System-IGF-1 Pathway and Alzheimer's Disease

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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.

Conditions
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Alzheimer's Disease, Mild Cognitive Impairment, Cognitive Function 1, Social, Control With Normal Activities of Daily Living

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Caucasian patients after a comprehensive geriatric assessment and giving informed written consent. - In each arm : elderly subjects with normal cognitive function, patients with dementia of AD type (DSM-IV and NINCDS-ADRDA criteria), patients with MCI (European Consortium on Alzheimer's Disease, EADC). Exclusion Criteria: Non AD dementia Major depression Use of anticholinesterase agent All diseases or major sensory deficits or any condition that might interfere with cognitive assessment and study objectives

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>AD | |
| 2<br>Control elderly subjects with normal cognitive function | |
| 3<br>MCI | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating IGF-I and IGFBP-3 levels in AD patients and control elderly subjects at the time of assessment(T0). |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating IGF-I and IGFBP-3 levels |  | 24 hours | 
| Genetic polymorphisms in IGF-I / IGFBP-3 |  | 24 hours | 
| Circulating IGF-I and IGFBP-3 levels and genetic polymorphisms in IGF-I / IGFBP-3 according to cognitive function. |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Insulin-like Growth Factor, Insulin-like Growth Factor binding protein 3, Insulin-like Growth Factor-I system component levels, Insulin-like Growth Factor-I polymorphism, Alzheimer's disease, Mild Cognitive Impairment, Normal cognitive function, Observational cross sectional study