System-IGF-1 Pathway and Alzheimer's Disease | NCT00647478

Studies
System-IGF-1 Pathway and Alzheimer's Disease

NCT00647478

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Completed

Last Update Posted

Mar 11, 2026Actual

Enrollment

693Actual

Phase

Not provided

Conditions

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

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2007Actual

Primary Completion Date

Oct 2010Actual

Completion Date

Jul 2012Actual

First Submitted Date

Mar 26, 2008

First Submission Date that Met QC Criteria

Mar 28, 2008

First Posted Date

Mar 31, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 9, 2026

Last Update Posted Date

Mar 11, 2026Actual

Name	Class
URC-CIC Paris Descartes Necker Cochin	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Conditions Module

Conditions

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

693Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		AD
2		Control elderly subjects with normal cognitive function
3		MCI

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	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 Outcomes

Measure	Description	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.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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).

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

Ambulatory Elderly subjects

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Olivier Hanon, MD, PhD	Assistance Publique - Hôpitaux de Paris	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Broca Hospital Memory Clinic (CMRR)		Paris	Paris	75013	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11314741	Background	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.
25384548	Result

ID	Term
D000544	Alzheimer Disease
D060825	Cognitive Dysfunction

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases