Table 1.
Cognitive outcome | Description | Assessment schedule |
Secondary outcomes | ||
National Adult Reading Test (NART)29 | The NART is a word reading and pronunciation task comprising 50 English words with irregular grapheme-phoneme and stress rules. It is used to provide an estimate of premorbid intellectual functioning. Average administration time: 10 min. | BL |
Neuropsychological Assessment Battery (NAB) Executive Function module (PAR)30 | The executive function module comprises subtasks that examine planning, impulse control and psychomotor speed (through pen and paper mazes trials of increasing difficulty); judgement and decisional capacity (through questions pertaining to home safety, health and medical issues); concept formation, cognitive flexibility and response set (through a classification and categorisation task) and fluency and generativity (through a word fluency task). Average administration time: 30 min. | M12, M24, M36 |
Neuropsychological Assessment Battery (NAB)—Memory module (PAR) | The memory module comprises explicit learning, free recall, delayed recall and/or delayed recognition subtasks across verbal (list learning; story learning; medication instructions and name and address) and visual (shape learning) information. Average administration time: 45 min. | M12, M24, M36 |
NEUROTRACK (Neurotrack Technologies)31 | Neurotrack is a declarative memory test based on digital eye tracking, administered on an IPAD. The task is a recognition memory test, relying on an individual’s innate preference for novelty. In a familiarisation phase, participants are presented with two identical images, side by side on the computer screen. This is followed by a test phase, in which a familiar image presented during the familiarisation phase and a novel image are shown together. The ratio of time an individual gazes at the novel stimulus relative to the total viewing time constitutes a novelty preference score, with higher scores indicating superior declarative memory function and lower scores indicating impaired function. Average administration time: 10 min. | M3, M9, M15, M21, M27, M33, M39 |
Randomised tasks | ||
Cognitive Drug Research Assessment System (CDRAS) (Bracket; United BioSource Corporation)32 | The CDRAS measures three domains of cognition: Attention (simple and choice reaction time, digit vigilance); Working memory (articulatory and spatial working memory); Episodic secondary memory (word recall, word recognition and picture recognition). Average administration time: 20 min. | M3, M9, M15, M21, M27, M33, M39 |
Cogstate (Cogstate)20 | CogState consists of 4 tasks involving the presentation of playing cards. These tasks measure the functions of attention, processing speed, visual learning, and working memory using standard psychometric paradigms (ie, simple and choice reaction time, n-back and pattern separation learning). For the first assessment visit, M3, the task is administrated twice within one session to control for task familiarity and practice effects. Average administration time: 15 min. | M3, M9, M15, M21, M27, M33, M39 |
Delis-Kaplan Executive Function System (Pearson)33 ICL Site Only |
The DKEFS is a paper and pencil measure of verbal and nonverbal executive functions and comprises nine subtests. For this study, the Trail Making Test (visual attention and task switching) and Verbal Fluency (fluency and generativity) subtests are used. Total average administration time to complete these two subtests:15 min. | M3, M9, M15, M21, M27, M33, M39 |
Cognito34 EDI Site Only |
COGNITO is a computerised task which assesses reaction time, primary and working memory (an articulation subtest further permitting identification of problems related to the articulatory loop), visuospatial and verbal secondary memory (with free, cued and multiple choice paradigms), implicit learning (priming), language skills (word and syntax comprehension, naming, verbal fluency), functional and semantic categorization of visual data (visual reasoning and form perception), focused and divided attention (visual and auditory modalities), and crystallised intelligence (vocabulary). Responses are made via a tactile screen which permits the recording of response latency (deducting reaction time provides an estimation of information processing time). Qualitative aspects of performance (perseveration, intrusions, visual field neglect) are also recorded. Administration time varies between 45 to 60 min, depending on level of impairment. | M3, M9, M15, M21, M27, M33, M39 |
Functional outcomes | Description | Assessment schedule |
Clinical Dementia Rating Scale35 | The CDR is used as a clinical staging instrument and is administered to both participant and study partner, using a semistructured format. It assesses six domains: memory; orientation; judgement and problem solving; involvement in community affairs; home and hobbies; and personal care. Average administration time: 15–20 min with the study partner and 10–15 min with the participant, depending on the severity of cognitive impairment. | M12, M24, M36 |
Cognitive Function Index36 | The CFI is a modified version of the Mail-in Cognitive Function Screening Instrument (MCFSI, Walsh et al, 2006) a self-reported and informant-reported subjective outcome measure regarding activities of daily living. It includes 14 questions that assess participants’ perceived ability to perform high level tasks in daily life and their sense of overall cognitive functional ability, indicating whether or not there has been a change in performance (yes/no/maybe) compared with 1 year ago. Study participants and their study partners independently rate the participant’s level of ability. Average administration time: 10 min. | M12, M24, M36 |
Alzheimer’s disease Cooperative Study ADL prevention instrument (ADCS-ADL-PI)37 | The ADCS-ADL-PI includes 15 subjectively rated questions related to activities of daily living and 5 questions related to physical functioning. Study participants and their study partners independently rate the study participant’s level of ability. Partners are additionally asked to evaluate whether activities were completed less often, required more time to complete, and if errors were made performing the task. Physical functioning items are rated as yes or no. Average administration time: 10 min. | M12, M24, M36 |
BL, Baseline.