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

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ClinicalTrials.gov Identifier: NCT00647478
Recruitment Status : Completed
First Posted : March 31, 2008
Last Update Posted : June 6, 2013
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

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).

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

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.

Study Type : Observational
Actual Enrollment : 693 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Study Start Date : October 2007
Primary Completion Date : October 2010
Study Completion Date : July 2012

Control elderly subjects with normal cognitive function

Primary Outcome Measures :
  1. Circulating IGF-I and IGFBP-3 levels in AD patients and control elderly subjects at the time of assessment(T0). [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Circulating IGF-I and IGFBP-3 levels [ Time Frame: 24 hours ]
  2. Genetic polymorphisms in IGF-I / IGFBP-3 [ Time Frame: 24 hours ]
  3. Circulating IGF-I and IGFBP-3 levels and genetic polymorphisms in IGF-I / IGFBP-3 according to cognitive function. [ Time Frame: 24 hours ]

Biospecimen Retention:   Samples With DNA
Blood for plasma levels and polymorphisms in IGF1 system components

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Ambulatory Elderly subjects

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00647478

Broca Hospital Memory Clinic (CMRR)
Paris, France, 75013
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Principal Investigator: Olivier Hanon, MD, PhD Assistance Publique - Hôpitaux de Paris

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT00647478     History of Changes
Other Study ID Numbers: P060224
First Posted: March 31, 2008    Key Record Dates
Last Update Posted: June 6, 2013
Last Verified: June 2013

Keywords provided by Assistance Publique - Hôpitaux de Paris:
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

Additional relevant MeSH terms:
Alzheimer Disease
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders