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Table 1 SmartAge study outcome assessment

From: Effects of spermidine supplementation on cognition and biomarkers in older adults with subjective cognitive decline (SmartAge)—study protocol for a randomized controlled trial

Time point Measurement Mode V0 V1 V2 V3
Enrollment       
 Eligibility screening   Telephone x    
 Screening assessment MMSE [85] On-site paper x   x x
Logical Memory [53] On-site paper x   x x
TMT A [54] On-site paper x   x x
GDS [56, 86] On-site paper x   x x
IADL [55] On-site paper x   x x
 Signed informed consent   On-site x    
 Allocation/randomization     x   
Intervention      
Assessments       
 Baseline variables
  Demographic information Age, civil status, education On-site paper   x   
  Family history Dementia, Parkinson disease, and stroke On-site paper   x   
  Subjective cognitive function ECog-39 [87] On-site paper   x   
  Lifestyle (lifelong) LEQ [88] At-home paper   x   
CAI [89] On-site interview   x   
  Personality BFI-10 [90] On-site paper   x   
SVF-78 [91] On-site paper   x   
  Hand preference Oldfield Hand Preference [92] On-site paper   x   
  Premorbid IQ MWT [93] On-site paper   x   
  Genetic markers APOE ε4 status On-site   x   
  Cerebral PET (optional consent) Aβ status On-site   x   
 Primary outcome
  Memory MST [38] On-site Computer   x x x
 Secondary outcomes
  Memory VLMT [94] On-site paper   x x x
Doors and People [95] On-site paper   x x x
  Executive function Digit Symbol [96] On-site paper   x x x
TMT B [54] On-site paper   x x x
Block Tapping [97] On-site paper   x x x
Stroop [98] On-site paper   x x x
  Attention Digit Span [96] On-site paper   x x x
TAP [99] subtests: alertness and divided attention On-site Computer   x x  
  Language Semantic/Phonemic Fluency [100] On-site   x x x
Boston Naming Test [100] On-site paper   x x x
  Lifestyle (current)
   Physical activity FKA [101] At-home paper   x x x
   Cognitive activity CAI Present [89] On-site interview   x x x
   Sleep quality PSQI [102] At-home paper   x x x
   Diet FFQ [33, 63] At-home paper   x x x
MEDAS [103, 104] On-site paper   x x x
FFL [19, 62] At-home paper   x x x
  Psycho-affective/worry PSWQ [105, 106] At-home paper   x x x
RSQ-D [107] On-site paper   x x x
STAI-G [108] On-site paper   x x x
  Quality of life SF-12 [109] On-site paper   x x x
WHOQOL-BREF [110] At-home paper   x x x
  Autophagy markers from muscle biopsy (optional consent) LC3 I/II, p62 [72], EP300 [111], proteomics, metabolomics [73] On-site   x x  
  Blood-based markers Polyamine levels [33], metabolomics, proinflammatory biomarkers, and neurotrophin levels On-site   x x  
  Cerebral neuroimaging markers Brain structure, perfusion, function On-site   x x  
 Exploratory outcomes
  Subjective cognitive function ECog-39, adapted [87] On-site paper   x x x
MMQ, adapted [112] On-site paper   x x x
  Cardiovascular risk factors Blood pressure, lipid profile, glucose metabolism On-site   x x x
  Muscle function/strength* SPPB [113] On-site   x x x
Handgrip strength On-site   x x x
  1. *Only for participants, who consented to muscle biopsy
  2. Abbreviations: β-amyloid, APOE apolipoprotein E, BFI-10 Big Five Inventory-10, CAI Cognitive Activity Interview, ECog Everyday Cognition Scales, FKA Freiburger Fragebogen zur körperlichen Aktivität, FFL food frequency list, FFQ Food Frequency Questionnaire, GDS Geriatric Depression Scale, IADL Instrumental Activities of Daily Living Scale, LEQ Lifetime Experience Questionnaire, MEDAS Mediterranean Diet Adherence Screener, MMQ Meta Memory Questionnaire, MMSE Mini-Mental State Examination, MST Mnemonic Similarity Task, MWT Mehrfachwahl-Wortschatztest, PET positron emission tomography, PSQI Pittsburgh Sleep Quality Index, PSWQ Penn State Worry Questionnaire, RSQ-D Response Styles Questionnaire—Deutsche Version, SF-12 Short Form Health Survey, SPPB Short Physical Performance Battery, STAI-G State-Trait Anxiety Inventory, SVF-78 Stressverarbeitungsfragebogen, TAP Testbatterie zur Aufmerksamkeitsprüfung, TMT Trail Making Test, VLMT Verbaler Lern-und Merkfähigkeitstest, WHOQOL-BREF World Health Organization Quality of Life