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

April 15, 2013
February 5, 2014
April 2013
May 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01834625 on ClinicalTrials.gov Archive Site
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Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement
Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

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.

Not Provided
Interventional
Phase 0
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Diagnostic
Normal Pressure Hydrocephalus Patients
Procedure: Shunt surgery
  • Florbetapir +ve NPH patients
    Florbetapir +ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months
    Intervention: Procedure: Shunt surgery
  • Florbetapir -ve patients
    Florbetapir -ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months
    Intervention: Procedure: Shunt surgery
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
May 2014
May 2014   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact: Rita Fletcher, RN 904-953-7103
Contact: Catherine Ruiz 904-953-6523
United States
 
NCT01834625
11-004532
No
Neill R. Graff-Radford, M.D., Mayo Clinic
Mayo Clinic
Not Provided
Not Provided
Mayo Clinic
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP