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Completed

NCT Number: NCT00647478

System-IGF-1 Pathway and Alzheimer's Disease

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).

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Function 1, Social Control With Normal Activities of Daily Living Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Broca Hospital Memory Clinic (CMRR)

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • URC-CIC Paris Descartes Necker Cochin

Registry information

Official study 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.

Acronym: SIGAL

Important dates

Study start
2007
Primary completion
2010
Study completion
2012
First posted
Mar 31, 2008
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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