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 @ 12:22 AM
Ignite Modification Date:
2025-12-25 @ 12:22 AM
NCT ID:
NCT02161458
Eligibility Criteria:
Inclusion Criteria:
* 1\) Age 60-85 (inclusive), male and female, any race.
* 2\) Capacity to give informed consent and follow study procedures.
* 3\) English speaking.
* 4\) MOCA = 23 or greater
Exclusion Criteria:
* 1\) Known history of relevant severe drug allergy or hypersensitivity (e.g. to Citalopram or Escitalopram)
* 2\) Does not speak English
* 3\) Cannot give informed consent
* 4\) Diagnosis of Major Depression
* 5\) Previous history of neurological disorders, such as Parkinson's disease, Alzheimer's disease or traumatic brain injury, cognitive impairment or dementia.
* 6\) Diagnosis of a chronic psychiatric illness
* 7\) Significant hearing or visual impairment
* 8\) Bleeding diathesis
* 9\) Clinically significant hepatic, renal, pulmonary, metabolic or endocrine disturbances as indicated by history, which in the opinion of the investigator might pose a potential safety risk to the subject.
* 10\) Current clinically significant cardiovascular disease. Clinically significant cardiovascular disease usually includes one or more of the following: cardiac surgery or myocardial infarction within the last 4 weeks; unstable angina; acute decompensated congestive heart failure or class IV heart failure; current significant cardiac arrhythmia or conduction disturbance, particularly those resulting in ventricular fibrillation, or causing syncope or near syncope; uncontrolled high blood pressure; QTc greater than 450msec (by history for subjects with cardiac disease); documented prior stroke.
* 11\) Clinically significant abnormalities on EKG. Primary AV block or Right bundle branch block are not necessarily exclusionary.
* 12\) History of drug or alcohol abuse within the last year or prior prolonged history of abuse
* 13\) Use of an Investigational medicine within the past 30 days 14) Use of Coumadin, Warfarin or other blood thinners within the past 6 months
* 15\) Use of antipsychotic medication or antidepressant medication (e.g. MAOIs, SSRIs, SNRIs).
* 16\) Use of the following drug/drug classes: Pimozide, Triptans, Tricyclics, Lithium, Tramadol
* 17\) Use of over-the-counter supplements such as tryptophan or St. Johns Wort 18) Any other factor that in the investigator's judgment may affect patient safety or compliance (e.g. distance greater than 100 miles from the research institution)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
85 Years
Study:
NCT02161458
Study Brief:
Protocol Section:
NCT02161458