Normal Pressure Hydrocephalus PatientsNCT01834625
Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement
An observational study of Normal Pressure Hydrocephalus Patients, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Normal Pressure Hydrocephalus Patients
- What is being tested?
- PET scan
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Clinically evaluated NPH patients
Who may be able to join
- 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
Who cannot join
- 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:
Show all 9Show fewer
- cardiac surgery or myocardial infarction within the last 4 weeks;
- unstable angina;
- acute decompensated congestive heart failure or class IV heart failure
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- PET scan
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET scanDiagnostic test
| Study group | Role | What they receive |
|---|---|---|
| Florbetapir +ve NPH patients | Florbetapir +ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months Receives: Diagnostic Test: PET scan | |
| Florbetapir -ve patients | Florbetapir -ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months Receives: Diagnostic Test: PET scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of change between florbetapir +ve and -ve patients from baseline to one year in the Montreal Cognitive Assessment (MoCA)
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionMar 2017
- Study completionOct 2017
Why it stopped: not recruiting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normal Pressure Hydrocephalus PatientsStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Neill R. Graff-Radford, M.D., Mayo Clinic
- Investigators
- Neill R Graff-Radford, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834625
- Sponsor's protocol ID
- 11-004532
- Status last verified
- Feb 2018
- First submitted
- 15 Apr 2013
- Last updated
- 1 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Aβ Imaging in NPH Prior to Shunt Placement
- ClinicalTrials.gov ID
- NCT01834625
- Acronym / sponsor ID
- 11-004532
- Conditions
- Normal Pressure Hydrocephalus Patients
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: not recruiting
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Mar 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 18 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Florbetapir +ve NPH patients | – | Diagnostic Test: PET scanFlorbetapir +ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months |
| Florbetapir -ve patients | – | Diagnostic Test: PET scanFlorbetapir -ve patients will have neuropsychology tests prior to surgery and then at 3 and 12 months |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Clinically evaluated NPH patients
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET scan | Diagnostic test | Florbetapir +ve NPH patients, Florbetapir -ve patients |
Primary outcome
Comparison of change between florbetapir +ve and -ve patients from baseline to one year in the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline to 1 year
Results and safety
The study was stopped early (reason given: not recruiting). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2022.
Related trials for Normal Pressure Hydrocephalus Patients
Not yet recruitingObservational study
Prediction of Response to Shunt Surgery in Normal Pressure Hydrocephalus Using Radscale and Lumbar Puncture
Idiopathic Normal Pressure Hydrocephalus, Normal Pressure Hydrocephalus
Recruiting
Analysis of Cerebrospinal Fluid Dynamics in Normal Pressure Hydrocephalus
Normal Pressure Hydrocephalus
RecruitingObservational study
Assessment of ShuntCheck Performance Characteristics in Asymptomatic Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
RecruitingObservational study
Diagnostic Accuracy of ShuntCheck Compared to Radionuclide Shunt: Patency in Patients With Normal Pressure Hydrocephalus
Hydrocephalus, Normal Pressure
Not yet recruitingObservational study
Transcranial Ultrasound Assessment of Cerebral Pulsatility in Shunt Decision-making for Suspected Idiopathic Normal Pressure Hydrocephalus: a Prospective Cohort Study
Brain Pulsatility, Idiopathic Normal Pressure Hydrocephalus (INPH)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neill R Graff-Radford, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Normal Pressure Hydrocephalus Patients, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: not recruiting). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of change between florbetapir +ve and -ve patients from baseline to one year in the Montreal Cognitive Assessment (MoCA) (time frame: Baseline to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2022.