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CompletedNCT00647478SIGALUpdated Mar 11, 2026

System-IGF-1 Pathway and Alzheimer's Disease

An observational study in Alzheimer's Disease, Mild Cognitive Impairment and Cognitive Function 1, Social, sponsored by Assistance Publique - Hôpitaux de Paris. Completed at 1 site in France. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-03-11.

Sponsored by Assistance Publique - Hôpitaux de Paris · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
693
Ages
65 Years and older
Sex
All
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Study 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).

Read the 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.

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Conditions studied

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

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
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's enrollment of 693 is above the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Ambulatory Elderly subjects

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

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

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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
693 participants (actual)
Biospecimen retention
Samples with dna

Groups and cohorts

  • 1

    AD

  • 2

    Control elderly subjects with normal cognitive function

  • 3

    MCI

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What researchers measure

Primary outcomes

  1. Circulating IGF-I and IGFBP-3 levels in AD patients and control elderly subjects at the time of assessment(T0).

    Time frame: 24 hours

Secondary outcomes

  1. Circulating IGF-I and IGFBP-3 levels

    Time frame: 24 hours

  2. Genetic polymorphisms in IGF-I / IGFBP-3

    Time frame: 24 hours

  3. Circulating IGF-I and IGFBP-3 levels and genetic polymorphisms in IGF-I / IGFBP-3 according to cognitive function.

    Time frame: 24 hours

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Study locations

1 site
  • Broca Hospital Memory Clinic (CMRR)
    Paris, Paris 75013, France
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References and documents

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. PubMed 11314741 ↗
  • 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. PubMed 25384548 ↗
  • 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. PubMed 23015654 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00647478
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
URC-CIC Paris Descartes Necker Cochin
Responsible party
Sponsor
First posted
Mar 31, 2008
Start date
Oct 2007
Primary completion
Oct 2010
Completion
Jul 2012
Last update
Mar 11, 2026

Study contacts

Olivier Hanon, MD, PhD
principal investigator · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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