Status:
TERMINATED
Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement
Lead Sponsor:
Mayo Clinic
Conditions:
Normal Pressure Hydrocephalus Patients
Eligibility:
All Genders
60+ years
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2017
Estimated Enrollment :
2 Patients enrolled
Trial Details
Trial ID
NCT01834625
Start Date
April 1 2013
End Date
October 1 2017
Last Update
February 1 2022
Active Locations (1)
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1
Mayo Clinic
Jacksonville, Florida, United States, 32224