TABLE A2.
List of primary endpoints used in phase III‐type trials, as grouped by domain classification
| Domain classification |
|---|
| Cognitive only |
| AKT (Alters‐Konzentrations‐Test) |
| Alzheimer's Disease Cooperative Study ‐ Preclinical Alzheimer Cognitive Composite (ADCS‐PACC) |
| Alzheimer's Prevention Initiative Composite Cognitive (APCC) Test Score |
| Alzheimer's Disease Assessment Scale–Cognitive Subscale (ADAS‐Cog) |
| Brief Praxis Test |
| Buschke Selective Reminding Test |
| Cambridge Examination for Mental Disorders in the Elderly–Cognitive Section (CAMCOG) |
| Category/Letter Fluency |
| Change on a composite score of immediate and delayed recall of verbal and visual memory |
| Choice Reaction Time (CRT) |
| Clock Drawing Test |
| Composite Score of a Broad Cognitive Test Battery |
| Composite Z Score (combining 4 different cognitive tests including 10 Mini‐Mental State Examination [MMSE] questions) |
| Consortium to Establish a Registry for Alzheimer's Disease–Neuropsychological (CERAD‐NP) |
| Delayed Recall Test |
| Dementia Rating Scale |
| DemTect |
| Free and Cued Selective Reminding Test |
| Global Deterioration Scale |
| Gruber & Buscke Test |
| Hasegawa's Dementia Scale‐Revised (HDS‐R) |
| Mini‐Mental State Examination |
| National Institute of Neurological Disorders and Stroke (NINDS)‐initiated EXecutive Abilities: Measures and Instruments for Neurobehavioral Evaluation and Research or (EXAMINER) Tool Box |
| Neurospsychological Test Battery |
| New York University (NYU) Paragraph Delayed Recall Test |
| Preclinical Alzheimer's Cognitive Composite‐5 (PACC‐5) |
| Rey Auditory Verbal Learning Test |
| Seoul Neuropsychologic Screening Battery |
| Seven Minute Test |
| Severe Impairment Battery |
| Stroop Interference Condition ‐ Completion Time and Errors |
| Syndrom Kurz Test (SKT) |
| Trail Making Test |
| Vascular Dementia Assessment Scale ‐ Cognitive Subscale (VaDAS‐cog) |
| Verbal Learning Task Scores |
| Visual Continuous Performance Test (CPT) |
| Wechsler Memory Scale‐Revised Logical Memory (WMS‐R LM) for Immediate and Delayed Recall |
| Behavioral only |
| Alzheimer's Disease Assessment Scale (ADAS) ‐ Behavioral Subscale |
| Apathy Evaluation Scale (AES) |
| Assessment of the Clinical Significance of Behavioral Change Rated by the Study Clinician |
| Behavioral Pathology in Alzheimer's Disease (BEHAVE‐AD) |
| Brief Psychiatric Rating Scale |
| Cohen‐Mansfield Agitation Inventory (CMAI) |
| Columbia Suicide Severity Rating Scale (C‐SSRS) |
| Cornell Scale for Depression in Dementia |
| Emotional Lability Scale |
| Frontal Systems Behavior Scale |
| Geriatric Depression Scale |
| Global Assessment of Functioning (GAF) |
| Hamilton Depression Scale |
| Italian “Scala per la valutazione del benessere emotivo dell'anziano (SVEBA)” |
| NeuroBehavioral Rating Scale‐ Agitation (NBRS‐A) |
| Neuropsychiatric Inventory (NPI) |
| Pittsburgh Agitation Scale |
| Positive and Negative Syndrome Scale (PANSS) |
| Profile of Mood States (POMS) |
| Relapse (Hallucintions, Delusions from Dementia‐Related Psychosis) |
| Sandoz Clinical Assessment‐Geriatric |
| Sheehan Suicidality Tracking Scale (S‐STS) Score |
| Social Dysfunction and Aggression Scale ‐ 9 (SDAS‐9) |
| Functional only |
| Activities of Daily Living (ADL) |
| Alzheimer's Disease Cooperative Study–Activities of Daily Living (ADCS‐ADL) |
| Alzheimer's Disease Cooperative Study–Instrumental Activities of Daily Living (ADCS‐IADL) |
| Barthel Index |
| Bristol Activities of Daily Living Scale (BrADL) |
| Caregiver Activity Survey |
| Dependence Scale |
| Disability Assessment for Dementia (DAD) |
| Functional Assessment Staging Tool (FAST) |
| Gait Speed |
| Instrumental Activities of Daily Living (IADL) |
| Minimum Data Set Activities of Daily Living Test (MDS‐ADL) |
| Nuremberg Gerontopsychological Rating Scale for Activities of Daily Living (NAI‐NAA) |
| Physical Self‐Maintenance Scale (PSMS) |
| Timed Up and Go (TUG) Test Score |
| PROs only |
| Abbey Pain Scale |
| Caregiver Stress Scale |
| Epworth Sleepiness Scale (ESS) Score |
| Goal Attainment Scaling (GAS) Score |
| Intensity Rating Scale |
| Mean Total Sleep Time |
| Nighttime Total Sleep Time |
| Pain Assessment Checklist for Seniors with Limited Ability to Communicate (PACSLAC) |
| Pain Assessment in Advanced Dementia (PAINAD) |
| Progressive Deterioration Scale |
| Quality of Life–Alzheimer's Disease (QoL‐AD) |
| Screen for Caregiver Burden |
| Short‐Form Health Survey (SF‐36) |
| Visual Analog Scale |
| Biomarkers only |
| Amyloid PET scan |
| APOE4 |
| Brain Volume Change (as measured by Magnetic Resonance Imaging [MRI]) |
| Cerebrospinal Fluid (CSF) |
| Ferric Reducing Ability of Plasma |
| PMN (Polymorphonuclear Leukocytes) Production |
| Glutathione |
| Interleuken‐1‐Beta |
| Interleukin‐6 |
| Magnetic Resonance Imaging (MRI) |
| Malondialdehyde |
| Modified Hachinski Ischemia Score |
| Oxygenated Hemoglobin Concentration |
| Positron Emission Tomography |
| Regional cerebral blood flow using arterial spin‐labeling Magnetic Resonance Imaging (MRI) |
| Serum Brain‐Derived Neurotrophic Factor (BDNF) Levels |
| Serum Levels of Malondialdehyde |
| Superoxid Dismutase |
| TNF‐Alpha |
| Total Antioxidant Capacity |
| Weight change in kilograms |
| Multi‐domain |
| Alzheimer's Disease Assessment Scale (ADAS) Total |
| Alzheimer's Disease Rating Scale* |
| Alzheimer's Disease Cooperative Study – Clinical Global Impression (ADCS‐CGI)* |
| Blessed‐Roth Scale |
| Clinical Dementia Rating – Sum of Boxes (CDR‐SB)* |
| Clinical Dementia Rating (CDR)* |
| Clinical Global Impression of Change (CGIC)* |
| Clinician's Interview‐Based Impression of Change–Plus Caregiver Input (CIBIC+)* |
| Clinician's Interview‐Based Impression of Change (CIBIC)* |
| Global Improvement Scale (GIS)* |
| Gottfries‐Brane‐Steen Scale* |
| Incidence of Alzheimer's Disease (AD) (based on NICDS [National Institute For Communicable Diseases], ADRD [Alzheimer's Disease and Related Dementias], and DSM‐IV [Diagnostic and Statistical Manual of Mental Disorders] Criteria)* |
| mADCS‐CGI* |
| Nuremberg Activities Inventory* |
| Patient Diary |
| Polysomnography |
| Time to clinical diagnosis of AD by NINCDS‐ADRDA (National Institute of Neurological and Communicative Disorders and Stroke ‐ Alzheimer's Disease and Related Disorders Association) and DSM‐IV Criteria* |
| Time to diagnosis of Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or dementia due to AD* |
Note: *Cognitive/functional composite endpoints which measure cognition/function ± behavior.