Actively Recruiting

Phase Not Applicable
Age: 55Years - 70Years
All Genders
Healthy Volunteers
NCT07383311

Autophagy-Enhancers to Reduce Sleep Disturbances

Led by University Medicine Greifswald · Updated on 2026-02-03

76

Participants Needed

1

Research Sites

183 weeks

Total Duration

On this page

Sponsors

U

University Medicine Greifswald

Lead Sponsor

D

Department of Experimental Neuroimmunology, University Medicine

Collaborating Sponsor

AI-Summary

What this Trial Is About

This clinical trial investigates the effects of spermidine supplementation on sleep quality and memory function in older adults with Mild Cognitive Impairment (MCI), a condition associated with an increased risk of developing dementia, particularly in patients with MCI due to Alzheimer's disease. Impaired sleep has been identified as a modifiable factor contributing to cognitive decline, and interventions targeting sleep architecture could offer therapeutic potential to prevent or slow down this decline. Spermidine is a naturally occurring polyamine found in foods such as wheat germ and soybeans. It induces autophagy, a cellular degradation and recycling process essential for neuronal maintenance and function. In animal studies, spermidine has been shown to improve memory performance, reduce neuroinflammation, and support mitochondrial health. Preliminary findings from human trials in individuals with subjective cognitive decline or MCI suggest potential cognitive benefits of spermidine, but results are not unequivocal, and the impact on sleep has not been systematically evaluated. In this randomized, double-blind, placebo-controlled trial, 76 participants aged 55 to 70 years with MCI will receive either spermidine (6 mg/day) or a placebo for 12 weeks. Sleep will be evaluated using overnight EEG in a controlled laboratory setting, focusing on measures such as slow-wave sleep and sleep spindle activity. Memory performance will be assessed before and after the intervention using standardized neuropsychological testing. Numerical skills will be tested at baseline only to compare MCI patients with healthy controls. Blood samples will be collected to quantify metabolic indicators, neurodegeneration-related biomarkers, and autophagy-associated proteins. A control group of 38 cognitively healthy individuals will undergo comparable sleep and cognitive assessments without receiving any supplementation. The primary objective of the study is to characterize the impact of spermidine on sleep-dependent memory consolidation and to identify associated biological changes relevant to aging and neurodegeneration. The results may inform the development of non-pharmacological strategies aimed at preserving cognitive function in individuals at risk for dementia.

CONDITIONS

Official Title

Autophagy-Enhancers to Reduce Sleep Disturbances

Who Can Participate

Age: 55Years - 70Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women
  • Written consent to participate in the study
  • German at native speaker level
  • Age between 55 and 70 years
  • Mild cognitive impairment (MCI) with reported cognitive decline
  • Objective memory impairment at least 1.0 standard deviation below normal on the Wechsler Logical Memory Scale
  • Preservation of independence in daily functioning
  • No diagnosis of dementia
Not Eligible

You will not qualify if you...

  • Unable to give informed consent
  • Intake of polyamine supplements or participation in related intervention studies
  • Diagnosis of dementia based on DSM-IV
  • Any condition impairing clinical or neuropsychological testing
  • Diabetes mellitus
  • Polycystic ovary syndrome
  • Epilepsy, focal brain lesions, or head injury with loss of consciousness or confusion
  • Previous stroke
  • Severe untreated or unstable medical conditions
  • Current major depressive episode
  • Psychotic disorder
  • Bipolar disorder
  • Current or past substance abuse
  • Other neurodegenerative diseases such as Parkinson's disease
  • Vascular dementia
  • Alcohol abuse
  • Participation in another interventional study within last 3 months or during this study
  • Sleep disorders
  • Use of medications primarily affecting the central nervous system including antipsychotics, antidepressants, benzodiazepines, or over-the-counter sleep-inducing drugs like valerian
  • Known allergies or intolerances to wheat germ, gluten, or histamine

AI-Screening

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Trial Site Locations

Total: 1 location

1

Department of Neurology, University Medicine Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany, 17475

Actively Recruiting

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Research Team

A

Agnes Flöel, Prof. Dr.

CONTACT

S

Silke M Wortha, Dr.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

3

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