Sleep aid from wheat germ? spermidine trial targets memory decline
NCT ID NCT07383311
First seen Jun 27, 2026 · Last updated Jul 02, 2026 · Updated 1 time
Summary
This study tests whether spermidine, a natural substance found in foods like wheat germ, can improve sleep quality and memory in older adults with mild cognitive impairment (MCI), a condition that raises dementia risk. 76 participants aged 55-70 will take spermidine or a placebo daily for 12 weeks. Researchers will measure brain activity during sleep and test memory before and after treatment to see if spermidine helps protect cognitive function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 76 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2025
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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55 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria (SCD participants): * Men and women * Written consent to participate in the study * German at native speaker level * Age between 55 and 70 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 70 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 70 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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Department of Neurology, University Medicine Greifswald
RECRUITINGGreifswald, Mecklenburg-Vorpommern, 17475, Germany
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Other studies related to the condition(s) this trial covers.
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