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 @ 5:04 PM
Ignite Modification Date:
2025-12-24 @ 5:04 PM
NCT ID:
NCT02486250
Eligibility Criteria:
Inclusion Criteria:
* Adults age 60 years and older
* Fluent in English
* Able to give informed consent
* Access and the ability to use the internet
Exclusion Criteria:
* Evidence or diagnosis of dementia
* Evidence of acute or uncontrolled medical illness
* Recent history (\< 6 months) of abuse or dependence of drugs and/or alcohol
* Significant neurological disease (ex. Parkinson's disease, Epilepsy, Traumatic brain injury)
Additionally, subjects participating in the neuroimaging portion of the study, will be excluded for any of the following:
* Unable or unwilling to travel to SFVAMC and UCSF China Basin campuses for MRI and PET procedures
* Contraindications for MR exam, including claustrophobia, paramagnetic metal implants, inability to fit comfortably in MRI (BMI \< 38)
* 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
* 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 \> 450 msec
* History of drug or alcohol abuse within the last year, or prior prolonged history of abuse
* Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception. Women of childbearing potential must not be pregnant or breastfeeding at screening.
* History of relevant severe drug allergy or hypersensitivity.
* Receiving an investigational medication under an FDA IND protocol within the last 30 days. Additionally, the time between the last dose of the previous experimental medication and enrollment (completion of screening assessments) must be at least equal to 5 times the terminal half-life of the previous experimental medication. Subjects who have ever participated in an experimental study with an amyloid targeting therapy (e.g., immunotherapy, secretase inhibitor) may not be enrolled without prior sponsor approval unless it can be demonstrated that the patient received only placebo in the course of the trial.
* Current clinically significant unstable medical comorbidities, as indicated by history that pose a potential safety risk to the subject
* Receiving a radiopharmaceutical for imaging or therapy within the past 24 hours prior to the imaging session for this study
* Opinion of the Investigator that the subject is otherwise an unsuitable for study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
60 Years
Study:
NCT02486250
Study Brief:
Protocol Section:
NCT02486250