A Longitudinal Multidimensional Population Study on Brain Aging

NCT01345110 | Completed DMC

• 1 other identifier: 01
• Study Type: observational
• Target: 1,321
• Locations: 1 country
• Sites: 1

Brief Summary

Longitudinal observational study of cognitive functions, physical health and biological parameters in the whole population living in Abbiategrasso born between 1935 and 1939,1773 subjects, followed for six years in order to know the prevalence and the incidence of dementia and risk and protective factors of normal and pathological mental aging. The peculiarities of this study that must assure the outcome efficacy are:

• Selected age: since 70-75 years old people represents a transition age from adulthood to old age, it is of special interest to study the evolution of psychic and physical functions of this population
• Whole population not a sample study
• Location: the small area involved (Abbiategrasso is a town of 30.000 inhabitants)can contribute to guarantee more homogeneity among the subjects and reduce undesired variability
• multidimensional assessment(biological, clinical, social, psychological data collected) After initial screening, the recruited population will be followed up for two more times (every two years )

Conditions

Dementia; Alzheimer Disease; Vascular Dementia

Keywords

dementia; mild cognitive impairment; prevalence; incidence; elderly; longitudinal study; population study

Outcome Measures

Primary Outcomes (1)

• The proportion of the recruited persons who will develop Dementia syndrome, Alzheimer disease, Vascular dementia, Lewy Body dementia, frontotemporal dementia, Mild Cognitive Impairment, Cognitive Impairment No Dementia

  These are the criteria used for the definitions : * DSM IV for Dementia syndrome * NINCDS ADRDA diagnostic criteria for Alzheimer disease * NINDS -AIREN criteria for Vascular dementia * Third report, DLB consortium for Lewy Body dementia * 2002 modified Consensus Conference criteria for frontotemporal dementia * Report of the MCI Working Group of the European Consortium on Alzheimer's Disease for Mild Cognitive Impairment (MCI) * Absence of the first criteria for MCI (subjective complain) for the definition of Cognitive Impairment No Dementia (CIND)

  six years

Secondary Outcomes (5)

• The proportion of persons who will exhibit a performance decrease equal or more than of 1,5 standard deviation of the mean in the reference population in screening cognitive tests or in memory tests (verbal and visual memory) or in executive tests

  six years

• Neuropsychological baseline features of the persons who will develop dementia or cognitive impairment

  six years

• Clinical baseline features of the persons who will develop dementia or cognitive impairment

  six years

• Social baseline features of the persons who will developed dementia or cognitive impairment

  six years

• Genetic baseline features of the persons who will developed dementia and/or cognitive impairment

  six years

Eligibility Criteria

• Age: 70 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the 1773 residents of Abbiategrasso, a town of 30.000 inhabitants near Milan, Lombardy, Italy, born from 1935 to 1939 : 1724 subjects meets the inclusion criteria

You may qualify if:

• to be resident in Abbiategrasso
• to be born between 1935 and 1939

You may not qualify if:

• to refuse to participate
• te be not contactable in any way (mail, telephone)
• to be legally resident, but actually living somewhere else

Sponsors & Collaborators

• Fondazione Golgi Cenci: lead
• Alzheimer Federation Italy: collaborator
• Mario Negri Institute for Pharmacological Research: collaborator
• University of Pavia: collaborator
• Camillo Golgi Geriatric Institute: collaborator

Study Sites (1)

Golgi Cenci Foundation

Abbiategrasso, Milan, 20081, Italy

Location

Related Publications (6)

• Guaita A, Forloni GL, Ferretti V, Villani S, Fossi S, Colombo M, Salvini Porro G InveCe.Ab: a multidimensional population study on brain aging for the 1935 - 1939 born people in a small town near Milan JNHA ( the Journal of Nutrition, Health &Aging) 2010; 14 (supplement 2): S17

  BACKGROUND

• Guaita A, Colombo M, Vaccaro R, Fossi S, Vitali SF, Forloni G, Polito L, Davin A, Ferretti VV, Villani S. Brain aging and dementia during the transition from late adulthood to old age: design and methodology of the "Invece.Ab" population-based study. BMC Geriatr. 2013 Sep 24;13:98. doi: 10.1186/1471-2318-13-98.

  PMID: 24063518 BACKGROUND

• Guaita A, Vaccaro R, Davin A, Colombo M, Vitali SF, Polito L, Abbondanza S, Valle E, Forloni G, Ferretti VV, Villani S. Influence of socio-demographic features and apolipoprotein E epsilon 4 expression on the prevalence of dementia and cognitive impairment in a population of 70-74-year olds: the InveCe.Ab study. Arch Gerontol Geriatr. 2015 Mar-Apr;60(2):334-43. doi: 10.1016/j.archger.2014.11.006. Epub 2014 Nov 25.

  PMID: 25466513 BACKGROUND

• Valla LG, Rossi M, Gaia A, Guaita A, Rolandi E. The Impact of the COVID-19 Pandemic on Oldest-Old Social Capital and Health and the Role of Digital Inequalities: Longitudinal Cohort Study. J Med Internet Res. 2025 Jan 9;27:e62824. doi: 10.2196/62824.

  PMID: 39784108 DERIVED

• Rolandi E, Rossi M, Colombo M, Pettinato L, Del Signore F, Aglieri V, Bottini G, Guaita A. Lifestyle, Cognitive, and Psychological Factors Associated With a Resilience Phenotype in Aging: A Multidimensional Approach on a Population-Based Sample of Oldest-Old (80+). J Gerontol B Psychol Sci Soc Sci. 2024 Oct 1;79(10):gbae132. doi: 10.1093/geronb/gbae132.

  PMID: 39096236 DERIVED

• Rolandi E, Zaccaria D, Vaccaro R, Abbondanza S, Pettinato L, Davin A, Guaita A. Estimating the potential for dementia prevention through modifiable risk factors elimination in the real-world setting: a population-based study. Alzheimers Res Ther. 2020 Aug 7;12(1):94. doi: 10.1186/s13195-020-00661-y.

  PMID: 32767997 DERIVED

Related Links

• official web site of the organization responsible for the study
• official website of the caregivers organization, partner in the sponsorship of the research

Biospecimen

Retention: SAMPLES WITH DNA

whole blood and serum

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Dementia, Vascular; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Cognition Disorders

Study Officials

• ANTONIO GUAITA, MD

  Golgi Cenci Foundation (research and study on aging)

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: April 21, 2011
• First Posted: April 29, 2011
• Study Start: November 1, 2009
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 11, 2015

Record last verified: 2015-12

Locations

IT (1)