Spermidine to improve sleep and memory in mild cognitive impairment
Official title: Autophagy-Enhancers to Reduce Sleep Disturbances: A Combined Approach
Run by University Medicine Greifswald · NCT07383311 · Data updated 2026-11-12
This will see if taking daily spermidine supplements for 12 weeks improves sleep quality and sleep-related memory in older adults with MCI due to Alzheimer's disease.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 55 Years to 75 Years |
| Sex | All |
| Enrollment | 76 (estimated) |
| Sponsor | University Medicine Greifswald Academic / other |
| Locations | 1 site (Greifswald, Mecklenburg-Vorpommern) |
| Status | Recruiting |
| Started | October 28, 2025 |
| Main results expected | December 2028 |
| Study ends | May 2029 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT07383311 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal participants are German-speaking adults aged 55–70 with clinically defined MCI due to Alzheimer's disease who can give informed consent and are not taking polyamine supplements.
✕Probably not a fit
People with dementia, major medical or psychiatric comorbidities, current polyamine supplement use, non-German speakers, or those outside the 55–70 age range are unlikely to receive benefit from participating.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Participants complete an adaptation night and a baseline overnight EEG assessment, then are randomly assigned to receive either 6 mg/day spermidine (three 2 mg sachets) or a placebo for 12 weeks in a double-blind, randomized, placebo-controlled design. After the supplementation period a second overnight EEG is performed to compare sleep architecture and sleep-dependent memory consolidation between groups. A healthy control group of age- and sex-matched volunteers (n=38) undergoes the same baseline assessments without receiving the intervention to provide normative reference data. The trial enrolls German-native speakers aged 55–70 with clinically defined MCI and preserved daily function.
Why it matters
Potential benefit: If successful, spermidine could improve sleep architecture and strengthen memory consolidation during sleep, which might help slow cognitive decline in people with MCI.
How similar studies have gone: Animal studies show memory and neuroprotective effects of spermidine, and small human trials in subjective cognitive decline or MCI have reported preliminary cognitive benefits, but large randomized data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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)
Where it's running
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Department of Neurology, University Medicine Greifswald
Greifswald, Mecklenburg-Vorpommern, Germany Recruiting
Study contacts
- Study coordinator: Agnes Flöel, Prof. Dr.
- Email: agnes.floeel@med.uni-greifswald.de
- Phone: +49 (0)3834 86-6815
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.