System-IGF-1 Pathway and Alzheimer's Disease (SIGAL)
The aim is to assess the relationship between levels of IGF-I system components and cognitive status in patients with Alzheimer's disease (AD), in elderly subjects with normal cognitive function, and in patients with mild cognitive impairment (MCI).
Mild Cognitive Impairment
Cognitive Function 1, Social
Control With Normal Activities of Daily Living.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||A Multicenter Study to Assess Differences Between Circulating Levels of IGF-I and IGFBP-3 in Patients With Sporadic Late-onset Alzheimer's Disease and Control Elderly Subjects.|
- Circulating IGF-I and IGFBP-3 levels in AD patients and control elderly subjects at the time of assessment(T0). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Circulating IGF-I and IGFBP-3 levels [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Genetic polymorphisms in IGF-I / IGFBP-3 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
- Circulating IGF-I and IGFBP-3 levels and genetic polymorphisms in IGF-I / IGFBP-3 according to cognitive function. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Blood for plasma levels and polymorphisms in IGF1 system components
|Study Start Date:||October 2007|
|Study Completion Date:||July 2012|
|Primary Completion Date:||October 2010 (Final data collection date for primary outcome measure)|
Control elderly subjects with normal cognitive function
AD is the most common cause of dementia. During aging, decline of biological brain functions due to a number of genetic and environmental factors facilitates the onset of AD. MCI includes prodromal AD.
The identification of the risk factors for AD must be a priority in order to define the best therapeutic approach.
Recent data support the notion that IGF-I pathway accounts for neuronal protection, with a dual effect, on both brain Aβ peptide and tau protein.
This large, multicenter, prospective, observational, cross-sectional population-based study in 3 parallel groups (200 participants per group) is aimed to assess differences between IGF-I and IGFBP3 circulating levels and polymorphisms in AD patients and control elderly subjects, and in MCI patients.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647478
|Broca Hospital Memory Clinic (CMRR)|
|Paris, France, 75013|
|Principal Investigator:||Olivier Hanon, MD, PhD||Assistance Publique - Hôpitaux de Paris|