A Longitudinal Multidimensional Population Study on Brain Aging (InveCeAb)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Federazione Alzheimer Italia, Milan (Italy)
Mario Negri Institute for Pharmacological Research
University of Pavia
Geriatric Institute Camillo Golgi, Abbiategrasso, Milan (Italy)
Information provided by (Responsible Party):
Antonio Guaita, MD, Fondazione Golgi Cenci
ClinicalTrials.gov Identifier:
NCT01345110
First received: April 21, 2011
Last updated: October 23, 2013
Last verified: October 2013
  Purpose

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
Dementia
Alzheimer Disease
Vascular Dementia

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by Fondazione Golgi Cenci:

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 [ Time Frame: six years ] [ Designated as safety issue: No ]

    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 [ Time Frame: six years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: six years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: six years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: six years ] [ Designated as safety issue: No ]
    • 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 [ Time Frame: six years ] [ Designated as safety issue: No ]
    • ApoE
    • Inflammatory cytokines


Biospecimen Retention:   Samples With DNA

whole blood and serum


Estimated Enrollment: 1322
Study Start Date: November 2009
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   70 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01345110

Locations
Italy
Golgi Cenci Foundation
Abbiategrasso, Milan, Italy, 20081
Sponsors and Collaborators
Fondazione Golgi Cenci
Federazione Alzheimer Italia, Milan (Italy)
Mario Negri Institute for Pharmacological Research
University of Pavia
Geriatric Institute Camillo Golgi, Abbiategrasso, Milan (Italy)
Investigators
Study Director: ANTONIO GUAITA, MD Golgi Cenci Foundation (research and study on aging)
  More Information

Additional Information:
Publications:
Responsible Party: Antonio Guaita, MD, director, Fondazione Golgi Cenci
ClinicalTrials.gov Identifier: NCT01345110     History of Changes
Other Study ID Numbers: 01
Study First Received: April 21, 2011
Last Updated: October 23, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by Fondazione Golgi Cenci:
dementia
mild cognitive impairment
prevalence
incidence
elderly
longitudinal study
population study

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 29, 2014