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Community-based Cohort of Functional Decline in Subjective Cognitive Complaint Elderly

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04265482
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
Information provided by (Responsible Party):
Geroscience Center for Brain Health and Metabolism (Gero)

Brief Summary:

Background With the global population aging and life expectancy increasing, dementia has turned a priority in the health care system. In Chile, dementia is one of the most important causes of disability in elderly, corresponding nearly to 40% of cases, and the most rapidly growing cause of death in the last twenty years. Cognitive complaints are considered a marker able to predict cognitive and functional decline, incident mild cognitive impairment (MCI), and incident dementia. The Gero cohort is the Chilean core clinical project of the Gerocenter on Brain Health and Metabolism (GERO), whose aim is to establish the capacity in Chile to foster cutting edge and multidisciplinary research on aging.

Objective This study has two main objectives. First, i) to analyze the rate of functional decline and progression to clinical dementia and their risks factors (biomedical, imaging, psychosocial, and clinical) in a community-dwelling elderly with subjective cognitive complaint, through a population-based study. Second, ii) to build the capacity to undertake clinical research on brain aging and dementia disorders and create Data-Bank and Bio-Banks with an appropriate infrastructure to further studies and facilitate access to the data and samples for research.

Methods The Gero cohort aims at recruiting 300 elderly subjects (>70 years) from the community of Santiago (Chile), following them up for at least 3 years. Eligible people are non-demented adults with subjective cognitive complaint, which are reported either by the participant, the proxy or both. Participants are identified through a household census. The protocol of evaluation is based on a multidimensional approach including socio-demographic, biomedical, psychosocial, neuropsychological, neuropsychiatric and motor assessments. Neuroimaging, blood and stool sample samples are also included. This multidimensional evaluation is carried out in a baseline assessment and 3 follow-ups assessment, at 18 and 36 months. In addition, in months 6, 24, and 30, a telephone interview is done in order to keep contact with the participants and to assess general well-being.

Condition or disease
Subjective Cognitive Complaint Activities Daily Living Dementia Alzheimer Disease Neurodegenerative Diseases Functionality Gait Disorders, Neurologic Geroscience

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: GERO Cohort Protocol, Chile, 2017 - 2019: Community-based Cohort of Functional Decline in Subjective Cognitive Complaint Elderly
Actual Study Start Date : September 25, 2017
Estimated Primary Completion Date : September 25, 2020
Estimated Study Completion Date : September 25, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Primary Outcome Measures :
  1. Rate of functional decline and progression to clinical dementia [ Time Frame: Changes from baseline at 18 and 36 months. ]
    The protocol considers an intensive and deep multidimensional study of factors related to the prognosis of functional decline and dementia development. The range of assessments includes: sociodemographic, psychosocial, neuropsychological, neuropsychiatric, motor, neuroimaging, blood biomarkers, genetic and stool samples to perform gut microbiome studies.

Secondary Outcome Measures :
  1. Longitudinal evolution of biomarkers and functional neuroimaging (fMRI) [ Time Frame: Changes from baseline at 18 and 36 months. ]
    Gero biological samples of whole blood, buffy coat, plasma, serum, and peripheral mononuclear cells are taken and processed according to the guidelines published in 2015. Samples are, stored in our Gero biobank for long-term storage at -80 °C or in liquid nitrogen. Stool samples will be collected using standardized kits and DNA extracted using the protocol Q suggested by the international human microbiome standards (IHMS SOP 06 V1). Neuroimaging protocol will allow assessing brain atrophy, structural and functional connectivity and white matter lesions.

  2. Evolution of the health-related quality of life: EQ3D [ Time Frame: Changes from baseline at 18 and 36 months. ]
    Health related quality of life will be assessed using the EQ3D and monitored by a period telephone contact. EQ3D is a standardized instrument for measuring generic health status, where 0% is the worst possible health self-perception and 100% is the best health self-perception.

  3. Rate of cardiovascular events [ Time Frame: Changes from baseline at 18 and 36 months. ]
  4. Mortality rates [ Time Frame: Changes from baseline at 18 and 36 months. ]

Biospecimen Retention:   Samples With DNA
Whole blood, buffy coat, plasma, serum, peripheral mononuclear cells, stool samples.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   70 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The cohort recruits the potential participants from the general population, using a door-to-door strategy. The sample framework corresponds to the territories assigned to three primary healthcare centres selected by convenience according to their socioeconomic heterogeneity, which belong to three different districts in Santiago (Chile): Macul, Peñalolen and La Reina. The sample considered a two-stage selection process. The first stage included a sample of quadrants within each territory, where the contact to all houses was attempted. The second stage proceeded when in a home was found more than one potential eligible participant, choosing one randomly. Territories encompassed a population between 14,937 and 39,458 people. of which between 4.6% and 8.0% is expected to be older than 70.

Inclusion Criteria:

  • 70 years old or older.
  • Presence of a knowledgeable informant and/or presence of a contact that allows the follow up of the participant.
  • Being affiliated to the public health insurance.
  • Subjective cognitive complaint either self-reported or reported by a knowledgeable informant.
  • Clinical Dementia Scale— frontotemporal lobar degeneration (CDR-FTLD) equal or inferior to 0.5.
  • Signed informed consent

Exclusion Criteria:

  • Report of medical diagnosis of dementia.
  • Mini-mental State Examination (MMSE) < 21 and Pfeffer questionnaire >2.
  • Institutionalization (for example, living in an elderly home or a skilled nursing facility)
  • Illiteracy, meaning that is not able to count or to read.
  • Visual and auditory acuity not adequate for neuropsychological testing.
  • Important limitation of mobility incompatible with the availability to be independent in daily life activities or attending a clinical centre for further evaluation.
  • Report of medical diagnosis of Parkinson's disease.
  • Report of medical diagnosis of one or more of the following conditions causing severe impairment in functionality: any psychiatric or neurological disorders, brain tumor, subdural haematoma, progressive supranuclear palsy, or history of head trauma.
  • Report of medical diagnosis of stroke occurred in the last three months.
  • Presence of a fatal disease (less than one year of survival)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04265482

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Contact: Teresa Parrao, PhD. +56229770574
Contact: Carolina Toledo +5622970559

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Universidad de Chile Recruiting
Santiago, Metropolitan, Chile, 7500000
Contact: Andrea Slachevsky, MD    229770574   
Contact: Carolina Toledo    +569770559   
Sponsors and Collaborators
Geroscience Center for Brain Health and Metabolism (Gero)
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Principal Investigator: Andrea Slachevsky, MD Geroscience Center for Brain health and Metabolism

Browne, W.J., MCMC Estimation in MLwiN (Version 2.13) Centre for Multilevel Modelling. 2015, Bristol, UK: Centre for Multilevel Modelling, University of Bristol.
Christensen, R., et al., Bayesian Ideas and Data Analysis: An Introduction for Scientists and Statisticians. . 2010, U.S.A: CRC Press
James, G., et al., An Introduction to Statistical Learning with Applications in R. . Springer Texts in Statistics. 2017: Springer.
Hoyle, R.H., Handbook of Structural Equation Modeling. . 2012: The Guilford Press.
Steyerberg, E., Clinical Prediction Model: Ch. 8: Case Study on Dealing with Missing Data. Statistics for Biology and Health, 2009: p. 139 - 158.
Steyerberg, E., Clinical Prediction Models: Ch. 7: A Practical Approach to Development, Validation, and Updating. Statistics for Biology and Health, 2009: p. 115 - 137.

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Responsible Party: Geroscience Center for Brain Health and Metabolism (Gero) Identifier: NCT04265482    
Other Study ID Numbers: FONDAP 15150012
First Posted: February 11, 2020    Key Record Dates
Last Update Posted: February 11, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geroscience Center for Brain Health and Metabolism (Gero):
Cognitive Ageing
Subjective Cognitive Complaint
Functional decline
Additional relevant MeSH terms:
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Alzheimer Disease
Neurodegenerative Diseases
Gait Disorders, Neurologic
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurologic Manifestations
Signs and Symptoms