Alzheimer's DiseaseSIGALNCT00647478
System-IGF-1 Pathway and Alzheimer's Disease
An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Mild Cognitive Impairment, Cognitive Function 1, Social
- How many people
- 693 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2007to Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Ambulatory Elderly subjects
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
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).
Read the 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.
- 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
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | AD | |
| 2 | Control elderly subjects with normal cognitive function | |
| 3 | MCI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Circulating IGF-I and IGFBP-3 levels in AD patients and control elderly subjects at the time of assessment(T0).
Measured: 24 hours
Secondary outcomes (3)
Circulating IGF-I and IGFBP-3 levels
Measured: 24 hours
Genetic polymorphisms in IGF-I / IGFBP-3
Measured: 24 hours
Circulating IGF-I and IGFBP-3 levels and genetic polymorphisms in IGF-I / IGFBP-3 according to cognitive function.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2008 (estimated)
- Study startOct 2007
- Primary completionOct 2010
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 693 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Responsible party
- Sponsor
- Investigators
- Olivier Hanon, MD, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00647478
- Sponsor's protocol ID
- P060224
- Acronym
- SIGAL
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2008
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 11314741Duron E, Vidal JS, Funalot B, Brunel N, Viollet C, Rigaud AS, Labouree F, Epelbaum J, le Bouc Y, Hanon O. Insulin-Like Growth Factor-I, Insulin-Like Growth factor Binding Protein-3 and Blood Hemoglobin Concentration in an Elderly Population. J Gerontol A Biol Sci Med Sci. 2015 Jul;70(7):854-9. doi: 10.1093/gerona/glu200. Epub 2014 Nov 9.
PubMed 25384548Duron 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.
PubMed 23015654
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00647478
- Acronym / sponsor ID
- SIGAL / P060224
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 693 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- URC-CIC Paris Descartes Necker Cochin
- Study start
- Oct 2007 (actual)
- Primary completion
- Oct 2010 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 31 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –AD |
| 2 | – | –Control elderly subjects with normal cognitive function |
| 3 | – | –MCI |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Ambulatory Elderly subjects
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Circulating IGF-I and IGFBP-3 levels in AD patients and control elderly subjects at the time of assessment(T0).
Time frame: 24 hours
3 secondary outcomes
Circulating IGF-I and IGFBP-3 levels
Time frame: 24 hours
Genetic polymorphisms in IGF-I / IGFBP-3
Time frame: 24 hours
Circulating IGF-I and IGFBP-3 levels and genetic polymorphisms in IGF-I / IGFBP-3 according to cognitive function.
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Background: PubMed 11314741Murialdo 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.
- Results publication: PubMed 25384548Duron E, Vidal JS, Funalot B, Brunel N, Viollet C, Rigaud AS, Labouree F, Epelbaum J, le Bouc Y, Hanon O. Insulin-Like Growth Factor-I, Insulin-Like Growth factor Binding Protein-3 and Blood Hemoglobin Concentration in an Elderly Population. J Gerontol A Biol Sci Med Sci. 2015 Jul;70(7):854-9. doi: 10.1093/gerona/glu200. Epub 2014 Nov 9.
- Results publication: PubMed 23015654Duron 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Hanon, MD, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Mild Cognitive Impairment, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00647478, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2026.