Parkinson's DiseasePhase 2NCT00132626
Study of Brain Imaging With Nuclear Technology in Individuals With Parkinsonian Syndrome
A Phase 2 study testing [123I]ß-CIT and SPECT imaging in people with Parkinson's Disease and Parkinsonian Syndrome, run by Institute for Neurodegenerative Disorders.
Trial summary
This study assesses dopamine transporter density using single photon emission computed tomography (SPECT) brain imaging with an investigational radiopharmaceutical, [123I]ß-CIT, in research participants with Parkinson's disease. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Parkinson's Disease, Parkinsonian Syndrome
- What is being tested?
- [123I]ß-CIT and SPECT imaging
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- Sep 1992to Aug 2005
- Phase
- Phase 2
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 21 years of age
- Normal screening laboratory studies
- At least two of the following: resting tremor, cogwheel rigidity, bradykinesia, and postural reflex impairment
Who cannot join
- Pregnancy
- Significant medical disease including abnormalities found on screening
About this study
Official title: Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism
This study assesses dopamine transporter density using single photon emission computed tomography (SPECT) brain imaging with an investigational radiopharmaceutical, [123I]ß-CIT, in research participants with Parkinson's disease.
Read the detailed description
The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period.
After a screening visit, including review of the potential subject's neurological history and a thorough neurologic exam, subjects are injected with [123I]ß CIT, an investigational radioactive material that localizes in the brain.
Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure is used to obtain SPECT (single photon emission computed tomography) images of the brain.
- Conditions
- Parkinson's Disease, Parkinsonian Syndrome
- Being tested
- [123I]ß-CIT and SPECT imaging
- Keywords
- parkinson, diagnosis
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[123I]ß-CIT and SPECT imagingDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness
Secondary outcomes (1)
Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2005 (estimated)
- Study startSep 1992
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants
Sponsor and investigators
- Lead sponsor
- Institute for Neurodegenerative Disorders
- Sponsor type
- University, hospital or other
- Collaborators
- Molecular NeuroImaging, National Institutes of Health (NIH)
- Investigators
- Kenneth Marek, MD, Principal investigator, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00132626
- Sponsor's protocol ID
- Dopamine Transporter Imaging
- Status last verified
- Apr 2019
- First submitted
- 18 Aug 2005
- Last updated
- 3 Apr 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic SPECT Imaging With [123I]ß-CIT in Patients With Parkinsonism
- ClinicalTrials.gov ID
- NCT00132626
- Acronym / sponsor ID
- Dopamine Transporter Imaging
- Conditions
- Parkinson's Disease, Parkinsonian Syndrome
- Keywords
- parkinson, diagnosis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants
- Lead sponsor
- Institute for Neurodegenerative DisordersUniversity, hospital or other
- Collaborators
- Molecular NeuroImaging, National Institutes of Health (NIH)
- Study start
- Sep 1992
- Study completion
- Aug 2005
- First posted
- 22 Aug 2005 (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 study assesses dopamine transporter density using single photon emission computed tomography (SPECT) brain imaging with an investigational radiopharmaceutical, [123I]ß-CIT, in research participants with Parkinson's disease.
Detailed description
The brain imaging is conducted at the Institute for Neurodegenerative Disorders in New Haven, Connecticut. The imaging procedure occurs over a two day period.
After a screening visit, including review of the potential subject's neurological history and a thorough neurologic exam, subjects are injected with [123I]ß CIT, an investigational radioactive material that localizes in the brain.
Twenty-four hours later study participants return to the Institute for Neurodegenerative Disorders where an investigational scanning procedure is used to obtain SPECT (single photon emission computed tomography) images of the brain.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 21 years of age
- Normal screening laboratory studies
- At least two of the following: resting tremor, cogwheel rigidity, bradykinesia, and postural reflex impairment
Key exclusion criteria (2 listed)
- Pregnancy
- Significant medical disease including abnormalities found on screening
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 |
|---|---|---|
| [123I]ß-CIT and SPECT imaging | Drug | – |
Primary outcome
CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness
1 secondary outcome
Measurement of variability of strital uptake of [123I]ß-CIT when more than one scan has occurred
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2019.
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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.
Kenneth Marek, MD principal investigator
Institute for Neurodegenerative Disorders
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing [123I]ß-CIT and SPECT imaging in people with Parkinson's Disease and Parkinsonian Syndrome, run by Institute for Neurodegenerative Disorders.
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 2 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: finished, as of the sponsor's last update on 3 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
CIT uptake: measurement of dopamine transporter density compared with the clinical severity of illness. 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 3 Apr 2019.