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 @ 3:18 AM
Ignite Modification Date:
2025-12-25 @ 3:18 AM
NCT ID:
NCT02580305
Eligibility Criteria:
Inclusion Criteria:
* Has a diagnosis of probable Alzheimer's disease based on the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria at least 1 year prior to the screening visit.
* Has a score between 12 and 20 inclusive on the MMSE at the screening and baseline visits.
* Has a MRI or CT scan performed within 12 months prior to screening with findings consistent with the diagnosis of dementia due to Alzheimer's disease without any other clinically significant comorbid pathologies.
* Must be receiving treatment with stable doses of donepezil HCl and memantine HCl for at least 3 months prior to the screening visit
* Availability of an eligible and reliable caregiver
* Must be living in the community or an assisted living facility.
* Must be ambulatory or ambulatory aided (use of cane or walker).
* Is not pregnant or planning to become pregnant during the study.
* Subject (or subject's legally acceptable representative) and caregiver must sign an Informed Consent to participate in the study.
Exclusion Criteria:
* Has a diagnosis of dementia due to other than Alzheimer's Disease
* Is taking cholinesterase inhibitors other than donepezil HCl or taking doses of donepezil HCl other than 10 mg
* Is taking doses of memantine HCl other than 10 mg bid or Namenda XR® 28 mg qd.
* Has uncontrolled cardiac disease or hypertension.
* Has clinically significant renal or hepatic impairment.
* Has cancer or a malignant tumor, untreated thyroid disorder or has a history of seizure disorder
* Is treated or likely to require treatment during the study, with any medications prohibited by the study protocol.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
85 Years
Study:
NCT02580305
Study Brief:
Protocol Section:
NCT02580305