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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT00647478
First received: March 26, 2008
Last updated: September 9, 2011
Last verified: August 2011
History of Changes
  Purpose

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

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Blood for plasma levels and polymorphisms in IGF1 system components


Estimated Enrollment: 747
Study Start Date: October 2007
Estimated Study Completion Date: December 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
AD
2
Control elderly subjects with normal cognitive function
3
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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Ambulatory Elderly subjects

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00647478

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

Publications:

Additional 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
Study First Received: March 26, 2008
Last Updated: September 9, 2011
Health Authority: France: Ministry of Health

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
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013