Parkinson DiseaseNCT02138682
Validation of DaTscan for Detection of Parkinson Disease Related Disorders
An observational study of Parkinson Disease and Movement Disorders, run by Wisconsin Institute for Neurologic and Sleep Disorders S.C. at 2 sites in United States.
Trial summary
This investigator initiated trial is designed to measure the accuracy of diagnosis of Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure dopamine transporter densities in human tissue. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Parkinson Disease, Movement Disorders
- What is being tested?
- l-123 Ioflupane
- How many people
- 20 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2014to Apr 2016
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Parkinson disease patients from Wisconsin Institute for Neurologic and Sleep Disorders, SC.
Who may be able to join
- aged 75 or older
- sporadic late onset Parkinson disease or one of its variants
- registered in tissue donation program
Who cannot join
- aged less than 75 years old
- mental status preventing neuroimaging or transportation to site
- inability to remain "relatively steady" during the scanning procedure
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Wisconsin Institute for Neurologic and Sleep Disorders, SC
Milwaukee, Wisconsin, 53233
About this study
Official title: Validation of DaTscan for Detection of Parkinsonian Disease and Related Disorders Using Neuropathologically-confirmed Parkinson Disease From Human Brain Tissue
This investigator initiated trial is designed to measure the accuracy of diagnosis of Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure dopamine transporter densities in human tissue. This measurement can assist in distinguishing between Essential Tremor and Parkinsonian Syndromes (idiopathic Parkinson disease, Progressive Supranuclear Palsy, Multi Systems Atrophy, etc). This study will compare both clinical diagnosis of symptoms and the results of the scan to the pathological diagnosis received at time of death. Patients will be registered in the Parkinson Research Institute's brain donation program, receive a clinical diagnosis of Parkinson disease, have their brain scanned using DaTscan, and donate their tissue for research and autopsy purposes. The hypothesis of the study is that DaTscan will diagnosis Idiopathic Parkinson Disease as accurately as a clinician.
- Conditions
- Parkinson Disease, Movement Disorders
- Being tested
- l-123 Ioflupane
- Keywords
- DaT-SPECT scan, Parkinson's, Diagnostic
- Medical subject headings
- Parkinson Disease, Movement Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
l-123 IoflupaneDrug
Also called DaTscan
5 millicuries of Ioflupane
| Study group | Role | What they receive |
|---|---|---|
| l-123 Ioflupane | Study group includes those clinically diagnosed with Parkinson disease who are aged 75 and older who have agreed to donate brain tissue at time of death and are able to participate in the imaging scan process. Receives: Drug: l-123 Ioflupane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Consistency Between Diagnostic Procedures
Consistency of diagnosis between: (1) clinical diagnosis, (2) scan results, and (3) pathological results.
Measured: Will be assessed upon receipt of autopsy report- time frame per patient is 24 months from enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wisconsin Institute for Neurologic and Sleep Disorders S.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wisconsin Parkinson Association, Medical College of Wisconsin, GE Healthcare
- Responsible party
- Principal investigator, Paul Nausieda, Wisconsin Institute for Neurologic and Sleep Disorders S.C.
- Investigators
- Paul A Nausieda, MD, Principal investigator, Wisconsin Institute for Neurologic and Sleep Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02138682
- Sponsor's protocol ID
- 12-DAT-014
- Status last verified
- Jul 2014
- First submitted
- 24 Apr 2014
- Last updated
- 16 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of DaTscan for Detection of Parkinsonian Disease and Related Disorders Using Neuropathologically-confirmed Parkinson Disease From Human Brain Tissue
- ClinicalTrials.gov ID
- NCT02138682
- Acronym / sponsor ID
- 12-DAT-014
- Conditions
- Parkinson Disease, Movement Disorders
- Keywords
- DaT-SPECT scan, Parkinson's, Diagnostic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wisconsin Institute for Neurologic and Sleep Disorders S.C.Industry (pharma, biotech, devices)
- Collaborators
- Wisconsin Parkinson Association, Medical College of Wisconsin, GE Healthcare
- Study start
- Jul 2014
- Primary completion
- Apr 2016 (estimated)
- First posted
- 14 May 2014 (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.
This investigator initiated trial is designed to measure the accuracy of diagnosis of Parkinson disease through the use of DaTscan. Currently, DaTscan is FDA approved to measure dopamine transporter densities in human tissue. This measurement can assist in distinguishing between Essential Tremor and Parkinsonian Syndromes (idiopathic Parkinson disease, Progressive Supranuclear Palsy, Multi Systems Atrophy, etc). This study will compare both clinical diagnosis of symptoms and the results of the scan to the pathological diagnosis received at time of death. Patients will be registered in the Parkinson Research Institute's brain donation program, receive a clinical diagnosis of Parkinson disease, have their brain scanned using DaTscan, and donate their tissue for research and autopsy purposes. The hypothesis of the study is that DaTscan will diagnosis Idiopathic Parkinson Disease as accurately as a clinician.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| l-123 Ioflupane | – | Drug: l-123 IoflupaneStudy group includes those clinically diagnosed with Parkinson disease who are aged 75 and older who have agreed to donate brain tissue at time of death and are able to participate in the imaging scan process. |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Parkinson disease patients from Wisconsin Institute for Neurologic and Sleep Disorders, SC.
Key inclusion criteria (3 listed)
- aged 75 or older
- sporadic late onset Parkinson disease or one of its variants
- registered in tissue donation program
Key exclusion criteria (3 listed)
- aged less than 75 years old
- mental status preventing neuroimaging or transportation to site
- inability to remain "relatively steady" during the scanning procedure
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 |
|---|---|---|
| l-123 IoflupaneAlso: DaTscan5 millicuries of Ioflupane | Drug | l-123 Ioflupane |
Primary outcome
Consistency Between Diagnostic Procedures
Time frame: Will be assessed upon receipt of autopsy report- time frame per patient is 24 months from enrollment.
Consistency of diagnosis between: (1) clinical diagnosis, (2) scan results, and (3) pathological results.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2014.
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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.
Paul A Nausieda, MD principal investigator
Wisconsin Institute for Neurologic and Sleep Disorders
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease and Movement Disorders, run by Wisconsin Institute for Neurologic and Sleep Disorders S.C. at 2 sites 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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 16 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
Consistency Between Diagnostic Procedures (time frame: Will be assessed upon receipt of autopsy report- time frame per patient is 24 months from enrollment.). 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 16 Jul 2014.