Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

January 31, 2022 updated by: Neill R. Graff-Radford, M.D., Mayo Clinic

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

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Clinically evaluated NPH patients

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
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

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

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Neill R Graff-Radford, MD, Mayo Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (ACTUAL)

March 1, 2017

Study Completion (ACTUAL)

October 1, 2017

Study Registration Dates

First Submitted

April 15, 2013

First Submitted That Met QC Criteria

April 17, 2013

First Posted (ESTIMATE)

April 18, 2013

Study Record Updates

Last Update Posted (ACTUAL)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

February 1, 2018

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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