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Subjective Cognitive Decline (SCD)Phase 2SmartAgeNCT03094546

Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline

A Phase 2 study testing Polyamine in people with Subjective Cognitive Decline (SCD), run by Charite University, Berlin, Germany at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 60 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Subjective Cognitive Decline (SCD)
What is being tested?
Polyamine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteGermany
Study dates
Jan 2017to Oct 2020
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Cognitive healthy individuals with subjective memory decline and self-reported concerns
  • 60-90 years old
  • No manifest dementia (DSM-IV criteria)
  • No limitations in activities of daily living
  • Capacity for consent

Who cannot join

  • Gluten, histamine or wheat seedling intolerance
  • Severe neurological, internal or psychological diseases
  • Advanced heart or respiratory diseases, severe arteriosclerosis, untreated thyroid disease or diabetes
  • Malignant tumors, current or past history
  • Brain tumors, stroke
  • Disorders that impair attention
Show all 10Show fewer
  • Dementia
  • Coagulation disorder, Marcumar
  • Drug abuse or alcohol dependency
  • Current polyamine substitution

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Charité University Medicine Berlin, CCM, Department of Neurology,

    Berlin, 10117

Other trials in Germany

About this study

Official title: Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function and Biomarkers in Elderly Individuals With Subjective Cognitive Decline

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.

Read the detailed description

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).

Being tested
Polyamine, Placebo
Keywords
subjective cognitive decline, Alzheimer's disease, dementia, dietary supplement, polyamine, prevention, treatment, lifestyle, memory, autophagy
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PolyamineDietary supplement

    12 months of polyamine supplementation (6 capsules/day)

  • PlaceboDietary supplement

    12 months of placebo intake (6 capsules/day)

Study groups in NCT03094546
Study groupRoleWhat they receive
Polyamine supplementationExperimentalIntervention: Dietary Supplement (Polyamine supplementation): 750 mg wheat germ extract
Receives: Dietary Supplement: Polyamine
PlaceboPlacebo comparatorIntervention: Dietary Supplement Placebo: 750 mg cellulose
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: change from baseline after 12 month (Prior to intervention (baseline T0) and after 12 months)

Secondary outcomes (6)

  1. 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

    Measured: change from baseline after 12 month

  2. Change in polyamine concentration

    comparing polyamine concentration derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention

    Measured: change from baseline after 12 month

  3. Change in inflammation

    comparing inflammation markers derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention

    Measured: change from baseline after 12 month

  4. Change in Brain imaging biomarkers

    Multimodal analysis of biomarkers, regarding structural, functional, and perfusion-related plasticity, derived from magnet resonance imaging

    Measured: change from baseline after 12 month

  5. Change in Autophagy processes

    Evaluate autophagy processes through muscle biopsy assessed prior to intervention (pre) vs. 12 month post intervention

    Measured: change from baseline after 12 month

  6. Change in Autophagy processes

    Evaluate autophagy processes through blood parameters assessed prior to intervention (pre) vs. 12 month post intervention

    Measured: change from baseline after 12 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Mar 2017
  2. Study startJan 2017
  3. Primary completionMay 2020
  4. Study completionOct 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
100 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03094546
Sponsor's protocol ID
SmartAge
Acronym
SmartAge
Status last verified
Apr 2021
First submitted
14 Mar 2017
Last updated
26 Apr 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 19801973

  • 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.

    PubMed 23995066

  • 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.

    PubMed 23391920

  • 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.

    PubMed 21869457

  • 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.

    PubMed 22689910

  • 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.

    PubMed 19735716

  • 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.

    PubMed 19763038

  • 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.

    PubMed 22467251

  • 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.

    PubMed 35616942

  • 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.

    PubMed 31039826

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Polyamine in people with Subjective Cognitive Decline (SCD), run by Charite University, Berlin, Germany at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Memory performance from neuropsychological test (time frame: change from baseline after 12 month (Prior to intervention (baseline T0) and after 12 months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03094546, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.

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SmartAge Clinical Trial NCT03094546 | AzTrials