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 @ 11:50 PM
Ignite Modification Date:
2025-12-24 @ 11:50 PM
NCT ID:
NCT06725251
Eligibility Criteria:
Inclusion criteria for patients include:
* A diagnosis of Alzheimer's disease, based on the NIA/AA Diagnostic Guidelines for Alzheimer's Disease (McKhann et al., 2011)
* MMSE of 18-26, inclusive, administered within 6 month prior to screening or at screening
* Awareness of diagnosis and/or memory impairment, as determined by semi-structured interview with clinician (see Appendix B)
* Availability and willingness to participate in all 4 sessions of the intervention
* A care partner with whom the patient has regular weekly contact and who is available and willing to participate in all 4 sessions of the intervention
* Sufficient visual acuity to read 12-point font
* Sufficient manual dexterity to use scissors
* Ability to hear instructions in a classroom setting
* Ability to read English
* Age 18 years old or greater
Exclusion criteria for patients include:
* Any uncontrolled medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause of the subject's cognitive impairment (e.g., substance abuse, vitamin B12 deficiency, abnormal thyroid function, stroke or other cerebrovascular condition, Lewy body dementia, fronto-temporal dementia, head trauma).
* Current active psychiatric illness (e.g., major depression, schizophrenia, etc.)
* Current active seizure disorder.
* Malignancy or carcinoma currently requiring active treatment or progressing off of treatment.
* Recent history (within 1 year) of alcohol abuse or drug abuse.
* Active tobacco use that interferes with visits (e.g., if the patient would need to smoke during the therapy session).
* Use of medications (e.g., narcotics, sedatives, etc.) that lead to drowsiness during the therapy sessions
* Inability to comply with the instructions of the art therapist.
* Other unspecified reasons that, in the opinion of the Investigator make the subject unsuitable for enrollment.
* Prisoners
Inclusion criteria for care partners include:
* Adult 18 years of age or older
* Ability to consent
* Regular weekly contact with the subject diagnosed with Alzheimer's disease
* Availability and willingness to participate in all 4 sessions of the intervention
* Sufficient visual acuity to read 12-point font
* Sufficient manual dexterity to use scissors
* Ability to hear instructions in a classroom setting
* Ability to read English
Exclusion criteria for care partners include:
* Any uncontrolled medical or neurological/neurodegenerative condition sufficient to cause cognitive impairment
* Current active psychiatric illness (e.g., major depression, schizophrenia, etc.)
* Current active seizure disorder.
* Malignancy or carcinoma currently requiring active treatment or progressing off of treatment.
* Recent history (within 1 year) of alcohol abuse or drug abuse.
* Active tobacco use that interferes with visits (e.g., if the care partner would need to smoke during the therapy session).
Use of medications (e.g., narcotics, sedatives, etc.) that lead to drowsiness during the therapy sessions
* Inability to comply with the instructions of the art therapist.
* Other unspecified reasons that, in the opinion of the Investigator make the care partner unsuitable for enrollment.
* Prisoners
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06725251
Study Brief:
Protocol Section:
NCT06725251