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

Miranka Wirth; Claudia Schwarz; Gloria Benson; Nora Horn; Ralph Buchert; Catharina Lange; Theresa Köbe; Stefan Hetzer; Marta Maglione; Eva Michael; Stefanie Märschenz; Knut Mai; Ute Kopp; Dietmar Schmitz; Ulrike Grittner; Stephan J. Sigrist; Slaven Stekovic; Frank Madeo; Agnes Flöel

doi:10.1186/s13195-019-0484-1

Alzheimer's Research & Therapy

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
Lifestyle (lifelong)	CAI [89]	On-site interview		x
Personality	BFI-10 [90]	On-site paper		x
Personality	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
Memory	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
Attention	TAP [99] subtests: alertness and divided attention	On-site Computer		x	x
Language	Semantic/Phonemic Fluency [100]	On-site		x	x	x
Language	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
Quality of life	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
Subjective cognitive function	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
Muscle function/strength*	Handgrip strength	On-site		x	x	x

*Only for participants, who consented to muscle biopsy
Abbreviations: Aβ 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

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