Subjective Cognitive Decline (SCD)
Conditions
Keywords
subjective cognitive decline, Alzheimer's disease, dementia, dietary supplement, polyamine, prevention, treatment, lifestyle, memory, autophagy
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).
Interventions
DIETARY_SUPPLEMENTPolyamine
12 months of polyamine supplementation (6 capsules/day)
DIETARY_SUPPLEMENTPlacebo
12 months of placebo intake (6 capsules/day)
Sponsors
Freie Universität, Institute of Biology/Genetic, Berlin, Germany
Karl-Franzens-Universität, Institute of Molecular Biosciences, Graz, Austria
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 90 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Memory performance from neuropsychological test | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Cognitive Function (from extended neuropsychological test battery) | 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 |
| Change in polyamine concentration | change from baseline after 12 month | comparing polyamine concentration derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention |
| Change in inflammation | change from baseline after 12 month | comparing inflammation markers derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention |
| Change in Brain imaging biomarkers | change from baseline after 12 month | Multimodal analysis of biomarkers, regarding structural, functional, and perfusion-related plasticity, derived from magnet resonance imaging |
| Change in Autophagy processes | change from baseline after 12 month | Evaluate autophagy processes through muscle biopsy assessed prior to intervention (pre) vs. 12 month post intervention |
Countries
Germany
Outcome results
None listed