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

NCT04265482 | Unknown DMC

• 1 other identifier: FONDAP 15150012
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Cognitive Ageing; Subjective Cognitive Complaint; Dementia; Alzheimer; Functional decline; Geroscience

Outcome Measures

Primary Outcomes (1)

• Rate of functional decline and progression to clinical dementia

  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.

  Changes from baseline at 18 and 36 months.

Secondary Outcomes (4)

• Longitudinal evolution of biomarkers and functional neuroimaging (fMRI)

  Changes from baseline at 18 and 36 months.

• Evolution of the health-related quality of life: EQ3D

  Changes from baseline at 18 and 36 months.

• Rate of cardiovascular events

  Changes from baseline at 18 and 36 months.

• Mortality rates

  Changes from baseline at 18 and 36 months.

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Geroscience Center for Brain Health and Metabolism (Gero): lead

Study Sites (1)

Universidad de Chile

Santiago, Metropolitan, 7500000, Chile

RECRUITING

Related Publications (10)

• Pievani M, Filippini N, van den Heuvel MP, Cappa SF, Frisoni GB. Brain connectivity in neurodegenerative diseases--from phenotype to proteinopathy. Nat Rev Neurol. 2014 Nov;10(11):620-33. doi: 10.1038/nrneurol.2014.178. Epub 2014 Oct 7.

  PMID: 25287597 BACKGROUND

• Ferrarini L, van Lew B, Reiber JH, Gandin C, Galluzzo L, Scafato E, Frisoni GB, Milles J, Pievani M; IPREA Working Group (Italian PRoject on Epidemiology of Alzheimer's disease). Hippocampal atrophy in people with memory deficits: results from the population-based IPREA study. Int Psychogeriatr. 2014 Jul;26(7):1067-81. doi: 10.1017/S1041610213002627. Epub 2014 Feb 13.

  PMID: 24524645 BACKGROUND

• O'Bryant SE, Gupta V, Henriksen K, Edwards M, Jeromin A, Lista S, Bazenet C, Soares H, Lovestone S, Hampel H, Montine T, Blennow K, Foroud T, Carrillo M, Graff-Radford N, Laske C, Breteler M, Shaw L, Trojanowski JQ, Schupf N, Rissman RA, Fagan AM, Oberoi P, Umek R, Weiner MW, Grammas P, Posner H, Martins R; STAR-B and BBBIG working groups. Guidelines for the standardization of preanalytic variables for blood-based biomarker studies in Alzheimer's disease research. Alzheimers Dement. 2015 May;11(5):549-60. doi: 10.1016/j.jalz.2014.08.099. Epub 2014 Oct 1.

  PMID: 25282381 BACKGROUND

• Browne, W.J., MCMC Estimation in MLwiN (Version 2.13) Centre for Multilevel Modelling. 2015, Bristol, UK: Centre for Multilevel Modelling, University of Bristol.

  BACKGROUND

• Christensen, R., et al., Bayesian Ideas and Data Analysis: An Introduction for Scientists and Statisticians. . 2010, U.S.A: CRC Press

  BACKGROUND

• James, G., et al., An Introduction to Statistical Learning with Applications in R. . Springer Texts in Statistics. 2017: Springer.

  BACKGROUND

• Hoyle, R.H., Handbook of Structural Equation Modeling. . 2012: The Guilford Press.

  BACKGROUND

• Steyerberg, E., Clinical Prediction Model: Ch. 8: Case Study on Dealing with Missing Data. Statistics for Biology and Health, 2009: p. 139 - 158.

  BACKGROUND

• Steyerberg, E., Clinical Prediction Models: Ch. 7: A Practical Approach to Development, Validation, and Updating. Statistics for Biology and Health, 2009: p. 115 - 137.

  BACKGROUND

• Slachevsky A, Zitko P, Martinez-Pernia D, Forno G, Court FA, Lillo P, Villagra R, Duran-Aniotz C, Parrao T, Assar R, Orellana P, Toledo C, Rivera R, Ibanez A, Parra MA, Gonzalez-Billault C, Amieva H, Thumala D. GERO Cohort Protocol, Chile, 2017-2022: Community-based Cohort of Functional Decline in Subjective Cognitive Complaint elderly. BMC Geriatr. 2020 Nov 25;20(1):505. doi: 10.1186/s12877-020-01866-4.

  PMID: 33238908 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood, buffy coat, plasma, serum, peripheral mononuclear cells, stool samples.

MeSH Terms

Conditions

Dementia; Alzheimer Disease; Neurodegenerative Diseases; Gait Disorders, Neurologic

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Andrea Slachevsky, MD

  Geroscience Center for Brain health and Metabolism

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Teresa Parrao, PhD.

CONTACT

+56229770574; teresaparrao@gmail.com

Carolina Toledo

CONTACT

+5622970559; ctoledosar@uchile.cl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 11, 2020
• Study Start: September 25, 2017
• Primary Completion: September 25, 2020
• Study Completion: September 25, 2023
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

CL (1)