Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement



Status:Terminated
Conditions:Women's Studies
Therapuetic Areas:Reproductive
Healthy:No
Age Range:60 - Any
Updated:2/10/2018
Start Date:April 2013
End Date:October 2017

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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.


Inclusion Criteria:

1. Age ≥ 60.

2. Visual and auditory acuity adequate for neuropsychological testing.

3. Completed six grades of education or has a good work history (sufficient to exclude
mental retardation).

4. Must speak English fluently.

5. Willing to undergo one Amyloid imaging PET scan.

6. Agrees to at least one lumbar puncture for the collection of CSF.

7. Must agree to return for a Month 3 and Month 12 visit.

8. Participant, who in the opinion of the investigator, can tolerate the PET scan
procedures

Exclusion Criteria:

1. History of schizophrenia (DSM IV criteria).

2. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV
criteria).

3. Participation in clinical studies involving neuropsychological measures being
collected more than one time per year.

4. 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.

5. 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?

6. 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
We found this trial at
1
site
4201 Belfort Road
Jacksonville, Florida 32216
(408) 293-2336
Principal Investigator: Neill r Graff-Radford, MD
Phone: 904-453-7103
Mayo Clinic Mayo Clinic's campus in Arizona provides medical care for thousands of people from...
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mi
from
Jacksonville, FL
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