InveCeAb: A Longitudinal Multidimensional Population Study on Brain Aging

Sponsor

Fondazione Golgi Cenci (Other)

Overall Status

Completed

CT.gov ID

NCT01345110

Collaborator

Alzheimer Federation Italy (Other), Mario Negri Institute for Pharmacological Research (Other), University of Pavia (Other), Camillo Golgi Geriatric Institute (Other)

1,321

Enrollment

Location

Duration (Months)

18.1

Patients Per Site Per Month

Study Details

Study Description

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 )

Condition or Disease	Intervention/Treatment	Phase
Dementia Alzheimer Disease Vascular Dementia

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

Study Type:

Observational

Actual Enrollment :

1321 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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 Start Date :

Nov 1, 2009

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Outcome Measures

Primary Outcome Measures

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 [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)

Secondary Outcome Measures

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 [six years]
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
Neuropsychological baseline features of the persons who will develop dementia or cognitive impairment [six years]
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
Clinical baseline features of the persons who will develop dementia or cognitive impairment [six years]
Index of co morbidities as defined by CIRS (Cumulative Index Rating Scale) Standard neurological examination
Social baseline features of the persons who will developed dementia or cognitive impairment [six years]
Stressful life events as defined in GALES (Geriatric Adverse Life Event Scale) Physical activity Social network
Genetic baseline features of the persons who will developed dementia and/or cognitive impairment [six years]
ApoE Inflammatory cytokines