A Longitudinal Multidimensional Population Study on Brain Aging
NCT ID: NCT01345110
Last Updated: 2015-12-11
Study Results
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Basic Information
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COMPLETED
1321 participants
OBSERVATIONAL
2009-11-30
2015-12-31
Brief Summary
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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 )
Detailed Description
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Dementia is one of the most troubling neurodegenerative syndrome whose prevalence and incidence is strongly increasing. The etiology and physiopathology of the process that causes dementia are still controversial and largely unknown. So it is of paramount importance to isolate risk and protection factors related to dementia syndrome and Alzheimer disease. These meager known factors (biological, as well as social and neuropsychological) can be better investigated through a multidimensional longitudinal study in a homogeneous population by age and place.
Method:
People belonging to the selected population (1773 subjects living in Abbiategrasso and born between 1935 - 1939) were invited to participate at a comprehensive assessment which was divided in two appointments:
* a first appointment (about 1 hour and half) for blood sample, social questionnaire, anthropometric and walking speed evaluation ;
* a second one (2 hours)for clinical examination and neuropsychological assessment of mood and cognitive function.
Recruitment. People were recruited through several steps:
* involvement of the family doctor;
* a general call, based on age group(1935,1936, 1937, 1938, 1939), since to be born in the same year is an identity mark for these generations;
* kick-off meetings for each age class explaining aims and methods of the research, followed by a party with music, plays and some lotteries
* a letter with the date of the appointment followed by the phone call whenever the phone number is available
* further letters and call until either a rejection or an appointment was taken.
Assessment. Professionals and instruments:
* Trained interviewers, one social worker and two nurses, administer the social questionnaire that is partly derived from the CERAD and from other longitudinal studies.
* Trained psychologists administer a neuropsychological battery exploring mood (GDS 15 items), verbal and visual memory (Rey 15-item Memory Test, and the Rey-Osterrieth Complex Figure Test (ROCF) recall; Babcock Story Recall Test ), executive function ( TMTA and TMTB; copy of ROCF), attention (Numerical Attention), abstract reasoning (Raven's Coloured Progressive Matrices), screening cognitive test (Clock test and MMSE).
* Clinical interview and visit are executed by expert geriatricians, members of the same geriatric staff who apply diagnostic criteria for dementia (DSM IV), Alzheimer disease (NINCDS ADRDA diagnostic criteria); Vascular dementia (NINDS -AIREN criteria); Lewy Body dementia (third report, DLB consortium); frontotemporal dementia ( 2002 modified Consensus conference criteria). Other cognitive problems were classified as Mild Cognitive Impairment (MCI) following Petersen's criteria or Cognitive Impairment No Dementia (CIND) when cognitive impairments are in areas other than memory and they do not meet whole criteria for dementia. Every diagnostic conclusion is revised by another doctor; in case of discrepancies a third geriatrician, chief of the study, intervenes to arbitrate.
All the instruments were pre tested for inter rater reliability in a similar population attending a geriatric day hospital, and some general agreement sessions were performed before and during the screening.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* to be born between 1935 and 1939
Exclusion Criteria
* te be not contactable in any way (mail, telephone)
* to be legally resident, but actually living somewhere else
70 Years
75 Years
ALL
No
Sponsors
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Alzheimer Federation Italy
OTHER
Mario Negri Institute for Pharmacological Research
OTHER
University of Pavia
OTHER
Camillo Golgi Geriatric Institute
OTHER
Fondazione Golgi Cenci
OTHER
Responsible Party
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Antonio Guaita, MD
director
Principal Investigators
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ANTONIO GUAITA, MD
Role: STUDY_DIRECTOR
Golgi Cenci Foundation (research and study on aging)
Locations
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Golgi Cenci Foundation
Abbiategrasso, Milan, Italy
Countries
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References
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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
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.
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.
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.
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.
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.
Related Links
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official web site of the organization responsible for the study
official website of the caregivers organization, partner in the sponsorship of the research
Other Identifiers
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01
Identifier Type: -
Identifier Source: org_study_id