System-IGF-1 Pathway and Alzheimer's Disease

NCT ID: NCT00647478

Last Updated: 2025-09-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

693 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2012-07-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

AD

No interventions assigned to this group

2

Control elderly subjects with normal cognitive function

No interventions assigned to this group

3

MCI

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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URC-CIC Paris Descartes Necker Cochin

OTHER

Sponsor Role collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier Hanon, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Assistance Publique - Hôpitaux de Paris

Locations

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Broca Hospital Memory Clinic (CMRR)

Paris, Paris, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 11314741 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25384548 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23015654 (View on PubMed)

Other Identifiers

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P060224

Identifier Type: -

Identifier Source: org_study_id

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