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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