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A Longitudinal Multidimensional Population Study on Brain Aging (InveCeAb)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01345110
Recruitment Status : Completed
First Posted : April 29, 2011
Last Update Posted : December 11, 2015
Sponsor:
Collaborators:
Alzheimer Federation Italy
Mario Negri Institute for Pharmacological Research
University of Pavia
Camillo Golgi Geriatric Institute
Information provided by (Responsible Party):
Antonio Guaita, MD, Fondazione Golgi Cenci

Tracking Information
First Submitted Date April 21, 2011
First Posted Date April 29, 2011
Last Update Posted Date December 11, 2015
Study Start Date November 2009
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 28, 2011)
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)
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 28, 2011)
  • 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 ]
    • 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 ]
    • 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 ]
    • 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 ]
    • 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 ]
    • ApoE
    • Inflammatory cytokines
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Longitudinal Multidimensional Population Study on Brain Aging
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)
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 )
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
whole blood and serum
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
Condition
  • Dementia
  • Alzheimer Disease
  • Vascular Dementia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 10, 2015)
1321
Original Estimated Enrollment
 (submitted: April 28, 2011)
1322
Actual Study Completion Date December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 70 Years to 75 Years   (Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT01345110
Other Study ID Numbers 01
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Antonio Guaita, MD, Fondazione Golgi Cenci
Study Sponsor Fondazione Golgi Cenci
Collaborators
  • Alzheimer Federation Italy
  • Mario Negri Institute for Pharmacological Research
  • University of Pavia
  • Camillo Golgi Geriatric Institute
Investigators
Study Director: ANTONIO GUAITA, MD Golgi Cenci Foundation (research and study on aging)
PRS Account Fondazione Golgi Cenci
Verification Date December 2015