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 @ 4:31 AM
Ignite Modification Date:
2025-12-25 @ 4:31 AM
NCT ID:
NCT02289118
Eligibility Criteria:
Inclusion Criteria:
1. Participants will be 45 - 70 years of age
2. MMSE \> 10 at screening visit.
3. Participants must be informed of the investigational nature of this study and provide written informed consent in accordance with institutional and federal guidelines prior to study-specific procedures. If the patient is unable to provide informed consent, the patient's legal representative may consent on behalf of the patient but the patient will be asked to confirm assent.
4. Participants must be willing and able to comply with scheduled visits and imaging procedures.
5. A brain MRI is required. If a brain MRI has been performed within 6 months of enrollment to this study and of adequate quality that scan may be used for the study analysis, subjects who do not have a brain MRI will undergo a brain MRI either as a part of this study
6. Participants must identify a study partner who is willing to accompany the patient to study visits
Exclusion Criteria:
1. Females who are pregnant or breast feeding at the time of screening scan will not be eligible for this study, urine or serum pregnancy test will be performed in women of child-bearing potential at the time of screening
2. Inability to tolerate or contraindication to imaging procedures (PET/CT or MRI) in the opinion of an investigator or treating physician
3. QTc \> 450 msec on screening ECG.
4. Any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study (e.g. moderate to large stroke or history of moderate or severe traumatic brain injury (TBI)).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
70 Years
Study:
NCT02289118
Study Brief:
Protocol Section:
NCT02289118