System-IGF-1 Pathway and Alzheimer's Disease

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00647478

Acronym

SIGAL

Enrollment

693

Registered

2008-03-31

Start date

2007-10-01

Completion date

2012-07-01

Last updated

2026-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

Brief summary

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

France

Contacts

PRINCIPAL_INVESTIGATOROlivier Hanon, MD, PhD

Assistance Publique - Hôpitaux de Paris

Outcome results