NCT01834625TerminatedNot Applicable
Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Mayo Clinic
- Enrollment
- 2
- Locations
- 1
- Primary Endpoint
- Comparison of change between florbetapir +ve and -ve patients from baseline to one year in the Montreal Cognitive Assessment (MoCA)
Study Overview
Brief Summary
In this pilot study the investigators shall prospectively in a blinded fashion evaluate with Aβ PET 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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 60 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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
Outcomes
Primary Outcomes
Comparison of change between florbetapir +ve and -ve patients from baseline to one year in the Montreal Cognitive Assessment (MoCA)
Time Frame: Baseline to 1 year
Secondary Outcomes
No secondary outcomes reported
Investigators
Neill R. Graff-Radford, M.D.
Professor of Neurology
Mayo Clinic
Study Sites (1)
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