Prognostic Value of Aβ Imaging in NPH Prior to Shunt Plac... | NCT01834625

Studies
Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

NCT01834625

Sponsor

Mayo Clinic

Status

Terminated

Last Update Posted

Feb 1, 2022Actual

Enrollment

2Actual

Phase

Not provided

Conditions

Normal Pressure Hydrocephalus Patients

Interventions

PET scan

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

not recruiting

Expanded Access Info

Start Date

Apr 2013

Primary Completion Date

Mar 2017Actual

Completion Date

Oct 2017Actual

First Submitted Date

Apr 15, 2013

First Submission Date that Met QC Criteria

Apr 17, 2013

First Posted Date

Apr 18, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 31, 2022

Last Update Posted Date

Feb 1, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
PET scan	Diagnostic Test		Florbetapir +ve NPH patients Florbetapir -ve patients

Measure	Description	Time Frame
Comparison of change between florbetapir +ve and -ve patients from baseline to one year in the Montreal Cognitive Assessment (MoCA)		Baseline to 1 year

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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.
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.
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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Clinically evaluated NPH patients

Sampling Method

Non-Probability Sample

ID	Term
D014055	Tomography, Emission-Computed
D007090	Image Interpretation, Computer-Assisted
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures