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 @ 1:21 PM
Ignite Modification Date:
2025-12-24 @ 1:21 PM
NCT ID:
NCT03328195
Eligibility Criteria:
Inclusion Criteria:
* Age is greater than or equal to 50 years old
* Meets the criteria for probable Alzheimer's disease of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
* If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on a stable dosage for at least the prior 3 months
* Mini Mental State Examination (MMSE) score between 0-20 at screening assessment
* Severe Impairment Battery score at baseline of ≤90
* Outpatient with a reliable caregiver willing to commit to study visits and procedures
Exclusion Criteria:
* Current psychiatric or other neurologic disease
* Any history of stroke, seizures, light sensitivity (polymorphous light eruption, solar urticaria, persistent light reactivity) or Lyme disease, including those taking photosensitizing medication
* Currently undergoing light therapy treatment
* Increased skin sensitivity at the treatment site including active herpes simplex in the treatment area, history of keloid formation, or history of retinoid use in the past month
* Pregnant or lactating or planning to become pregnant
* Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments
* Does not speak English at a level necessary for the completion of the assessments.
* Currently participating in another clinical research study involving an investigational product.
* Has participated in a drug or device study within the last 30 days.
* Any condition, such as agitation/aggression, that in the opinion of the investigator would cause the patient to be unable to comply with study procedures
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03328195
Study Brief:
Protocol Section:
NCT03328195