DementiaInveCeAbNCT01345110
A Longitudinal Multidimensional Population Study on Brain Aging
An observational study of Dementia and Alzheimer Disease, run by Fondazione Golgi Cenci at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 70 to 75 years
- Conditions the study is for
- Dementia, Alzheimer Disease, Vascular Dementia
- How many people
- 1,321 participants
- Where
- 1 siteItaly
- Study dates
- Nov 2009to Dec 2015
- 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 70 to 75 years
- All sexes
- No healthy volunteers
- Older adult
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
Who may be able to join
- to be resident in Abbiategrasso
- to be born between 1935 and 1939
Who cannot join
- to refuse to participate
- te be not contactable in any way (mail, telephone)
- to be legally resident, but actually living somewhere else
Trial locations and contacts
1 site in 1 country.
About this study
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)
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 )
Read the 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.
- Conditions
- Dementia, Alzheimer Disease, Vascular Dementia
- Keywords
- dementia, mild cognitive impairment, prevalence, incidence, elderly, longitudinal study, population study
- Medical subject headings
- Dementia, Alzheimer Disease, Dementia, Vascular, Cognitive Dysfunction
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
- Screening cognitive tests: Clock test and MMSE.
- Memory tests: Babcock Story Recall Test , Rey 15-item Memory Test, and the Rey-Osterrieth Complex Figure Test (ROCF) recall.
- Executive tests:Trial making A and B; copy of ROCF
Measured: six years
Neuropsychological baseline features of the persons who will develop dementia or cognitive impairment
- Mood: GDS 15 items
- Verbal and visual memory: Babcock Story Recall Test, Rey 15-item Memory Test, and the Rey-Osterrieth Complex Figure Test (ROCF) recall
- 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
Measured: six years
Clinical baseline features of the persons who will develop dementia or cognitive impairment
- Index of co morbidities as defined by CIRS (Cumulative Index Rating Scale)
- Standard neurological examination
Measured: six years
Social baseline features of the persons who will developed dementia or cognitive impairment
- Stressful life events as defined in GALES (Geriatric Adverse Life Event Scale)
- Physical activity
- Social network
Measured: six years
Genetic baseline features of the persons who will developed dementia and/or cognitive impairment
- ApoE
- Inflammatory cytokines
Measured: six years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2011 (estimated)
- Study startNov 2009
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- 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
- 1,321 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione Golgi Cenci
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer Federation Italy, Mario Negri Institute for Pharmacological Research, University of Pavia, Camillo Golgi Geriatric Institute
- Responsible party
- Principal investigator, Antonio Guaita, MD, Fondazione Golgi Cenci
- Investigators
- ANTONIO GUAITA, MD, Study director, Golgi Cenci Foundation (research and study on aging)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01345110
- Sponsor's protocol ID
- 01
- Acronym
- InveCeAb
- Status last verified
- Dec 2015
- First submitted
- 21 Apr 2011
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24063518Guaita 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.
PubMed 25466513Valla 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.
PubMed 39784108Rolandi 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.
PubMed 39096236Rolandi 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.
PubMed 32767997
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01345110
- Acronym / sponsor ID
- InveCeAb / 01
- Conditions
- Dementia, Alzheimer Disease, Vascular Dementia
- Keywords
- dementia, mild cognitive impairment, prevalence, incidence, elderly, longitudinal study, population study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,321 participants (actual)
- Lead sponsor
- Fondazione Golgi CenciUniversity, hospital or other
- Collaborators
- Alzheimer Federation Italy, Mario Negri Institute for Pharmacological Research, University of Pavia, Camillo Golgi Geriatric Institute
- Study start
- Nov 2009
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 29 Apr 2011 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 70 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- 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
Key inclusion criteria (2 listed)
- to be resident in Abbiategrasso
- to be born between 1935 and 1939
Key exclusion criteria (3 listed)
- to refuse to participate
- te be not contactable in any way (mail, telephone)
- to be legally resident, but actually living somewhere else
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
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
Time frame: six years
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)
5 secondary outcomes
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
Time frame: six years
Neuropsychological baseline features of the persons who will develop dementia or cognitive impairment
Time frame: six years
Clinical baseline features of the persons who will develop dementia or cognitive impairment
Time frame: six years
Social baseline features of the persons who will developed dementia or cognitive impairment
Time frame: six years
Genetic baseline features of the persons who will developed dementia and/or cognitive impairment
Time frame: six years
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 Dec 2015.
- BackgroundGuaita 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: PubMed 24063518Guaita 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.
- Background: PubMed 25466513Guaita 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.
- Derived from this study: PubMed 39784108Valla 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.
- Derived from this study: PubMed 39096236Rolandi 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.
- Derived from this study: PubMed 32767997Rolandi 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.
- official web site of the organization responsible for the studyLink provided by the sponsor.
- official website of the caregivers organization, partner in the sponsorship of the researchLink provided by the sponsor.
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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.
ANTONIO GUAITA, MD study director
Golgi Cenci Foundation (research and study on aging)
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 Dementia and Alzheimer Disease, run by Fondazione Golgi Cenci at 1 site in Italy.
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 2 inclusion and 3 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 Dec 2015. 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 Italy. 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?
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 (time frame: six years). 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 NCT01345110, which also lists 6 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 Dec 2015; AzTrials last refreshed its copy on 31 Oct 2026.