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 @ 5:54 PM
Ignite Modification Date:
2025-12-24 @ 5:54 PM
NCT ID:
NCT06508268
Eligibility Criteria:
Inclusion Criteria:
A subject with MCI with a likelihood of underlying AD pathophysiology must meet the following criteria:
* Established diagnosis of MCI due to AD with a likelihood according to NIA-AA criteria (Albert et al., 2011).
* A score of stage three on the Global Deterioration Scale (GDS) (Reisberg et al., 1982).
A subject with AD must meet the following criteria:
* Established diagnosis of AD (amnestic or non-amnestic) or etiologically mixed presentation of AD according to DSM-5 (American Psychiatric Association, 2013) or NINCDS-ARDRA criteria (Jack et al., 2018; McKann et al., 2011).
* The following scores on the Global Deterioration Scale (GDS): four for mild AD, five for moderate AD (Reisberg et al., 1982).
All subjects of the control group must meet the following criteria:
* A score of stage one or two on the Global Deterioration Scale (GDS) (Reisberg et al., 1982).
* They are age-matched with the MCI due to AD or AD patients included in the study.
All subjects must meet the following criteria:
* First language is Dutch and/or Frisian.
* Able to walk independently with or without walking aid.
* Able to squeeze with each hand.
Exclusion Criteria:
A subject with MCI due to AD or AD who meets the following criteria will be excluded from participation in this study:
* Having a neurological or neurodegenerative disease or disorder that may be contributing to cognitive impairment above and beyond that caused by AD or mixed AD; Down's syndrome, other subtypes of dementia, autism spectrum disorder.
* Having an established diagnosis of a psychiatric disorder, e.g. schizophrenia, depression.
All subjects in the control group who meets following criteria will be excluded from participation in this study:
● Suffers from a neurological, neurodegenerative or psychiatric disease or disorder.
All subjects in any group who meet any of the following criteria will be excluded from participation in this study:
* Hearing loss (with or without hearing aid) that affects communication.
* Vision loss (with or without glasses or lenses) that affects communication.
* History of language problems, speech problems or dyslexia.
* Suffers from additional disorders or diseases which may limit gait, hand grip strength, language and/or speech.
* Medication use that influence gait, hand grip strength, speech or language performance at time of testing.
* Being terminally ill (i.e., life expectancy \< 2 weeks according to the attending physician).
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT06508268
Study Brief:
Protocol Section:
NCT06508268