- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01345110
A Longitudinal Multidimensional Population Study on Brain Aging (InveCeAb)
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 )
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Milan
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Abbiategrasso, Milan, Italy, 20081
- Golgi Cenci Foundation
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
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These are the criteria used for the definitions :
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six years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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six years
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Neuropsychological baseline features of the persons who will develop dementia or cognitive impairment
Time Frame: six years
|
|
six years
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Clinical baseline features of the persons who will develop dementia or cognitive impairment
Time Frame: six years
|
|
six years
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Social baseline features of the persons who will developed dementia or cognitive impairment
Time Frame: six years
|
|
six years
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Genetic baseline features of the persons who will developed dementia and/or cognitive impairment
Time Frame: six years
|
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six years
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: ANTONIO GUAITA, MD, Golgi Cenci Foundation (research and study on aging)
Publications and helpful links
General 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Neurocognitive Disorders
- Neurodegenerative Diseases
- Tauopathies
- Intracranial Arterial Diseases
- Intracranial Arteriosclerosis
- Leukoencephalopathies
- Dementia
- Alzheimer Disease
- Dementia, Vascular
Other Study ID Numbers
- 01 (Miami VAHS)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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