NCT00647478

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
693

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2008

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 31, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

3 years

First QC Date

March 26, 2008

Last Update Submit

March 9, 2026

Conditions

Mild Cognitive ImpairmentCognitive Function 1, SocialAlzheimer's DiseaseControl With Normal Activities of Daily Living

Keywords

Insulin-like Growth FactorInsulin-like Growth Factor binding protein 3Insulin-like Growth Factor-I system component levelsInsulin-like Growth Factor-I polymorphismAlzheimer's diseaseMild Cognitive ImpairmentNormal cognitive functionObservational cross sectional study

Outcome Measures

Primary Outcomes (1)

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

    24 hours

Secondary Outcomes (3)

  • 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

Study Arms (3)

1

AD

2

Control elderly subjects with normal cognitive function

3

MCI

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ambulatory Elderly subjects

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Broca Hospital Memory Clinic (CMRR)

Paris, Paris, 75013, France

Location

Related Publications (3)

  • 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.

    PMID: 11314741BACKGROUND

  • 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.

    PMID: 25384548RESULT

  • 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.

    PMID: 23015654RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood for plasma levels and polymorphisms in IGF1 system components

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Olivier Hanon, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2008

First Posted

March 31, 2008

Study Start

October 1, 2007

Primary Completion

October 1, 2010

Study Completion

July 1, 2012

Last Updated

March 11, 2026

Record last verified: 2026-03

Locations

FR(1)