Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT05387057
Eligibility Criteria:
INCLUSION CRITERIA:
Participants fulfilling all of the following inclusion criteria are eligible for the study:
* (1 = mNCD) clinical diagnosis of 'Mild Neurocognitive Disorder' according to the International Classification of Diseases 11th Revision (ICD-XI) or the Diagnostic and statistical manual of mental disorders (DSM-5®)) OR (2 = sMCI) patients screened for mild cognitive impairment (sMCI) according to the following criteria: (a) informant (i.e. healthcare professionals)-based suspicion of MCI confirmed by (b) an objective screening of MCI based on the German Version of the Quick Mild Cognitive Impairment Screen with (b1) a recommended cut-off score for cognitive impairment (MCI or dementia) of \< 62/100 (doi: 10.3233/JAD-161204), while (b2) not falling below the cut-off score for dementia (i.e. \< 45/100 (doi: 10.3233/JAD-161204)).
* German speaking
* able to stand at least for 10 min without assistance
EXCLUSION CRITERIA:
The presence of any of the following exclusion criteria will lead to exclusion of the participants:
* mobility impairments (i.e. gait, balance) that prevent experiment participation
* presence of additional, clinically relevant (i.e. acute and/or symptomatic) neurological disorders (i.e. epilepsy, stroke, multiple sclerosis, Parkinson's disease, brain tumors, or traumatic disorders of the nervous system)
* presence of any other unstable or uncontrolled diseases
Additional exclusion criteria will comprise of Covid-19 specific exclusion criteria (according to the Federal Office of Public Health). In case of Covid-19 specific exclusion criteria, participation in the study will only be allowed in case the treating physician provided written informed consent to allow participation in this study despite the presence of Covid-19 specific exclusion criteria. These Covid-19 specific exclusion criteria will include:
* high blood pressure (self-reported; systolic ≥ 140 mmHg and/or Diastolic ≥ 90 mmHg)
* Chronic respiratory condition
* uncontrolled type 2 Diabetes
* Condition or therapy that weakens the immune system
* unstable Cardiovascular Disease
* Cancer (present and/or under treatment)
* Serious obesity (BMI ≥ 40 kg/m2)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT05387057
Study Brief:
Protocol Section:
NCT05387057