Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Neill R. Graff-Radford, M.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01834625
First received: April 15, 2013
Last updated: February 5, 2014
Last verified: February 2014
  Purpose

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 Phase
Normal Pressure Hydrocephalus Patients
Procedure: Shunt surgery
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 25
Study Start Date: April 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01834625

Contacts
Contact: Rita Fletcher, RN 904-953-7103
Contact: Catherine Ruiz 904-953-6523

Locations
United States, Florida
Mayo Clinic Recruiting
Jacksonville, Florida, United States
Contact: Rita Fletcher, RN    904-453-7103      
Principal Investigator: Neill r Graff-Radford, MD         
Sponsors and Collaborators
Mayo Clinic
  More Information

No publications provided

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
Study First Received: April 15, 2013
Last Updated: February 5, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on August 01, 2014