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Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

This study has been terminated.
(not recruiting)
Information provided by (Responsible Party):
Neill R. Graff-Radford, M.D., Mayo Clinic Identifier:
First received: April 15, 2013
Last updated: March 21, 2017
Last verified: January 2016

In this pilot study the investigators shall prospectively in a blinded fashion evaluate with Aβ PET and CSF Aβ42 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.

Condition Intervention
Normal Pressure Hydrocephalus Patients
Procedure: Shunt surgery

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Participant, Care Provider, Investigator
Primary Purpose: Diagnostic
Official Title: Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 25
Study Start Date: April 2013
Estimated Study Completion Date: July 2017
Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Florbetapir +ve NPH patients
Florbetapir +ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months
Procedure: Shunt surgery
Florbetapir -ve patients
Florbetapir -ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months
Procedure: Shunt surgery


Ages Eligible for Study:   60 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01834625

United States, Florida
Mayo Clinic
Jacksonville, Florida, United States
Sponsors and Collaborators
Mayo Clinic
  More Information

Responsible Party: Neill R. Graff-Radford, M.D., Professor of Neurology, Mayo Clinic Identifier: NCT01834625     History of Changes
Other Study ID Numbers: 11-004532
Study First Received: April 15, 2013
Last Updated: March 21, 2017

Additional relevant MeSH terms:
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on May 24, 2017