A Longitudinal Multidimensional Population Study on Brain Aging

Alzheimer Disease Clinical Trial

— InveCeAb  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01345110
• Other study ID #: 01
• Status: Completed
• Phase: N/A
• First received: April 21, 2011
• Last updated: December 10, 2015
• Start date: November 2009
• Est. completion date: December 2015

Study information

• Verified date: December 2015
• Source: Fondazione Golgi Cenci
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Observational

Clinical 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 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 )

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1321
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 70 Years to 75 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Dementia, Vascular
• Vascular Dementia

Locations

Country	Name	City	State
Italy	Golgi Cenci Foundation	Abbiategrasso	Milan

Sponsors (5)

Lead Sponsor	Collaborator
Fondazione Golgi Cenci	Federazione Alzheimer Italia, Milan (Italy), Geriatric Institute Camillo Golgi, Abbiategrasso, Milan (Italy), Mario Negri Institute for Pharmacological Research, University of Pavia

Country where clinical trial is conducted

Italy, 

References & Publications (3)

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. — View 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

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	six years	No
Secondary	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	six years	No
Secondary	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	six years	No
Secondary	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	six years	No
Secondary	Genetic baseline features of the persons who will developed dementia and/or cognitive impairment	ApoE; Inflammatory cytokines	six years	No

External Links

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