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 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 12:02 AM
NCT ID:
NCT01922258
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects 55 to 90 years of age, inclusive, at the time of informed consent.
* Subjects who are residing at their current location for at least 14 days before screening and are expected to remain at the same location for the duration of the trial.
* Subjects with diagnosis of probable Alzheimer's disease according to NINCDS-ADRDA criteria.
* Subjects with a MMSE score of 5 to 22, inclusive, at screening and baseline visits.
* Subjects with onset of symptoms of agitation at least 2 weeks prior to the screening visit.
* Subjects with a total score greater than or equal to 4 on the agitation aggression item of the NPI-NH or NPI/NPI-NH at the screening and baseline visits.
* Subjects who require pharmacotherapy for the treatment of agitation per the investigator's judgement, after an evaluation of reversible factors (eg, pain, infection, polypharmacy) and a trial of nonpharmacological interventions.
* Subjects must have a previous MRI or CT scan of the brain, which was performed after the onset of symptoms of dementia, with findings consistent with the diagnosis of Alzheimer's disease.
Exclusion Criteria:
* Subjects with dementia or other memory impairment not due to Alzheimer's disease.
* Subjects with history of stroke, well-documented transient ischemic attack, or pulmonary or cerebral embolism.
* Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, gastrointestinal, or psychiatric disorders.
* Subjects who have been diagnosed with an Axis I disorder (DSM-IV-TR criteria).
* Subjects with uncontrolled hypertension.
* Subjects with uncontrolled insulin-dependent diabetes mellitus (IDDM)
* Subjects with epilepsy or a history of seizures.
* Subjects considered in poor general health based on the investigator's judgment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Maximum Age:
90 Years
Study:
NCT01922258
Study Brief:
Protocol Section:
NCT01922258