Bridging Study of C11 PiB and F18 Flutemetamol Brain PET
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 12-000118
NCT ID: NCT01607476
Sponsor Protocol Number: 12-000118
About this study
The intent of this research protocol is to test the equivalency of two amyloid imaging drugs (C11 Pittsburgh Compound B and F18 Flutemetamol). The investigators hypothesize that there will be no significant difference in the distribution of the agents to areas of amyloid deposition in the brain or to other normal brain structures. Recent data have shown similarity in the distribution of the drugs in subjects with AD or mild cognitive impairment (MCI). No comparison data of the two PET drugs in normal subjects has been published. It is important to understand differences in the images and biodistribution from the two drugs in normal subjects as nonspecific accumulation of the drugs in brain structures such as white matter appear to differ slightly and could affect image performance.
The current clinical functional imaging standard for patients with indeterminate cognitive impairment is FDG PET. To allow a comparison of the PET amyloid imaging compounds with FDG PET, FDG PET scans will also be important to acquire in the subjects for comparison.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Males or females 30 years of age or older.
- Subjects who have the clinical diagnosis of probable AD (30) ages 50 and older who have a study partner who is the participant's power of attorney (POA) or legally authorized representative (LAR), cognitive normal elderly (30) age >60 and cognitive normal young subjects (30) ages 30-60.
- Normal subjects with Clinical Dementia Rating (CDR) 0-0.5 and AD subjects with CDR of 0.5 or greater.
Exclusion Criteria:
- Subjects unable to lie down without moving for 30 minutes.
- Women who are pregnant or who cannot stop breast feeding for 24 hours.
- Standard safety exclusionary criteria for MRI such as metallic foreign bodies, pacemaker, etc,.
- Subjects who are too claustrophobic to perform the tests.
- Subject who have had previous brain irradiation, stroke or brain tumor(s)
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator Val Lowe, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available