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Autophagy-Enhancers to Reduce Sleep Disturbances

RecruitingNAAges 55 Years - 75 YearsAllUniversity Medicine Greifswald
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In plain words

What the trial is, and whether it could suit you

This clinical trial investigates the effects of spermidine supplementation on sleep quality and sleep-dependent memory consolidation in older adults with Subjective Cognitive Decline (SCD) or Mild Cognitive Impairment (MCI), two populations at increased risk of future cognitive decline and dementia. 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 i

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria (SCD participants): * Men and women * Written consent to participate in the study * German at native speaker level * Age between 55 and 75 years * Subjective Cognitive Decline operationalized as: 1. Subjectively reported decline in cognitive function (particularly memory) despite objectively normal cognitive performance (e.g., WMS-LM) 2. Preservation of functional independence 3. No dementia Inclusion Criteria (MCI patients): * Men and women * Written consent to participate in the study * German at native speaker level * Age between 55 and 75 years * Mild cognitive impairment (MCI) operationalized as: 1. A change in cognitive abilities reported by the patient, relatives or clinic staff (i.e. historical or observed evidence of deterioration over time) 2. Objective evidence of memory impairment (at least 1.0 Standard Deviation (SD) below the normal range on the Wechsler Logical Memory Scale (WMS-LM)); other cognitive domains may also be affected (i.e. amnestic MCI and amnestic + MCI) 3. Preservation of independence of functional abilities 4. No dementia Exclusion Criteria (SCD and MCI participants): * Patients who are unable to give informed consent * Polyamine intake via dietary supplements and/or participation in corresponding intervention studies * Dementia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) * Any condition that impairs clinical or neuropsychological examination procedures * Diabetes mellitus * Polycystic ovary syndrome * Signs of epilepsy, focal brain lesion or head injury with loss of consciousness or immediate post-injury confusion * Previous stroke * Severe untreated medical problems or unstable medical condition * Current major depressive episode * Psychotic disorder * Bipolar disorder * Current or previous substance abuse * Other neurodegenerative disease, e.g. Parkinson's disease * Vascular dementia * Alcohol abuse * Participation in an interventional study in the last 3 months and during the entire study period * Sleep disorders * Taking medication that primarily affects the central nervous system (e.g. antipsychotics, antidepressants, benzodiazepines or any type of over-the-counter sleep-inducing medication such as valerian; anti-dementia medication) * Known intolerances or allergies to wheat germ, gluten or histamine Inclusion criteria (healthy controls): * Men and women * Written consent to participate in the study * German at native speaker level * Age between 55 and 75 years * Subjective cognitive disorders are denied Exclusion criteria (healthy controls): * Subjects who are not able to give informed consent * Polyamine intake via dietary supplements and/or participation in corresponding intervention studies * Dementia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) * Mild cognitive impairment (MCI), defined as described above in the patient inclusion criteria * Any condition that interferes with clinical or neuropsychological examination procedures * Diabetes mellitus * Polycystic ovary syndrome * Signs of epilepsy, focal brain lesion or head injury with loss of consciousness or immediate post-injury confusion * Previous stroke * Severe untreated medical problems or unstable medical condition * Current major depressive episode * Psychotic disorder * Bipolar disorder * Current or past substance abuse * Other neurodegenerative disease, e.g. Parkinson's disease * Vascular dementia * Alcohol abuse * Participation in an interventional study in the last 3 months and during the entire study period * Sleep disorders * Taking medication that primarily affects the central nervous system (e.g. antipsychotics, antidepressants, benzodiazepines or any type of over-the-counter sleep-inducing medication such as valerian; anti-dementia medication)
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What it tests

  • Spermidine Supplementation
  • Dietary Placebo
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Where

1 site
Department of Neurology, University Medicine Greifswald
Greifswald, Germany
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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