Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

Terminated

• Conditions: Normal Pressure Hydrocephalus Patients
• Interventions: Diagnostic Test: PET scan

• Registration Number: NCT01834625
• Lead Sponsor: Mayo Clinic

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 available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-15
• Study First Submitted QC: 2013-04-17
• Study First Posted: 2013-04-18
• Primary Completion: 2017-03
• Study Completion: 2017-10
• Status Verified: 2018-02
• Last Update Submitted: 2022-01-31
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Florbetapir +ve NPH patients	PET scan	Florbetapir +ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months
Florbetapir -ve patients	PET scan	Florbetapir -ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months

Primary Outcome Measures

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

Trial Locations

Locations (1)

Mayo Clinic; 🇺🇸 Jacksonville, Florida, United States