System-IGF-1 Pathway and Alzheimer's Disease

Mild Cognitive Impairment Clinical Trial

— SIGAL  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00647478
• Other study ID #: P060224
• Status: Completed
• Start date: October 2007
• Est. completion date: July 2012

Study information

• Verified date: June 2013
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 693
• Est. completion date: July 2012
• Est. primary completion date: October 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
France	Broca Hospital Memory Clinic (CMRR)	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (1)

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) — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Circulating IGF-I and IGFBP-3 levels in AD patients and control elderly subjects at the time of assessment(T0).		24 hours
Secondary	Circulating IGF-I and IGFBP-3 levels		24 hours
Secondary	Genetic polymorphisms in IGF-I / IGFBP-3		24 hours
Secondary	Circulating IGF-I and IGFBP-3 levels and genetic polymorphisms in IGF-I / IGFBP-3 according to cognitive function.		24 hours