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

Primary Purpose

Subjective Cognitive Decline (SCD)

Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
Polyamine
Placebo
Sponsored by
Charite University, Berlin, Germany
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Subjective Cognitive Decline (SCD) focused on measuring subjective cognitive decline, Alzheimer's disease, dementia, dietary supplement, polyamine, prevention, treatment, lifestyle, memory, autophagy

Eligibility Criteria

60 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Polyamine supplementation

Placebo

Arm Description

Intervention: Dietary Supplement (Polyamine supplementation): 750 mg wheat germ extract

Intervention: Dietary Supplement Placebo: 750 mg cellulose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Change in polyamine concentration
comparing polyamine concentration derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention
Change in inflammation
comparing inflammation markers derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention
Change in Brain imaging biomarkers
Multimodal analysis of biomarkers, regarding structural, functional, and perfusion-related plasticity, derived from magnet resonance imaging
Change in Autophagy processes
Evaluate autophagy processes through muscle biopsy assessed prior to intervention (pre) vs. 12 month post intervention
Change in Autophagy processes
Evaluate autophagy processes through blood parameters assessed prior to intervention (pre) vs. 12 month post intervention

Full Information

First Posted
March 14, 2017
Last Updated
April 22, 2021
Sponsor
Charite University, Berlin, Germany
Collaborators
Freie Universität, Institute of Biology/Genetic, Berlin, Germany, Karl-Franzens-Universität, Institute of Molecular Biosciences, Graz, Austria
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1. Study Identification

Unique Protocol Identification Number
NCT03094546
Brief Title
Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline
Acronym
SmartAge
Official Title
Effect of Polyamine-enriched Dietary Supplementation on Cognitive Function and Biomarkers in Elderly Individuals With Subjective Cognitive Decline
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
May 2020 (Actual)
Study Completion Date
October 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
Collaborators
Freie Universität, Institute of Biology/Genetic, Berlin, Germany, Karl-Franzens-Universität, Institute of Molecular Biosciences, Graz, Austria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Cognitive Decline (SCD)
Keywords
subjective cognitive decline, Alzheimer's disease, dementia, dietary supplement, polyamine, prevention, treatment, lifestyle, memory, autophagy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Polyamine supplementation
Arm Type
Experimental
Arm Description
Intervention: Dietary Supplement (Polyamine supplementation): 750 mg wheat germ extract
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Intervention: Dietary Supplement Placebo: 750 mg cellulose
Intervention Type
Dietary Supplement
Intervention Name(s)
Polyamine
Intervention Description
12 months of polyamine supplementation (6 capsules/day)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
12 months of placebo intake (6 capsules/day)
Primary Outcome Measure Information:
Title
Change in Memory performance from neuropsychological test
Description
Comparing memory function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention
Time Frame
change from baseline after 12 month (Prior to intervention (baseline T0) and after 12 months)
Secondary Outcome Measure Information:
Title
Change in Cognitive Function (from extended neuropsychological test battery)
Description
Comparing cognitive function in subjects with polyamine intake and placebo treatment assessed prior to intervention (pre) vs. 12 month post intervention
Time Frame
change from baseline after 12 month
Title
Change in polyamine concentration
Description
comparing polyamine concentration derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention
Time Frame
change from baseline after 12 month
Title
Change in inflammation
Description
comparing inflammation markers derived from blood plasma assessed prior to intervention (pre) vs. 12 month post intervention
Time Frame
change from baseline after 12 month
Title
Change in Brain imaging biomarkers
Description
Multimodal analysis of biomarkers, regarding structural, functional, and perfusion-related plasticity, derived from magnet resonance imaging
Time Frame
change from baseline after 12 month
Title
Change in Autophagy processes
Description
Evaluate autophagy processes through muscle biopsy assessed prior to intervention (pre) vs. 12 month post intervention
Time Frame
change from baseline after 12 month
Title
Change in Autophagy processes
Description
Evaluate autophagy processes through blood parameters assessed prior to intervention (pre) vs. 12 month post intervention
Time Frame
change from baseline after 12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Agnes Floeel, Prof
Organizational Affiliation
Charité - Universitätsmedizin Berlin, Greifswald Universitätsmedizin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dietmar Schmitz, Prof
Organizational Affiliation
Charite University, Berlin, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Charité University Medicine Berlin, CCM, Department of Neurology,
City
Berlin
ZIP/Postal Code
10117
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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19801973
Citation
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Links:
URL
https://neurocure.de/klinisches-zentrum/forschung-am-ncrc/ncrc-investigator/ehemahlige-ncrc-arbeitsgruppen.html
Description
working group is related to healthy aging, cognitive impairments in aging and neurological rehabilitation after stroke

Learn more about this trial

Polyamine-enriched Diet in Elderly Individuals With Subjective Cognitive Decline

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