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New treatment option for Mild Cognitive Impairment Due to Alzheimer's Disease
Official title Autophagy-Enhancers to Reduce Sleep Disturbances
ClinicalTrials.gov ID: NCT07383311
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 70. Healthy volunteers may be eligible.
You may be able to join if
- (SCD participants):
- Men and women
- Written consent to participate in the study
- German at native speaker level
- Age between 55 and 70 years
You likely can't join if
- (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
See the full eligibility 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:
- Subjectively reported decline in cognitive function (particularly memory) despite objectively normal cognitive performance (e.g., WMS-LM)
- Preservation of functional independence
- No dementia (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:
- A change in cognitive abilities reported by the patient, relatives or clinic staff (i.e. historical or observed evidence of deterioration over time)
- 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...
- Preservation of independence of functional abilities
- No dementia
- (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 treatment 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...
- 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):
- people 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 treatment 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...
The study team makes the final eligibility decision.
Where it's taking place
- Greifswald, Mecklenburg-Vorpommern, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 70 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Greifswald, Mecklenburg-Vorpommern, Germany. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.