System-IGF-1 Pathway and Alzheimer's Disease (SIGAL)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00647478
First received: March 26, 2008
Last updated: June 5, 2013
Last verified: June 2013

March 26, 2008
June 5, 2013
October 2007
October 2010   (final data collection date for primary outcome measure)
Circulating IGF-I and IGFBP-3 levels in AD patients and control elderly subjects at the time of assessment(T0). [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00647478 on ClinicalTrials.gov Archive Site
  • Circulating IGF-I and IGFBP-3 levels [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Genetic polymorphisms in IGF-I / IGFBP-3 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Circulating IGF-I and IGFBP-3 levels and genetic polymorphisms in IGF-I / IGFBP-3 according to cognitive function. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
System-IGF-1 Pathway and Alzheimer's Disease
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.

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).

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Blood for plasma levels and polymorphisms in IGF1 system components

Non-Probability Sample

Ambulatory Elderly subjects

  • Alzheimer's Disease
  • Mild Cognitive Impairment
  • Cognitive Function 1, Social
  • Control With Normal Activities of Daily Living.
Not Provided
  • 1
    AD
  • 2
    Control elderly subjects with normal cognitive function
  • 3
    MCI

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
693
July 2012
October 2010   (final data collection date for primary outcome measure)

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

Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
NCT00647478
P060224
No
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Olivier Hanon, MD, PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP