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

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.

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).

Study Overview

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

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.

• Study Type: Observational
• Enrollment (Actual): 693

Contacts and Locations

Study Locations

• France
  • Paris
    • Paris, Paris, France, 75013
      • Broca Hospital Memory Clinic (CMRR)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Ambulatory Elderly subjects

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
1; AD
2; Control elderly subjects with normal cognitive function
3; MCI

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: URC-CIC Paris Descartes Necker Cochin
• Investigators: Principal Investigator: Olivier Hanon, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

General Publications

• Murialdo G, Barreca A, Nobili F, Rollero A, Timossi G, Gianelli MV, Copello F, Rodriguez G, Polleri A. Relationships between cortisol, dehydroepiandrosterone sulphate and insulin-like growth factor-I system in dementia. J Endocrinol Invest. 2001 Mar;24(3):139-46. doi: 10.1007/BF03343833.
• Duron E, Vidal JS, Funalot B, Brunel N, Viollet C, Rigaud AS, Labouree F, Epelbaum J, le Bouc Y, Hanon O. Insulin-Like Growth Factor-I, Insulin-Like Growth factor Binding Protein-3 and Blood Hemoglobin Concentration in an Elderly Population. J Gerontol A Biol Sci Med Sci. 2015 Jul;70(7):854-9. doi: 10.1093/gerona/glu200. Epub 2014 Nov 9.
• Duron E, Funalot B, Brunel N, Coste J, Quinquis L, Viollet C, Belmin J, Jouanny P, Pasquier F, Treluyer JM, Epelbaum J, le Bouc Y, Hanon O. Insulin-like growth factor-I and insulin-like growth factor binding protein-3 in Alzheimer's disease. J Clin Endocrinol Metab. 2012 Dec;97(12):4673-81. doi: 10.1210/jc.2012-2063. Epub 2012 Sep 26.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2007
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): July 1, 2012

Study Registration Dates

• First Submitted: March 26, 2008
• First Submitted That Met QC Criteria: March 28, 2008
• First Posted (Estimated): March 31, 2008

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 9, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Alzheimer's disease; Mild Cognitive Impairment; Normal cognitive function; 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; Observational cross sectional study
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease
• Other Study ID Numbers: P060224