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:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-25 @ 4:30 AM
NCT ID:
NCT02082418
Eligibility Criteria:
Inclusion criteria subjects with dementia:
* Dementia diagnosis
* Ability to walk, sit down and stand up independently
* Age 55 years or older
* Ability to lie in supine or elevated position for 8 hours
* Willingness and ability to comply with the protocol, including:
Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit
Inclusion criteria healthy subjects:
* Healthy male or female according to the investigator's or appointed staff's judgment
* Ability to walk, sit down and stand up independently
* Age 55 years or older
* Ability to lie in supine or elevated position for 8 hours
* Willingness and ability to comply with the protocol, including:
Adhering to fasting state from 10 pm ± 2h onwards the day prior to each study visit
Exclusion Criteria:
* Any condition that may interfere with the definition 'healthy subject' according to the investigator's judgment (for healthy control group only)
* Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject to comply with the protocol requirements
* Indication of severe cognitive impairment (MOCA score \< 17)
* Established diagnosis of Insulin Dependent Diabetes Mellitus
* History of untreated metabolic disease(s) including hepatic or renal disorder
* Presence of acute illness or metabolically unstable chronic illness
* Presence of fever within the last 3 days
* Preplanned surgery of procedures that would interfere with the conduct of the study
* Any other condition according to the PI or study physician that would interfere with proper conduct of the study / safety of the patient
* Current alcohol or drug abuse
* Known allergy to milk or milk products
* Use of long-term oral corticosteroids or short course of oral corticosteroids 4 weeks preceding first test day
* Use of protein or amino acid containing nutritional supplements within 5 days of test day
* (Possible) pregnancy
* BMI of \< 18.5 or ≥ 40 kg/m2
* Dietary or lifestyle characteristics: When during the period from enrollment to completion of the study (end of test day) any condition is developed, whether causing the subject to not meet inclusion criteria or to meet exclusion criteria, the subject will be excluded from the study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT02082418
Study Brief:
Protocol Section:
NCT02082418