Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

NCT ID: NCT01834625

Last Updated: 2022-02-01

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 2 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-10-31

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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Florbetapir +ve NPH patients

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

PET scan

Intervention Type: DIAGNOSTIC_TEST

Florbetapir -ve patients

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

PET scan

Intervention Type: DIAGNOSTIC_TEST

Interventions

PET scan

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Neill R. Graff-Radford, M.D.

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neill R Graff-Radford, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Jacksonville, Florida, United States

Countries

United States

Other Identifiers

11-004532

Identifier Type: -

Identifier Source: org_study_id