Clinical trial NCT03094546: Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline
Official title: Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function and Biomarkers in Elderly Individuals With Subjective Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Subjective Cognitive Decline (SCD)
Keywords: subjective cognitive decline
Alzheimer's disease, dementia
dietary supplement
polyamine
prevention
treatment
lifestyle
memory
autophagy
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
Collaborators: name: Freie Universität, Institute of Biology/Genetic, Berlin, Germany
name: Karl-Franzens-Universität, Institute of Molecular Biosciences, Graz, Austria
First posted: 2017-03-29
Enrollment: 100
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: Change in Memory performance from neuropsychological test
timeFrame: change from baseline after 12 month (Prior to intervention (baseline T0) and after 12 months)
Secondary outcomes:
measure: Change in Cognitive Function (from extended neuropsychological test battery)
timeFrame: change from baseline after 12 month
measure: Change in polyamine concentration
timeFrame: change from baseline after 12 month
measure: Change in inflammation
timeFrame: change from baseline after 12 month
measure: Change in Brain imaging biomarkers
timeFrame: change from baseline after 12 month
measure: Change in Autophagy processes
timeFrame: change from baseline after 12 month
measure: Change in Autophagy processes
timeFrame: change from baseline after 12 month
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité University Medicine Berlin, CCM, Department of Neurology,
Study officials:
affiliation: Charité - Universitätsmedizin Berlin, Greifswald Universitätsmedizin
name: Agnes Floeel, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Charite University, Berlin, Germany
name: Dietmar Schmitz, Prof
role: PRINCIPAL_INVESTIGATOR
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