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| Name | Class |
|---|---|
| Freie Universität Berlin | OTHER |
| Karl-Franzens-Universität, Institute of Molecular Biosciences, Graz, Austria | UNKNOWN |
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The overall objective of this study is to examine the effect of polyamine supplementation on cognitive performance and further characterization of individuals with subjective cognitive decline.
Memory abilities are known to decline during aging, a process that is accelerated in pathological conditions like mild cognitive impairment (MCI) and Alzheimer's disease (AD), all of which are a growing public-health concern with devastating social and economical effects. Polyamines supplementation and corresponding up-regulation of autophagy (i.e., cellular protein degradation pathways) may be a key target of intervention against age-related memory decline. The study will investigate whether a polyamine-enriched dietary supplementation (through capsule intake) could provide positive effects on cognitive function and biomarkers of elderly individuals (60-90 years old) with subjective cognitive decline (SCD).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Polyamine supplementation | Experimental | Intervention: Dietary Supplement (Polyamine supplementation): 750 mg wheat germ extract |
|
| Placebo | Placebo Comparator | Intervention: Dietary Supplement Placebo: 750 mg cellulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Polyamine | Dietary Supplement | 12 months of polyamine supplementation (6 capsules/day) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Memory performance from neuropsychological test | Comparing memory function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention | change from baseline after 12 month (Prior to intervention (baseline T0) and after 12 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cognitive Function (from extended neuropsychological test battery) | Comparing cognitive function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention | change from baseline after 12 month |
| Change in polyamine concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Agnes Floeel, Prof | Charité - Universitätsmedizin Berlin, Greifswald Universitätsmedizin | Principal Investigator |
| Dietmar Schmitz, Prof | Charite University, Berlin, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité University Medicine Berlin, CCM, Department of Neurology, | Berlin | 10117 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19801973 | Background | Eisenberg T, Knauer H, Schauer A, Buttner S, Ruckenstuhl C, Carmona-Gutierrez D, Ring J, Schroeder S, Magnes C, Antonacci L, Fussi H, Deszcz L, Hartl R, Schraml E, Criollo A, Megalou E, Weiskopf D, Laun P, Heeren G, Breitenbach M, Grubeck-Loebenstein B, Herker E, Fahrenkrog B, Frohlich KU, Sinner F, Tavernarakis N, Minois N, Kroemer G, Madeo F. Induction of autophagy by spermidine promotes longevity. Nat Cell Biol. 2009 Nov;11(11):1305-14. doi: 10.1038/ncb1975. Epub 2009 Oct 4. | |
| 23995066 |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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| ID | Term |
|---|---|
| D011073 | Polyamines |
| ID | Term |
|---|---|
| D000588 | Amines |
| D009930 | Organic Chemicals |
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| Placebo | Dietary Supplement | 12 months of placebo intake (6 capsules/day) |
|
comparing polyamine concentration derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention |
| change from baseline after 12 month |
| Change in inflammation | comparing inflammation markers derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention | change from baseline after 12 month |
| Change in Brain imaging biomarkers | Multimodal analysis of biomarkers, regarding structural, functional, and perfusion-related plasticity, derived from magnet resonance imaging | change from baseline after 12 month |
| Change in Autophagy processes | Evaluate autophagy processes through muscle biopsy assessed prior to intervention (pre) vs. 12 month post intervention | change from baseline after 12 month |
| Change in Autophagy processes | Evaluate autophagy processes through blood parameters assessed prior to intervention (pre) vs. 12 month post intervention | change from baseline after 12 month |
| Background |
| Gupta VK, Scheunemann L, Eisenberg T, Mertel S, Bhukel A, Koemans TS, Kramer JM, Liu KS, Schroeder S, Stunnenberg HG, Sinner F, Magnes C, Pieber TR, Dipt S, Fiala A, Schenck A, Schwaerzel M, Madeo F, Sigrist SJ. Restoring polyamines protects from age-induced memory impairment in an autophagy-dependent manner. Nat Neurosci. 2013 Oct;16(10):1453-60. doi: 10.1038/nn.3512. Epub 2013 Sep 1. |
| 23391920 | Background | Ibe S, Kumada K, Yoshida K, Otobe K. Natto (fermented soybean) extract extends the adult lifespan of Caenorhabditis elegans. Biosci Biotechnol Biochem. 2013;77(2):392-4. doi: 10.1271/bbb.120726. Epub 2013 Feb 7. |
| 21869457 | Background | Minois N, Carmona-Gutierrez D, Madeo F. Polyamines in aging and disease. Aging (Albany NY). 2011 Aug;3(8):716-32. doi: 10.18632/aging.100361. |
| 22689910 | Background | Schaeffer V, Lavenir I, Ozcelik S, Tolnay M, Winkler DT, Goedert M. Stimulation of autophagy reduces neurodegeneration in a mouse model of human tauopathy. Brain. 2012 Jul;135(Pt 7):2169-77. doi: 10.1093/brain/aws143. Epub 2012 Jun 10. |
| 19735716 | Background | Soda K, Dobashi Y, Kano Y, Tsujinaka S, Konishi F. Polyamine-rich food decreases age-associated pathology and mortality in aged mice. Exp Gerontol. 2009 Nov;44(11):727-32. doi: 10.1016/j.exger.2009.08.013. Epub 2009 Sep 6. |
| 19763038 | Background | Soda K, Kano Y, Sakuragi M, Takao K, Lefor A, Konishi F. Long-term oral polyamine intake increases blood polyamine concentrations. J Nutr Sci Vitaminol (Tokyo). 2009 Aug;55(4):361-6. doi: 10.3177/jnsv.55.361. |
| 22467251 | Background | Tiboldi A, Lentini A, Provenzano B, Tabolacci C, Hoger H, Beninati S, Lubec G. Hippocampal polyamine levels and transglutaminase activity are paralleling spatial memory retrieval in the C57BL/6J mouse. Hippocampus. 2012 May;22(5):1068-74. doi: 10.1002/hipo.22016. Epub 2012 Mar 30. |
| 35616942 | Derived | Schwarz C, Benson GS, Horn N, Wurdack K, Grittner U, Schilling R, Marschenz S, Kobe T, Hofer SJ, Magnes C, Stekovic S, Eisenberg T, Sigrist SJ, Schmitz D, Wirth M, Madeo F, Floel A. Effects of Spermidine Supplementation on Cognition and Biomarkers in Older Adults With Subjective Cognitive Decline: A Randomized Clinical Trial. JAMA Netw Open. 2022 May 2;5(5):e2213875. doi: 10.1001/jamanetworkopen.2022.13875. |
| 31039826 | Derived | Wirth M, Schwarz C, Benson G, Horn N, Buchert R, Lange C, Kobe T, Hetzer S, Maglione M, Michael E, Marschenz S, Mai K, Kopp U, Schmitz D, Grittner U, Sigrist SJ, Stekovic S, Madeo F, Floel A. Effects of spermidine supplementation on cognition and biomarkers in older adults with subjective cognitive decline (SmartAge)-study protocol for a randomized controlled trial. Alzheimers Res Ther. 2019 May 1;11(1):36. doi: 10.1186/s13195-019-0484-1. |
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |