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Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline (SmartAge)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03094546
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : March 30, 2017
Sponsor:
Collaborators:
Freie Universität, Institute of Biology/Genetic, Berlin, Germany
Karl-Fransens-Universität, Institute of Molecular Biosciences, Graz, Austria
Information provided by (Responsible Party):
Agnes Flöel, Charite University, Berlin, Germany

Brief 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.

Condition or disease Intervention/treatment Phase
Subjective Cognitive Decline (SCD) Dietary Supplement: Polyamine Dietary Supplement: Placebo Phase 2

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function and Biomarkers in Elderly Individuals With Subjective Cognitive Decline
Actual Study Start Date : January 2017
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Polyamine supplementation
Intervention: Dietary Supplement (Polyamine supplementation):
Dietary Supplement: Polyamine
12 months of polyamine supplementation (6 capsules/day)

Placebo Comparator: Placebo
Intervention: Dietary Supplement Placebo:
Dietary Supplement: Placebo
12 months of placebo intake (6 capsules/day)




Primary Outcome Measures :
  1. Change in Memory performance from neuropsychological test [ Time Frame: change from baseline after 12 month (Prior to intervention (baseline T0) and after 12 months) ]
    Comparing memory function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention


Secondary Outcome Measures :
  1. Change in Cognitive Function (from extended neuropsychological test battery) [ Time Frame: change from baseline after 12 month ]
    Comparing cognitive function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention

  2. Change in polyamine concentration [ Time Frame: change from baseline after 12 month ]
    comparing polyamine concentration derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention

  3. Change in inflammation [ Time Frame: change from baseline after 12 month ]
    comparing inflammation markers derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention

  4. Change in Brain imaging biomarkers [ Time Frame: change from baseline after 12 month ]
    Multimodal analysis of biomarkers, regarding structural, functional, and perfusion-related plasticity, derived from magnet resonance imaging

  5. Change in Autophagy processes [ Time Frame: change from baseline after 12 month ]
    Evaluate autophagy processes through muscle biopsy assessed prior to intervention (pre) vs. 12 month post intervention

  6. Change in Autophagy processes [ Time Frame: change from baseline after 12 month ]
    Evaluate autophagy processes through blood parameters assessed prior to intervention (pre) vs. 12 month post intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • Dementia
  • Coagulation disorder, Marcumar
  • Drug abuse or alcohol dependency
  • Current polyamine substitution

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03094546


Contacts
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Contact: Gloria Benson, Graduate +49 30/450 660 223 gloria.benson@charite.de
Contact: Miranka Wirth, Graduate +49 30/ 450 560 185 miranka.wirth@charite.de

Locations
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Germany
Charité University Medicine Berlin, CCM, Department of Neurology, Recruiting
Berlin, Germany, 10117
Contact: Gloria Benson, Graduate       gloria.benson@charite.de   
Contact: Claudia Schwarz, Graduate       claudia.schwarz@charite.de   
Sponsors and Collaborators
Charite University, Berlin, Germany
Freie Universität, Institute of Biology/Genetic, Berlin, Germany
Karl-Fransens-Universität, Institute of Molecular Biosciences, Graz, Austria
Investigators
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Principal Investigator: Agnes Floeel, Prof Charité - Universitätsmedizin Berlin, Greifswald Universitätsmedizin
Principal Investigator: Dietmar Schmitz, Prof Charite University, Berlin, Germany

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Agnes Flöel, Prof. Agnes Flöel, MD;, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT03094546    
Other Study ID Numbers: SmartAge
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: March 30, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Agnes Flöel, Charite University, Berlin, Germany:
subjective cognitive decline
Alzheimer's disease, dementia
dietary supplement
polyamine
prevention
treatment
lifestyle
memory
autophagy
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders