Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

NCT01834625 | Terminated

• 1 other identifier: 11-004532
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Normal Pressure Hydrocephalus Patients

Outcome Measures

Primary Outcomes (1)

• Comparison of change between florbetapir +ve and -ve patients from baseline to one year in the Montreal Cognitive Assessment (MoCA)

  Baseline to 1 year

Study Arms (2)

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

Interventions

PET scan DIAGNOSTIC_TEST

Florbetapir +ve NPH patients; Florbetapir -ve patients

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Clinically evaluated NPH patients

You may qualify if:

• Age ≥ 60.
• Visual and auditory acuity adequate for neuropsychological testing.
• Completed six grades of education or has a good work history (sufficient to exclude mental retardation).
• Must speak English fluently.
• Willing to undergo one Amyloid imaging PET scan.
• Agrees to at least one lumbar puncture for the collection of CSF.
• Must agree to return for a Month 3 and Month 12 visit.
• Participant, who in the opinion of the investigator, can tolerate the PET scan procedures

You may not qualify if:

• History of schizophrenia (DSM IV criteria).
• History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria).
• Participation in clinical studies involving neuropsychological measures being collected more than one time per year.
• 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?
• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic

Jacksonville, Florida, 32224, United States

Location

MeSH Terms

Interventions

Positron-Emission Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Neill R Graff-Radford, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: April 15, 2013
• First Posted: April 18, 2013
• Study Start: April 1, 2013
• Primary Completion: March 1, 2017
• Study Completion: October 1, 2017
• Last Updated: February 1, 2022

Record last verified: 2018-02

Locations

US (1)