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 @ 4:34 AM
Ignite Modification Date:
2025-12-25 @ 4:34 AM
NCT ID:
NCT07249918
Eligibility Criteria:
Inclusion Criteria:
* For participants with dementia:
1. Clinical diagnosis of probable Alzheimer's disease (AD) or mild cognitive impairment (MCI) due to AD, based on established diagnostic criteria.
2. Presence of at least one prominent behavioral or psychological symptom of dementia (BPSD), including depression, agitation, apathy, or nighttime sleep disturbance.
3. Prominent is defined as:
NPI single-item score ≥ 4 (severity × frequency), or NPI-Q severity score ≥ 2, or PSQI total score ≥ 5 (if sleep disturbance is the main symptom).
4. Stable living arrangement or care environment for at least two weeks before enrollment.
5. If receiving any pharmacological or non-pharmacological treatments for BPSD, the dosage and frequency must have remained stable for at least two weeks prior to study participation.
6. Able and willing to provide informed consent; for those lacking decision-making capacity, consent must be obtained from a legally authorized representative.
* For primary caregivers:
1. Adult primary caregiver of the enrolled participant.
2. If receiving treatment for caregiver stress, the dosage and frequency must have been stable for at least two weeks before enrollment.
3. Willing and able to provide informed consent.
Exclusion Criteria:
* Any medical condition that may increase risk during participation, including:
1. Retinal disease, active use of photosensitizing medications, recent ocular surgery (within 4 weeks), or photosensitivity disorders (e.g., epilepsy).
2. Unstable physical or mental condition deemed unsuitable by investigators, such as acute delirium or active respiratory infection (including COVID-19)
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT07249918
Study Brief:
Protocol Section:
NCT07249918