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 @ 2:30 AM
Ignite Modification Date:
2025-12-25 @ 2:30 AM
NCT ID:
NCT02769234
Eligibility Criteria:
Inclusion criteria:
Between 60 and 95 years old (inclusive) A diagnosis of Alzheimer's disease A successful ERP/EEG test performed with the COGNISION™ system 2-5 years prior to testing for the current study
A sub-group of up to 40 subjects will be called back to the sites for follow-up ERP/qEEG and psychometric testing. Additional inclusion criteria for these subjects will be:
* Willing and able to undergo ERP/EEG and psychometric testing
* Have a study partner able to provide an independent evaluation of functioning
* Permitted medications stable for at least 2 weeks prior to testing
Exclusion Criteria:
Subjects will not be called back to sites for follow-up testing if they have:
* Known allergy to latex
* Neuropsychological tests administered within three months of study enrollment
* Investigational agents administered within three months of study enrollment
* Severe cognitive and functional deficits that in the judgement of the site PI will prevent them from successfully completing ERP/EEG and/or psychometric testing
* Any significant systemic illness or unstable medical condition at the time of testing which could lead to difficulty complying with the protocol
* Use of psychoactive substances (Gingko Biloba, melatonin, sedatives etc.) will be allowed as long as the subject suspends their use on the day of testing. Smokers will not be required to abstain.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
95 Years
Study:
NCT02769234
Study Brief:
Protocol Section:
NCT02769234