Clinical trial NCT00647478: System-IGF-1 Pathway and Alzheimer's Disease
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Cognitive Function 1, Social
Control With Normal Activities of Daily Living
Keywords: 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
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2008-03-31
Enrollment: 693
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Ambulatory Elderly subjects

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).

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 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

Primary outcomes:
measure: Circulating IGF-I and IGFBP-3 levels in AD patients and control elderly subjects at the time of assessment(T0).
timeFrame: 24 hours
Secondary outcomes:
measure: Circulating IGF-I and IGFBP-3 levels
timeFrame: 24 hours
measure: Genetic polymorphisms in IGF-I / IGFBP-3
timeFrame: 24 hours
measure: Circulating IGF-I and IGFBP-3 levels and genetic polymorphisms in IGF-I / IGFBP-3 according to cognitive function.
timeFrame: 24 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Broca Hospital Memory Clinic (CMRR)
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Olivier Hanon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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):139-46. doi: 10.1007/BF03343833.
citation: Duron E, Funalot B, Brunel N, Coste J, Quinquis L, Viollet C, Belmin J, Jouanny P, Pasquier F, Treluyer JM, Epelbaum J, le Bouc Y, Hanon O. Insulin-like growth factor-I and insulin-like growth factor binding protein-3 in Alzheimer's disease. J Clin Endocrinol Metab. 2012 Dec;97(12):4673-81. doi: 10.1210/jc.2012-2063. Epub 2012 Sep 26.