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Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

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ClinicalTrials.gov Identifier: NCT01834625
Recruitment Status : Terminated (not recruiting)
First Posted : April 18, 2013
Last Update Posted : February 8, 2018
Sponsor:
Information provided by (Responsible Party):
Neill R. Graff-Radford, M.D., Mayo Clinic

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.


Condition or disease Intervention/treatment
Normal Pressure Hydrocephalus Patients Diagnostic Test: PET scan

Study Type : Observational
Actual Enrollment : 2 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement
Study Start Date : April 2013
Actual Primary Completion Date : March 2017
Actual Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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
Diagnostic Test: PET scan
Florbetapir -ve patients
Florbetapir -ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months
Diagnostic Test: PET scan



Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Clinically evaluated NPH patients
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01834625


Locations
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Neill R Graff-Radford, MD Mayo Clinic

Responsible Party: Neill R. Graff-Radford, M.D., Professor of Neurology, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01834625     History of Changes
Other Study ID Numbers: 11-004532
First Posted: April 18, 2013    Key Record Dates
Last Update Posted: February 8, 2018
Last Verified: February 2018

Additional relevant MeSH terms:
Hydrocephalus
Hydrocephalus, Normal Pressure
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases