Parkinson DiseasePhase 1MPPFNCT01461083
Evaluation of [18F]MPPF as a Brain Tracer of Serotonin Receptor 5HT1a
A Phase 1 study testing [18F]MPPF in people with Parkinson Disease, run by Institute for Neurodegenerative Disorders at 1 site in United States.
Trial summary
The underlying goal of this study is to assess [18F]MPPF PET imaging as a tool to evaluate the activity of the serotonin 5HT1a receptor in the brain of Parkinson Disease (PD) research participants. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- [18F]MPPF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2014
- Phase
- Phase 1
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant is 30 years or older.
- Written informed consent is obtained.
- Participants have a diagnosis of PD (based on UK Brain Bank Criteria).
- Modified Hoehn and Yahr stage of 1 - 4.
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F] CFPyPB injection.
- The participant is 18 years or older.
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- Written informed consent is obtained.
- Negative history of neurological or psychiatric illness based on evaluation by a research physician.
- For females, non-child bearing potential a negative urine or blood pregnancy test on day of [18F]MPPF injection.
Who cannot join
- The subject has a clinically significant laboratory value and/or clinically significant unstable medical or psychiatric illness
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Evidence of a stroke or mass lesion in a clinically relevant area that may interfere with the imaging outcome measure
- Subject treated with medication known to interfere with [18F]MPPF binding in vivo (e.g. pindolol)
- Subjects with radiation exposure above acceptable levels, i.e. a history of exposure to any radiation >15 mSv over the past 12 months.
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- Healthy control subjects
- The subject has a clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
- Evidence of a stroke or mass lesion in a clinically relevant area that may interfere with the imaging outcome measure
- Subject treated with medication known to interfere with [18F]MPPF binding in vivo (e.g. pindolol)
- Subjects with radiation exposure above acceptable levels, i.e. a history of exposure to any radiation >15 mSv over the past 12 months.
Trial locations and contacts
1 site in 1 country.
United States1 site
Molecular NeuroImaging, LLC
New Haven, Connecticut, 06510
About this study
Official title: Phase I Evaluation of [18F]MPPF as a Brain Tracer of Serotonin Receptor 5HT1a in Subjects With Parkinson Disease and Healthy Subjects
The underlying goal of this study is to assess [18F]MPPF PET imaging as a tool to evaluate the activity of the serotonin 5HT1a receptor in the brain of Parkinson Disease (PD) research participants.
Read the detailed description
Approximately 40 subjects with Parkinson disease and 20 healthy control subjects will be recruited to participate in the 2 Projects in this study. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations.
Subjects in Project 1 (20 PD and 20 HC subjects) will be asked to undergo a single bolus injection of [18F]MPPF followed by serial Positron Emission Tomography (PET) imaging scans and blood sampling for measurement of [18F]MPPF in plasma (both protein bound and free) over a period of up to 2 hours. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F]MPPF. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD subjects will be compared with the HC subjects.
Subjects participating in Project 2 (20 PD subjects on dopaminergic replacement therapy) will also undergo a second [18F]MPPF and PET imaging session, identical except that PD medications will be withheld for approximately 8 hours prior to the imaging session. The second session will occur greater than 7 days, but not more than 3 months, from the first imaging session. Initial 'on' medication quantitative outcomes for each brain region will be compared to the outcomes from the second 'off' medication imaging session to determine the influence of dopaminergic treatment on 5HT1A activity.
The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F]MPPF. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD subjects will be compared with the HC subjects.
- Conditions
- Parkinson Disease
- Being tested
- [18F]MPPF
- Keywords
- Parkinson Disease, [18F]MPPF
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]MPPFDrug
Subjects will be dosed by intravenous bolus injection of [18F]MPPF targeted to be 5.0 mCi, and not to exceed 5.5 mCi (not >10% of 5.0 mCi limit) and not to exceed 5 µg of MPPF
| Study group | Role | What they receive |
|---|---|---|
| Assess [18F]MPPF and PET imaging | Experimental | To assess [18F]MPPF and PET imaging Receives: Drug: [18F]MPPF |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the dynamic uptake and washout of [18F]MPPF in brain using positron emission tomography(PET) imaging
To assess the dynamic uptake and washout of [18F]MPPF in brain using positron emission tomography (PET) in Parkinson disease and similarly aged healthy control subjects as a potential imaging biomarker of the serotonin (5HT1A) receptor in brain.
Measured: 2 years
Secondary outcomes (1)
To assess the influence of dopaminergic replacement therapy on 5HT1A activity in PD subjects
To assess the influence of dopaminergic replacement therapy on 5HT1A activity in PD subjects
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completionMay 2014
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
- Interventional
- Phase
- Phase 1
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Neurodegenerative Disorders
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Russell, MD, PhD, Institute for Neurodegenerative Disorders
- Investigators
- David Russell, MD, PhD, Principal investigator, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461083
- Sponsor's protocol ID
- MPPF
- Acronym
- MPPF
- Status last verified
- Jun 2014
- First submitted
- 27 Sep 2011
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Evaluation of [18F]MPPF as a Brain Tracer of Serotonin Receptor 5HT1a in Subjects With Parkinson Disease and Healthy Subjects
- ClinicalTrials.gov ID
- NCT01461083
- Acronym / sponsor ID
- MPPF / MPPF
- Conditions
- Parkinson Disease
- Keywords
- Parkinson Disease, [18F]MPPF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Institute for Neurodegenerative DisordersUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 27 Oct 2011 (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.
The underlying goal of this study is to assess [18F]MPPF PET imaging as a tool to evaluate the activity of the serotonin 5HT1a receptor in the brain of Parkinson Disease (PD) research participants.
Detailed description
Approximately 40 subjects with Parkinson disease and 20 healthy control subjects will be recruited to participate in the 2 Projects in this study. All subjects will undergo written informed consent and a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations.
Subjects in Project 1 (20 PD and 20 HC subjects) will be asked to undergo a single bolus injection of [18F]MPPF followed by serial Positron Emission Tomography (PET) imaging scans and blood sampling for measurement of [18F]MPPF in plasma (both protein bound and free) over a period of up to 2 hours. The imaging analyses will be performed by an image-processing specialist who will remain masked to the procedures employed with each imaging acquisition. The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F]MPPF. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD subjects will be compared with the HC subjects.
Subjects participating in Project 2 (20 PD subjects on dopaminergic replacement therapy) will also undergo a second [18F]MPPF and PET imaging session, identical except that PD medications will be withheld for approximately 8 hours prior to the imaging session. The second session will occur greater than 7 days, but not more than 3 months, from the first imaging session. Initial 'on' medication quantitative outcomes for each brain region will be compared to the outcomes from the second 'off' medication imaging session to determine the influence of dopaminergic treatment on 5HT1A activity.
The primary imaging outcome measure will be the brain regional distribution volumes expressed as a brain tissue to plasma ratio of the radioligand, [18F]MPPF. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD subjects will be compared with the HC subjects.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assess [18F]MPPF and PET imaging | Experimental | Drug: [18F]MPPFTo assess [18F]MPPF and PET imaging |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The participant is 30 years or older.
- Written informed consent is obtained.
- Participants have a diagnosis of PD (based on UK Brain Bank Criteria).
- Modified Hoehn and Yahr stage of 1 - 4.
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F] CFPyPB injection.
Key exclusion criteria (13 listed)
- The subject has a clinically significant laboratory value and/or clinically significant unstable medical or psychiatric illness
- The subject has any disorder that may interfere with drug absorption, distribution, metabolism, or excretion.
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Evidence of a stroke or mass lesion in a clinically relevant area that may interfere with the imaging outcome measure
- Subject treated with medication known to interfere with [18F]MPPF binding in vivo (e.g. pindolol)
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 |
|---|---|---|
| [18F]MPPFSubjects will be dosed by intravenous bolus injection of [18F]MPPF targeted to be 5.0 mCi, and not to exceed 5.5 mCi (not >10% of 5.0 mCi limit) and not to exceed 5 µg of MPPF | Drug | Assess [18F]MPPF and PET imaging |
Primary outcome
To assess the dynamic uptake and washout of [18F]MPPF in brain using positron emission tomography(PET) imaging
Time frame: 2 years
To assess the dynamic uptake and washout of [18F]MPPF in brain using positron emission tomography (PET) in Parkinson disease and similarly aged healthy control subjects as a potential imaging biomarker of the serotonin (5HT1A) receptor in brain.
1 secondary outcome
To assess the influence of dopaminergic replacement therapy on 5HT1A activity in PD subjects
Time frame: 2 years
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 4 Jun 2014.
- Institute for Neurodegenerative DisordersLink provided by the sponsor.
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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.
David Russell, MD, PhD principal investigator
Institute for Neurodegenerative Disorders
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing [18F]MPPF in people with Parkinson Disease, run by Institute for Neurodegenerative Disorders 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 9 inclusion and 13 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 4 Jun 2014. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
To assess the dynamic uptake and washout of [18F]MPPF in brain using positron emission tomography(PET) imaging (time frame: 2 years). 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 4 Jun 2014.