System-IGF-1 Pathway and Alzheimer's Disease (SIGAL)

Assistance Publique - Hôpitaux de Paris

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT00647478

P060224

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 693 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Caucasian patients after a comprehensive geriatric assessment and giving informed written consent.

- In each arm :

1. elderly subjects with normal cognitive function,
2. patients with dementia of AD type (DSM-IV and NINCDS-ADRDA criteria),
3. 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

Trial design

693 participants in 3 patient groups

1

Description:

AD

2

Description:

Control elderly subjects with normal cognitive function

3

Description:

MCI