TerminatedNot Applicable

Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

Stopped: not recruiting

United States2 participantsStarted 2013-04

Plain-language 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.

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: Baseline to 1 year

Trial details

NCT IDNCT01834625

SponsorMayo Clinic

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2017-03

View on ClinicalTrials.gov More Normal Pressure Hydrocephalus Patients trials

Plain-language summary

Who can participate

Age range

60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria