille
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 90 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Alzheimer Disease
subjects who have developed symptoms of Alzheimer Disease aged from 45 to 85 years old
|
evaluation at the inclusion and 18 months after
intervention 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.
genotyping at the inclusion
intervention at the inclusion
|
|
PLACEBO_COMPARATOR: Control
subjects without symptoms of Alzheimer Disease aged from 45 to 85 years old.
|
evaluation at the inclusion and 18 months after
intervention 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.
genotyping at the inclusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
to establish the impact of age on the clinical and neuroimaging picture of sporadic Alzheimer Disease in a multicentric setting.
Time Frame: 3 years
|
3 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
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
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: mathieu ceccaldi, assistance publique - hôpitaux de Marseille
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (ANTICIPATED)
September 1, 2016
Study Registration Dates
First Submitted
September 29, 2009
First Submitted That Met QC Criteria
September 29, 2009
First Posted (ESTIMATE)
September 30, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
October 23, 2015
Last Update Submitted That Met QC Criteria
October 22, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008/24
- 2008-A01213-52
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.