Prognostic value of Aβ Imaging in NPH Prior to Shunt Placement
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
- Jacksonville, Florida: 11-004532
NCT ID: NCT01834625
Sponsor Protocol Number: 11-004532
About this study
In this pilot study the investigators shall prospectively in a blinded fashion evaluate with AB PET and CSF AB42 and tTau or pTau in patients committed to shunt surgery and then investigate the relationship of these biomarkers with outcome on gait, cognition and urinary control improvement in the short term (3 months) and long term (1 year). The imaging agent will be provided by AVID.
Furthermore the study will standardize imaging studies using florbetapir F 18 PET to provide information on amyloid burden.
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:
- Age ≥ 60.
- Visual and auditory acuity adequate for neuropsychological testing.
- Completed six grades of education or has a good work history (sufficient to exclude mental retardation).
- Must speak English fluently.
- Willing to undergo one Amyloid imaging PET scan.
- Agrees to at least one lumbar puncture for the collection of CSF.
- Must agree to return for a Month 3 and Month 12 visit.
- Participant, who in the opinion of the investigator, can tolerate the PET scan procedures
Exclusion Criteria:
- History of schizophrenia (DSM IV criteria).
- History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
- Participation in clinical studies involving neuropsychological measures being collected more than one time per year.
- Exclusion for amyloid imaging with 18F -AV-45: Current or recent participation in any procedures involving radioactive agents such that the total radiation dose exposure to the participant in any given year would exceed the limits of annual and total dose commitment set forth in the US Code of Federal Regulations (CFR) Title 21 Section 361.1.
- 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 participant?
-
Current clinically significant cardiovascular disease, including one or more of:
- cardiac surgery or myocardial infarction within the last 4 weeks;
- unstable angina;
- acute decompensated congestive heart failure or class IV heart failure
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 |
|
Jacksonville, Fla.
Mayo Clinic principal investigator Neill Graff-Radford, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available