Community-based Cohort of Functional Decline in Subjective Cognitive Complaint Elderly
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|ClinicalTrials.gov Identifier: NCT04265482|
Recruitment Status : Recruiting
First Posted : February 11, 2020
Last Update Posted : February 11, 2020
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|
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|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|
- 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.
- 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.
- 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.
- Rate of cardiovascular events [ Time Frame: Changes from baseline at 18 and 36 months. ]
- Mortality rates [ Time Frame: Changes from baseline at 18 and 36 months. ]
Biospecimen Retention: Samples With DNA
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 ClinicalTrials.gov identifier (NCT number): NCT04265482
|Contact: Teresa Parrao, PhD.||+firstname.lastname@example.org|
|Contact: Carolina Toledoemail@example.com|
|Principal Investigator:||Andrea Slachevsky, MD||Geroscience Center for Brain health and Metabolism|