Alzheimer Disease Clinical Trial
Official title:
GERO Cohort Protocol, Chile, 2017 - 2019: Community-based Cohort of Functional Decline in Subjective Cognitive Complaint Elderly
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.
Status | Recruiting |
Enrollment | 300 |
Est. completion date | September 25, 2023 |
Est. primary completion date | September 25, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 70 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Chile | Universidad de Chile | Santiago | Metropolitan |
Lead Sponsor | Collaborator |
---|---|
Geroscience Center for Brain Health and Metabolism (Gero) |
Chile,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Longitudinal evolution of biomarkers and functional neuroimaging (fMRI) | 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. | Changes from baseline at 18 and 36 months. | |
Secondary | Evolution of the health-related quality of life: EQ3D | 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. | Changes from baseline at 18 and 36 months. | |
Secondary | Rate of cardiovascular events | Changes from baseline at 18 and 36 months. | ||
Secondary | Mortality rates | Changes from baseline at 18 and 36 months. |
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