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 @ 9:38 PM
Ignite Modification Date:
2025-12-24 @ 9:38 PM
NCT ID:
NCT06049732
Eligibility Criteria:
Inclusion Criteria:
* Subjects enrolled in the study should meet all of the following criteria:
1. have been diagnosed with moderate-to-severe dementia on the basis of the score obtained with one of the following tools:
1. Mini-Mental State Examination (MMSE) score \< 19 OR
2. MDS Cognitive Performance Scale (CPS) score \> 3 OR
3. Another cognitive assessment tool routinely used within the aged care facility allowing the identification of subjects with moderate-to-severe dementia
2. are unable to reliably self-report pain as determined by the caregiver
3. have been living in the aged care home for at least 30 days prior to the day of screening
4. must have had an informed consent signed by the subject's legally authorized representative
Exclusion Criteria:
* Subjects enrolled in the study should not meet any of the following criteria:
1. subject is unable to partially or completely exhibit any facial expression (e.g. as a result of a facial palsy, facial injuries or other pathologies)
2. the treating physician determines it is inappropriate to assess the subject for pain
3. subject is currently receiving or has received in the last 30 days prior to screening an investigational product and/or participated in another clinical trial.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT06049732
Study Brief:
Protocol Section:
NCT06049732