- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01834625
Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
-
Jacksonville, Florida, United States, 32224
- Mayo Clinic
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Florbetapir +ve NPH patients
Florbetapir +ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months
|
|
Florbetapir -ve patients
Florbetapir -ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Baseline to 1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Neill R Graff-Radford, MD, Mayo Clinic
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-004532
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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