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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT05159869
Eligibility Criteria:
Inclusion Criteria:
Persons with dementia must:
* Be English-speaking
* Have a diagnosis of early-stage dementia based on standard assessments and diagnostic criteria \[e.g., Diagnostic and Statistical Manual of Mental Disorders 5 (DSM-5)\]
* Be medically stable and responsive to the environment (e.g., not comatose). If participants with dementia are on any of four classes of psychotropic medications (antidepressant, benzodiazepines, antipsychotic, or anti-convulsant) or an anti-dementia medication (memantine or a cholinesterase inhibitor), the investigators will require that participants have been on a stable dose for 60 days prior to enrollment (typical time frame in clinical trials) to minimize possible confounding effects of concomitant medications.
Exclusion Criteria:
* Dementia in the moderate or severe stages
* Bed-boundedness, defined as confined to bed or chair for at least 22 hours a day for at least four of the previous seven days
* Are receiving palliative care or are at end-of-life
* A diagnosis of schizophrenia or a bipolar disorder
* Dementia secondary to probable head trauma
* The participant is taking any neuroleptic medications or has any of the following medical diagnosis: (a) restless legs syndrome, (b) delirium, or (c) akathisia, medication-induced, or other movement disorders such as Parkinson's disease or essential tremor.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT05159869
Study Brief:
Protocol Section:
NCT05159869