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 @ 10:32 PM
Ignite Modification Date:
2025-12-24 @ 10:32 PM
NCT ID:
NCT04505735
Eligibility Criteria:
Inclusion Criteria:
Patients may be enrolled in the Normal Control group if the following criteria are met:
1. Males or nonpregnant females ≥ 50 years of age;
2. Have no history of memory complaints;
3. Have no diagnosis of MCI or dementia from a physician
4. Currently enrolled in the Rocky Mountain Alzheimer's Disease Center at the University of Colorado School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and Clinical Phenotyping Study (COMIRB #15-1774) or Longitudinal Innate Immunity and Aging study (LIIA; COMIRB #18-2607)
5. Willing to have clinical research information from the Longitudinal Biomarker and Clinical Phenotyping Study (COMIRB #15-1774) and/or LIIA (COMIRB #18-2607) study shared/combined with the current study.
6. Participated in the MRI procedure for COMIRB #15-1774 or COMIRB #18-2607.
Patients may be enrolled in the Mild Cognitive Impairment (not demented) group if the following criteria are met:
1. Males or nonpregnant females ≥ 50 years of age;
2. Have cognitive decline verified by a study partner or cognitive impairment verified by the study physician. The cognitive decline has had limited impact on functional activities; general cognition and functional performance are sufficiently preserved such that a diagnosis of dementia cannot be made by the enrolling physician
3. Have a Clinical Dementia Rating score of 0.5\*
4. Can tolerate a 70-minute PET scan. The Principal Investigator and Co-PI will carefully assess each patient and use sound judgment to determine whether the patient can tolerate the PET scan procedure;
5. Ability to provide informed consent for study procedures (If the patient is ineligible to give informed consent, based on local standards, the patient's legally authorized representative may consent on behalf of the patient but the patient must still confirm assent. This person may serve as the study partner as well).
6. Concurrently enrolled in the Rocky Mountain Alzheimer's Disease Center at the University of Colorado School of Medicine (RMADC at UCSOM) Longitudinal Biomarker and Clinical Phenotyping Study (Bio-AD; COMIRB #15-1774) or Longitudinal Innate Immunity and Aging study (LIIA; COMIRB #18-2607)
7. Participated in the MRI procedure for COMIRB #15-1774 or COMIRB #18-2607.
8. Willing to have clinical research information from the Longitudinal Biomarker and Clinical Phenotyping Study (COMIRB #15-1774) and/or LIIA (COMIRB #18-2607) study shared/combined with the current study.
* For aging adults with atypical phenotypes (e.g., early onset Alzheimer's Disease; Posterior Cortical Atrophy; Logopenic variant primary progressive aphasia), a CDR of 1 will be accepted if the study team determines that their severity is mild. The reason for this caveat is that these phenotypes often reach a CDR of 1 quickly due to cortical symptoms (e.g., loss of visual perception); in these cases, the CDR may overestimate their true severity level.
Exclusion Criteria:
Patients will be excluded from enrollment if they:
1. Have a current serious or unstable illness that in the enrolling physician's opinion, could interfere with completion of the safety or efficacy evaluations included in this study.
2. Have a known brain lesion, pathology or alternative diagnosis that strongly explains the patient's clinical presentation;
3. Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
4. Have had a clinical radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; have had a research radiopharmaceutical imaging study done within 12 months or have one planned in the next 12 months.
5. Exposed to radiation in the work place during the previous year
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT04505735
Study Brief:
Protocol Section:
NCT04505735