Outcome measure | Operationalization/type of instrument | B | T3 | T12 | T24 |
---|---|---|---|---|---|
Clinical data | |||||
Demographic data | History taking | P | P | P | |
Cognitive impairment | Mini-mental State Examination | P | P | P | |
Dementia severity | Clinical Dementia Rating | P | P | P | |
Functional disability | Disability Assessment for Dementia | P | P | P | |
Neurological and physical examination | Neurological assessment and evaluation of co-morbidities | P | P | P | |
Neuropsychiatric problems | Neuropsychiatric Inventory | P | P | P | |
Depression | Geriatric Depression Scale 15 | P | P | P | |
Cerebral atrophy and white matter lesions | Structural MRI (T1-weighted, T2-weighted and FLAIR) | P | |||
Neuropsychological Assessment | Rey’s Verbal Learning Test, Visual Association Test, Digit-Span, Letter Digit Substitution Test, Stroop Color-Word Test, Trail Making Test | P | P | P | |
Quality of life data | |||||
Patient generic quality of life | EQ-5D | I*/P | I* | I*/P | I*/P |
Patient disease specific quality of life* | QoL-AD | I * | I * | I * | I * |
Caregiver generic quality of life* | EQ-5D | I | I | I | I |
Caregiver disease specific quality of life* | QoL-AD | I | I | I | I |
Caregiver burden* | Sense Of Competence | I | I | I | I |
Care-related quality of life* | Carer Quality of Life | I | I | I | I |
Cost data* | |||||
Resource utilization and caregiver time | RUD-Lite | I | I | I | I |
Work productivity and absence | Productivity and Disease Questionnaire | I | I | I | I |
Consequences of informal caregiving on paid or unpaid work | Health and Labour Questionnaire | I | I | I | I |
Other resource use | I | I | I | I | |
Emerging biomarker data | |||||
Functional connectivity | Resting state functional MRI | P | |||
White matter integrity | Diffusion tensor imaging | P | |||
Hippocampal volume | Structural MRI | P | |||
Glucose metabolism | Fluorodeoxyglucose PET† | P | |||
Amyloid plaque deposition | Pittsburgh compound B PET†, CSF Aβ1-42 | P | |||
Tau | CSF total tau, CSF phosphorylated tau | P |