Cognitive Health in Ageing Register: Investigational, Observational and Trial Studies in Dementia Research: Prospective Readiness Cohort Study
This trial is active, not recruiting.
|Sponsor||Janssen Research & Development, LLC|
|Start date||March 2014|
|End date||March 2018|
|Trial size||1200 participants|
|Trial identifier||NCT02114372, CR104383, REGISTRYALZ0001, RRA-11823|
The purpose of this study is to investigate the natural history of cognitive and functional changes in participants at risk for developing mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (MCI-AD).
|Observational model||ecologic or community|
Change from baseline cognition
time frame: Up to 4 years
Male or female participants from 60 years up to 72 years old.
Inclusion criteria: - Enrolled in the CHARIOT Register - Willing and able to give written informed consent - Meets the definition for inclusion in the low risk, medium risk, or high risk cohorts according to criteria specified in the protocol Exclusion Criteria: - Concurrent participation in a clinical trial - Diagnosis of Dementia - Past or current use of memantine or cholinesterase inhibitors - Diagnosis of other neurologic disease or conditions known to cause or be associated with dementia, such as Parkinson's disease - History of traumatic brain injury with residual neurological deficit or stroke
|Official title||Cognitive Health in Ageing Register: Investigational, Observational and Trial Studies in Dementia Research (CHARIOT): Prospective Readiness Cohort Study (PRO)|
|Description||This is a prospective single center study that will enroll participants without dementia who are considered at high, medium and low risk for developing mild cognitive impairment (MCI) due to Alzheimer's disease (AD) from a community-based register (referred to as the CHARIOT registry) in the United Kingdom. No interventions (ie, study drugs) will be administered to participants in the study. The planned duration of the study is approximately 4 years with up to 2 years for participant recruitment. Data collection to assess outcome measures associated with disease progression will occur at baseline and every 6 months thereafter at the clinic during the follow-up period of 48 months. Blood, urine, and saliva samples will be collected from participants during the study for biomarker analyses to assess risk factors for dementia, Alzheimer's disease or confounding factors of dementia risk. Adverse events experienced by the participants during their participation in the study will be monitored.|
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