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 @ 4:26 AM
Ignite Modification Date:
2025-12-25 @ 4:26 AM
NCT ID:
NCT05227820
Eligibility Criteria:
In order for a subject to be considered for this study, the following criterion is required:
Inclusion Criteria:
* Cognitive decline with Clinical Dementia Rating (CDR) score of 0.5 to 1, suggesting mild cognitive impairment to mild dementia.
* Participants must be between the ages of 50-89
* Primary cognitive complaint must be memory Impairment without movement or psychiatric explanation/diagnosis
* Participants must show at least one abnormal imaging biomarker and none of the exclusion criteria below.
Exclusion Criteria:
In order for a subject to be considered for this study, he/she may NOT have any of the following:
* Subjects with contraindications for lumbar puncture, such as bleeding abnormalities, use of anticoagulant medications, and local skin or spine abnormalities
* Reversible causes of cognitive impairment that explains the clinical status entirely, such as hypothyroidism, depression
* Advanced stages of any terminal illness or any active cancer that requires chemotherapy
* History of breast cancer
* Women with child-bearing potential who are not willing to use a double-barrier birth control method
* Males not willing to use a double-barrier birth control method with female sex partners with child-bearing potential
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
89 Years
Study:
NCT05227820
Study Brief:
Protocol Section:
NCT05227820