Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

Mayo Clinic

Status: Terminated

Conditions: Normal Pressure Hydrocephalus Patients

Treatments: Diagnostic Test: PET scan

Study type: Observational

Funder types: Other

Identifiers

NCT01834625

11-004532

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

2 participants in 2 patient groups

Florbetapir +ve NPH patients

Description:

Florbetapir +ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months

Treatment:

Diagnostic Test: PET scan

Florbetapir -ve patients

Description:

Florbetapir -ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months

Treatment:

Diagnostic Test: PET scan