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

NCT02114372 | Completed

• 2 other identifiers: CR104383REGISTRYALZ0001; RRA-11823
• Study Type: observational
• Target: 1,136
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to prospectively investigate the longitudinal change of the components of the Preclinical Alzheimer Cognitive Composite (PACC) and the components (index scores) of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) in asymptomatic at risk for Alzheimer's disease (ARAD) individuals.

Conditions

Alzheimer's Disease; Plaque, Amyloid

Keywords

Alzheimer's disease; Asymptomatic at risk for Alzheimer's disease; Retinal diagnosis for Alzheimer's disease

Outcome Measures

Primary Outcomes (3)

• Main Study: Change From Baseline Cognition

  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), Cognitive Drug Research Assessment System (CDR-AS), and Delis Kaplan Executive Function System (DKEFS), as well as the Clinical Dementia Rating Scale.

  Up to 4 years

• SubStudy: Change From Baseline on Preclinical Alzheimer Cognitive Composite (PACC) Component Score

  The PACC is a retrospectively validated measure that is weighted towards episodic memory, and also includes a timed executive function test and a global cognitive screening test. The PACC includes: 1. Total Recall score from the Free and Cued Selective Reminding Test - Immediate Recall \[FCSRT-IR\] (0-48 words); 2. Delayed Paragraph Recall total score on single administration of the Logical Memory story from the Wechsler Memory Scale \[WMS\]-Revised (0-25 story units); 3. Digit Symbol Substitution Test score from the Wechsler Adult Intelligence Scale \[WAIS\]-Revised (0-135 symbols), and 4. MMSE score (0-30 points). The component scores are transformed using an established normalization method into z-scores. 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.

  Baseline and Month 42 (Year 3.5)

• SubStudy: Change From Baseline in RBANS Index Scores

  This brief test is for cognitive assessment, detection, and characterization of dementia in the elderly as well as neuropsychological screening for younger patients. The RBANS Index scores include Immediate Memory Index, Visuospatial/Construction Index, Language Index, Attention Index and the Delayed Memory Index. The sum of these 5 Index scores is converted to a Total Scale value via a mapping table. The Total Scale is a norm-based t score based on a distribution with a mean of 100 and standard deviation of 15.

  Baseline and Month 42 (Year 3.5)

Secondary Outcomes (2)

• SubStudy: Change From Baseline on the RBANS Total Scale

  Baseline and Month 42 (Year 3.5)

• SubStudy: Change From Baseline on the PACC Composite Score

  Baseline and Month 42 (Year 3.5)

Study Arms (4)

CogState Brief Battery

Enrolled participants will be randomized in a balanced manner to CogState brief battery in both the Main Study and the SubStudy. CogState consists of four tasks that respectively measure the functions of attention, processing speed, visual learning, and working memory. The CogState Brief Battery is an approximately 15 minute computerized battery with demonstrated reliability, validity, and short term stability, that was developed expressly for maximal sensitivity to detect change. CogState can be administered via the internet or on a stand-alone computer and is available in over 50 languages.

Cognitive Drug Research Assessment System (CDR-AS)

Enrolled participants will be randomized in a balanced manner to CDR-AS in both the Main Study and the SubStudy. CDR-AS is fully automated system that targets the core aspects of cognitive function crucial for everyday behavior which are vulnerable to numerous insults including aging, fatigue, disease, pathology, trauma, diet, and pharmaceuticals. CDR-AS is an approximately 20-minute computerized battery designed to reliably measure changes in cognitive function in clinical trial situations.

Delis Kaplan Executive Function System (DKEFS)

Enrolled participants will be randomized in a balanced manner to DKEFS in the Main Study and at one site of the SubStudy. The DKEFS is a paper and pencil measure of verbal and nonverbal executive functions that has been normed and validated for children and adults from 8-89 years of age. The measure consists of nine subtests. For the purposes of this study, the Trail Making Test (TMT) and Verbal Fluency subtests will be used.

COGNITO

Enrolled participants will be randomized in a balanced manner to COGNITO at the other site of the SubStudy. COGNITO is an approximately 45 to 60 minute computerized neuropsychometric examination based on well-known cognitive tests designed for both cognition research and clinical assessment. COGNITO assesses reaction time, primary and working memory, visuospatial and verbal secondary memory, implicit learning, language skills, functional and semantic categorization of visual data, focused and divided attention, and crystallized intelligence. Responses are made via a tactile screen which permits the recording of response latency (deducting reaction time provides an estimation of information processing time).

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SubStudy includes participants who have completed Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Preclinical Alzheimer Cognitive Composite (PACC) neurocognitive testing at least once during the SubStudy screening visits and have a baseline global Clinical Dementia Rating scale (CDR) score of 0.

You may qualify if:

• Completed Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) and Preclinical Alzheimer Cognitive Composite (PACC) neurocognitive testing at least once during the SubStudy screening visits
• Have a global Clinical Dementia Rating (CDR) score of 0 at screening
• Be fluent in and able to read and write in English; be willing and able to give written informed consent; and have adequate hearing and visual acuity to complete the required psychometric tests
• Be otherwise in satisfactory health and medically stable on the basis of medical history, vital signs, and physical exam. Any abnormalities must not be the cause or be associated with cognitive impairment

You may not qualify if:

• Meets clinical criteria for Alzheimer's disease (AD) dementia, Mild Cognitive Impairment (MCI) diagnosis, or has any degenerative brain disorder that is associated with dementia, such as Parkinson's disease
• Participants whose age- and education-adjusted cognitive performance is more than 1.5 standard deviation (SD) below normal on any of the RBANS Index scores at the first RBANS administration
• Any known history of familial autosomal dominant AD or other familial dementing diseases
• History of or current thyroid disease or thyroid dysfunction, which is currently uncontrolled or untreated, or clinically significant abnormal thyroid function tests. Participants treated for thyroid disease may be enrolled following review of their records of thyroid function, laboratory tests at screening, diagnosis and treatment history by the Investigator or designee
• Any contraindications for magnetic resonance imaging (MRI) (example, pacemaker, metal prostheses, implants, claustrophobia, pacemakers etc) unless MRI compatible

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (2)

Unknown Facility

Edinburgh, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Related Publications (2)

• Taylor S, Dunn L, Udeh-Momoh C, Abbott K, Giannakopoulou P, Middleton L, Robinson O, Kalsi J, Kafetsouli D, Ford J. Technology readiness among UK-based cognitively unaffected older adults during the COVID-19 pandemic: potential implications for decentralised alzheimer's disease prevention trials. BMC Geriatr. 2025 Jul 30;25(1):563. doi: 10.1186/s12877-025-06158-3.

  PMID: 40739178 DERIVED

• Udeh-Momoh CT, Watermeyer T, Price G, de Jager Loots CA, Reglinska-Matveyev N, Ropacki M, Ketter N, Fogle M, Raghavan N, Arrighi M, Brashear R, Di J, Baker S, Giannakopoulou P, Robb C, Bassil D, Cohn M, McLellan-Young H, Crispin J, Lakey K, Lisa C, Chowdary Seemulamoodi Y, Kafetsouli D, Perera D, Car J, Majeed A, Ward H, Ritchie K, Perneczky R, Kivipelto M, Scott D, Bracoud L, Saad Z, Novak G, Ritchie CW, Middleton L. Protocol of the Cognitive Health in Ageing Register: Investigational, Observational and Trial Studies in Dementia Research (CHARIOT): Prospective Readiness cOhort (PRO) SubStudy. BMJ Open. 2021 Jun 24;11(6):e043114. doi: 10.1136/bmjopen-2020-043114.

  PMID: 34168021 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood, saliva, and urine specimens will be collected.

MeSH Terms

Conditions

Alzheimer Disease; Plaque, Amyloid

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2014
• First Posted: April 15, 2014
• Study Start: February 5, 2014
• Primary Completion: June 10, 2024
• Study Completion: July 10, 2024
• Last Updated: April 25, 2025

Record last verified: 2025-04

Locations

GB (2)