Clinical trial NCT01345110: A Longitudinal Multidimensional Population Study on Brain Aging
Official title: A Longitudinal Population Study on Brain Aging and Mental Performances for the 1935-1939 Born People Living in Abbiategrasso (a Small Town Near Milan)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dementia
Alzheimer Disease
Vascular Dementia
Keywords: dementia
mild cognitive impairment
prevalence
incidence
elderly
longitudinal study
population study
Lead sponsor: Fondazione Golgi Cenci
Sponsor class: OTHER
Collaborators: name: Alzheimer Federation Italy
name: Mario Negri Institute for Pharmacological Research
name: University of Pavia
name: Camillo Golgi Geriatric Institute
First posted: 2011-04-29
Enrollment: 1321
Sex: ALL
Minimum age (years): 70
Maximum age (years): 75
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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 )

Detailed description: Background:

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: 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
timeFrame: six years
Secondary outcomes:
measure: 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
timeFrame: six years
measure: Neuropsychological baseline features of the persons who will develop dementia or cognitive impairment
timeFrame: six years
measure: Clinical baseline features of the persons who will develop dementia or cognitive impairment
timeFrame: six years
measure: Social baseline features of the persons who will developed dementia or cognitive impairment
timeFrame: six years
measure: Genetic baseline features of the persons who will developed dementia and/or cognitive impairment
timeFrame: six years
Other outcomes:
Locations:
city: Abbiategrasso
country: Italy
facility: Golgi Cenci Foundation
state: Milan
Study officials:
affiliation: Golgi Cenci Foundation (research and study on aging)
name: ANTONIO GUAITA, MD
role: STUDY_DIRECTOR
References:
citation: 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
citation: 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.
citation: 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.
citation: 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.