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Completed

NCT Number: NCT03094546

Polyamine-enriched Diet 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.

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Key information

Conditions

Subjective Cognitive Decline (SCD) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Charité University Medicine Berlin, CCM, Department of Neurology,

Berlin, 10117, Germany

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Polyamine

Dietary Supplement

12 months of polyamine supplementation (6 capsules/day)

Placebo

Dietary Supplement

12 months of placebo intake (6 capsules/day)

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • Freie Universität Berlin
  • Karl-Franzens-Universität, Institute of Molecular Biosciences, Graz, Austria

Registry information

Official study title

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

Acronym: SmartAge

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Mar 29, 2017
Registry last updated
Apr 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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