Autophagy-Enhancers to Reduce Sleep Disturbances

NCT ID
NCT07383311
Registry status
Recruiting
Study type
Interventional
Phase
Not applicable
Sponsor
University Medicine Greifswald
Conditions
Mild Cognitive Impairment Due to Alzheimer's Disease, Subjective Cognitive Decline (SCD)

Overview

ClinicalTrials.gov lists this study as Recruiting.

Official title: Autophagy-Enhancers to Reduce Sleep Disturbances: A Combined Approach

Enrollment: 76 participants (Estimated).

What is being studied

  • Dietary supplement: Dietary Placebo
  • Dietary supplement: Spermidine Supplementation

Who may be eligible

Ages
55 Years to 75 Years
Sex
All
Healthy volunteers accepted
Yes

ClinicalTrials.gov lists the following eligibility 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)

Study locations

1 study location is listed.

Recruiting site status is explicitly provided for 1 location; 1 is listed as Recruiting.

Countries: Germany

  • Mecklenburg-Vorpommern, Germany: 1

Sample of listed locations

  • Department of Neurology, University Medicine Greifswald — Greifswald, Mecklenburg-Vorpommern, 17475, Germany — Recruiting

Study details

Start date
October 28, 2025
Primary completion date
December 1, 2028
Completion date
May 1, 2029
First posted
February 3, 2026
Collaborators
Department of Experimental Neuroimmunology, University Medicine, Institute for Clinical Chemistry and Laboratory Medicine, University Medicine Greifswald, Institute of Biology, Department of Biology, Chemistry, Pharmacy, Freie Universität Berlin

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07383311
Registry last updated
October 2, 2026
QualifiedStudies registry data refreshed
October 12, 2026
QualifiedStudies record fetched
October 12, 2026

View NCT07383311 on ClinicalTrials.gov

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