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 @ 12:53 PM
Ignite Modification Date:
2025-12-24 @ 12:53 PM
NCT ID:
NCT05159661
Eligibility Criteria:
Inclusion Criteria:
* Male and female aged between 60 and 75 years
* MCI diagnosis with a MMSE \>= 25
* or MCI diagnosis with MoCa \>= 17
Exclusion Criteria:
* Confirmed dementia
* History of cerebrovascular disease (i.e. stroke episodes)
* Alcohol Use Disorder Identification Test (AUDIT) score positive
* Severe medical disorders associated with cognitive impairment (organ insufficiencies, chronic infections, endocrinological disorders)
* Severe head trauma with structural brain lesion and/or previous brain surgery;
* Severe mental disorders; Schizophrenia, known Major depression or bipolar disorder
* Neuroimaging evidence of other potential causes of cognitive decline (e.g. subdural haematoma, malignancy)
* History of malignancy \< 5 years;
* Recent use of psychotropic drugs including AChEI and Memantine (\< 3 months);
* Participation in trials with experimental drugs.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
75 Years
Study:
NCT05159661
Study Brief:
Protocol Section:
NCT05159661