Clinical Trial: Cognitive Health in Ageing Register: Investigational, Observational and Trial Studies in Dementia Research: Prospective Readiness Cohort Study

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Cognitive Health in Ageing Register: Investigational, Observational and Trial Studies in Dementia Research (CHARIOT): Prospective Readiness Cohort Study (PRO)

Brief Summary:

The purpose of this study is (i) Main Study: To describe the baseline characteristics (including demographics, cognitive status, and other measures) and the cognitive and functional changes of persons at risk for developing Alzheimer's disease (AD).

(ii) SubStudy: To investigate the longitudinal change of the components of the Alzheimer Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC) and the components of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) in asymptomatic at risk for AD (ARAD) individuals compared with individuals not classified as ARAD.

(iii) Neurovision Ancillary Study: To explore correlation between retinal amyloid beta plaques identified by fluorescence with amyloid positron emission tomography (PET) Standardized Uptake Value Ratio (SUVR) and cerebrospinal fluid (CSF) amyloid beta 42 testing in participants at risk for Alzheimer's dementia.

Detailed Summary: This is a prospective, non-interventional study consisting of a Main Study, a SubStudy, and an Ancillary Study that will enroll participants without dementia who are considered at high, medium, and low risk for developing AD from a community based register (referred to as the CHARIOT registry) in the United Kingdom. The Main Study will be conducted only at one site and the SubStudy and the Ancillary Study will be conducted at two sites. Participants in both the Main Study and the SubStudy will undergo a series of neuropsychological evaluations to characterize the patterns of cognitive change and their inter-relationship in the earliest stages of cognitive impairment. The SubStudy will investigate the longitudinal change of components of the ADCS-PACC and RBANS in ARAD individuals who have demonstrable amyloid in the brain by either PET or CSF compared with individuals not classified as ARAD. The Ancillary Study will explore how measures of retinal amyloid plaques relate to cerebellar amyloid SUVR taken from PET imaging or with amyloid beta 42 levels measured in CSF. 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 (Main Study). SubStudy participants will be followed every 3 months throughout the SubStudy and will alternate between completing the alternative forms of the ADCS-PACC and RBANS for a period of up to 3.5 years. Ancillary Study participants will be followed on Day 1, Days 4-15 and a follow-up call (greater than [30] and less than [<] 35 days after Visit 2). 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.
Sponsor: Janssen Research & Development, LLC

Current Primary Outcome:

• Main Study: Change From Baseline Cognition [ Time Frame: Up to 4 years ]
  Cognition will be evaluated at baseline and longitudinally with the Mini-Mental State Examination (MMSE), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Neuropsychological Assessment Battery (NAB)-Executive Function module, NAB-Memory module, CogState Brief Battery (CBB), Clinical Drug Research Assessment System (CDR-AS), and Delis Kaplan Executive Function System (DKEFS), as well as the Clinical Dementia Rating Scale.
• SubStudy: Change From Baseline on Alzheimer Disease Cooperative Study Preclinical Alzheimer Cognitive Composite (ADCS-PACC) Component Score [ Time Frame: Up to 3.5 years ]
  ADCS-PACC is a composite measure that assesses episodic memory, executive functioning, and global cognition. The ADCS-PACC includes: 1. Total Recall score from the Free and Cued Selective Reminding Test (0-48 words); 2. Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (0-25 story units); 3. Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale-Revised (0-93 symbols), and 4. MMSE score (0-30 points). The component scores are transformed using an established normalization method. Each of the 4 component change scores is divided by the baseline sample standard deviation of that component. Z-score implies how many standard deviations higher or lower the score is compared with the baseline score.
• SubStudy: Change From Baseline in Repeatable Battery for the Assessment of Neuropsychological Status-Preclinical Alzheimer Cognitive Composite (RBANS-PACC) Component Score [ Time Frame: Up to 3.5 years ]
  Cognition will be evaluated at baseline and longitudinally with the Mini-Mental State Examination (MMSE), Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), Neuropsychological Assessment Battery (NAB)-Executive Function module, NAB-Memory module, CogState Brief Battery (CBB), Clinical Drug Research Assessment System (CDR-Assessment System), and Delis Kaplan Executive Function System (DKEFS), as well as the Clinical Dementia Rating Scale.
  
  
  

  Current Secondary Outcome:

  • SubStudy: Change From Baseline on the RBANS-PACC Composite Score [ Time Frame: Up to 3.5 years ]
    This brief test is to assess areas of cognitive assessment, detection, and characterization of dementia in the elderly as well as neuropsychological screening for younger patients. The RBANS-PACC includes: 1. RBANS List Learning; 2. RBAN Story Memory; 3. RBANS Coding; and MMSE total score. The composite score is determined from its components using an established normalization method. Each of the 4 component change scores is divided by the baseline sample standard deviation of that component, to form standardized z-scores. Z-score implies how many standard deviations higher or lower the score is compared with baseline score. The composite score is a sum of z-scores for component scores. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite.
  • SubStudy: Change From Baseline on the ADCS-PACC Composite Score [ Time Frame: Up to 3.5 years ]
    The ADCS-PACC is a composite measure that assesses episodic memory, executive functioning, and global cognition. The ADCS-PACC includes: 1. Total Recall score from Free and Cued Selective Reminding Test (0-48 words); 2. Delayed Recall score on the Logical Memory IIa subtest from the Wechsler Memory Scale (0-25 story units); 3. Digit Symbol Substitution Test score from Wechsler Adult Intelligence Scale-Revised (0-93 symbols) and 4. MMSE total score (0-30 points). The composite score is determined from its components using an established normalization method. Each of the 4 component change scores is divided by the baseline sample standard deviation of that component, to form standardized z-scores. Z-score implies how many standard deviations higher or lower the score is compared with baseline score. The composite score is a sum of z-scores for component scores. Thus, a change of 1 baseline standard deviation on each component would correspond to a 4-point change on the composite.
  
  
  

  Original Secondary Outcome:
  
  Information By: Janssen Research & Development, LLC
  

  Dates:
  Date Received: April 11, 2014
  Date Started: February 5, 2014
  Date Completion: August 27, 2021
  Last Updated: May 17, 2017
  Last Verified: May 2017