Parkinson DiseasePhase 1FPEBNCT00870974
A PET Brain Imaging Study of mGluR5 in Subjects With Neuropsychiatric Conditions
A Phase 1 study testing [18F]FPEB in people with Parkinson Disease and Huntington Disease, run by Institute for Neurodegenerative Disorders at 1 site in United States.
Trial summary
Measurement of metabotropic glutamate receptor type 5 (mGluR5) binding capacity in the brain, may be a valuable tool in the early detection, understanding, or evaluation of Parkinson disease (PD), Huntington disease (HD), Fragile X syndrome (FXS), Autism Spectrum Disorder(ASD), Alzheimer's Disease(AD), and subjects… Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease, Huntington Disease, Autistic Spectrum Disorders
- What is being tested?
- [18F]FPEB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to Nov 2016
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PD subjects:
- Age 30 years or older.
- Clinical diagnosis of PD with at least two of three of the cardinal symptoms of PD (rest tremor, rigidity, bradykinesia)
- Hoehn and Yahr[35] ≤ 4.
- HD subjects:
- Age 18 years or older.
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- Participants have a clinical diagnosis of symptomatic HD with genetic confirmation
- Subject is able to provide informed consent as judged by the investigator, or assent can be obtained from the subject and informed consent provided by the appropriate legal representative or next of kin.
- Healthy volunteers should be 18 years of age or older and have a negative history of neurological or psychiatric illness.
- ASD and/or FRAGILE X:
- Age 18 years or older
- Clinical diagnosis of ASD and/or FXS
- Diagnosis of FXS based on gene testing or diagnosis of ASD based on DSM-IV criteria
- AD subjects:
- Participants have a positive assessment for dementia of Alzheimer type in accordance with the DSM-IV-TR and probable AD according to the NINCDS-ADRDA criteria.
- Participants do not fulfill the ICC criteria for probable DLB, the NINDS-AIREN for probable vascular dementia, or the Neary criteria for FTD.
- CDR score of 0.5, 1 or 2.
- MCI subjects:
- Participants must have a complaint of memory loss, objective impairment in at least one cognitive domain, essentially preserved activities of daily living, and do not meet diagnostic criteria for AD or other form of dementia. Participants do not fulfill the ICC criteria for probable DLB, the NINDS-AIREN for probable vascular dementia, or the Neary criteria for FTD.
- CDR score of ≤ 0.5.
- AD and MCI:
- Age 50 years or older.
- MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease. Exclusion criterion may be waived if, in the judgment of the investigator (1) vascular dementia is clinically unlikely and (2) the subject is deemed unable to tolerate the MRI procedure due to claustrophobia, etc.
Who cannot join
- PD, HD and ASD and/or Fragile X subjects:
- Clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- Any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including significant gastrointestinal surgery).
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Clinically significant evidence of vascular disease or alternative neurologic disorder
- Healthy volunteers:
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- Clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
- Any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including significant gastrointestinal surgery).
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- AD and MCI subjects:
- The subject has clinically significant abnormal 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 (including significant gastrointestinal surgery).
- The subject has evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
About this study
Official title: Evaluation of [18F]PEB and Positron Emission Tomography (PET) as a Marker of mGluR5 in Subjects w/ Neuropsychiatric Conditions
Measurement of metabotropic glutamate receptor type 5 (mGluR5) binding capacity in the brain, may be a valuable tool in the early detection, understanding, or evaluation of Parkinson disease (PD), Huntington disease (HD), Fragile X syndrome (FXS), Autism Spectrum Disorder(ASD), Alzheimer's Disease(AD), and subjects with mild cognitive impairment (MCI).
The goal of this study is to assess [18F]F-PEB positron emission tomography (PET) imaging as a tool to detect mGluR5 density in the brain of PD, HD, FXS ASD, AD, and MCI research participants and similarly aged healthy subjects.
Read the detailed description
Informed consent will be obtained for all subjects. All subjects will undergo a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. All subjects will undergo [18F]F-PEB PET imaging. Subjects may also be asked to undergo standard brain MRI to assist in the analysis of the PET images obtained.
- Conditions
- Parkinson Disease, Huntington Disease, Autistic Spectrum Disorders, Fragile X Syndrome, Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- [18F]FPEB
- Keywords
- Parkinson, Huntington's, Fragile X, Autistic Spectrum, Alzheimer's, MCI
- Medical subject headings
- Parkinson Disease, Huntington Disease, Autism Spectrum Disorder, Fragile X Syndrome, Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]FPEBDrug
Also called Fluorine-18
Each subject will receive a bolus injection targeted to be 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of [18F]F-PEB
| Study group | Role | What they receive |
|---|---|---|
| Assess [18F]FPEB and PET imaging | Experimental | To assess [18F] FPEB and PET imaging in subjects with neuropsychiatric conditions. Receives: Drug: [18F]FPEB |
What is being measured
The primary outcome is the main question the study is designed to answer.
Does FPEB reliably represent the known distribution of MGLUR5 in the brain?
Measured: at completion of scans
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startMar 2009
- Primary completionOct 2016
- Study completionNov 2016
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
- 48 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, Principal investigator, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870974
- Sponsor's protocol ID
- FPEB
- Acronym
- FPEB
- Status last verified
- Jan 2017
- First submitted
- 26 Mar 2009
- Last updated
- 6 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of [18F]PEB and Positron Emission Tomography (PET) as a Marker of mGluR5 in Subjects w/ Neuropsychiatric Conditions
- ClinicalTrials.gov ID
- NCT00870974
- Acronym / sponsor ID
- FPEB / FPEB
- Conditions
- Parkinson Disease, Huntington Disease, Autistic Spectrum Disorders, Fragile X Syndrome, Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Parkinson, Huntington's, Fragile X, Autistic Spectrum, Alzheimer's, MCI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Institute for Neurodegenerative DisordersUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 27 Mar 2009 (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.
Measurement of metabotropic glutamate receptor type 5 (mGluR5) binding capacity in the brain, may be a valuable tool in the early detection, understanding, or evaluation of Parkinson disease (PD), Huntington disease (HD), Fragile X syndrome (FXS), Autism Spectrum Disorder(ASD), Alzheimer's Disease(AD), and subjects with mild cognitive impairment (MCI).
The goal of this study is to assess [18F]F-PEB positron emission tomography (PET) imaging as a tool to detect mGluR5 density in the brain of PD, HD, FXS ASD, AD, and MCI research participants and similarly aged healthy subjects.
Detailed description
Informed consent will be obtained for all subjects. All subjects will undergo a screening evaluation including baseline clinical laboratory testing, a baseline physical and neurological evaluation and baseline cognitive evaluations. All subjects will undergo [18F]F-PEB PET imaging. Subjects may also be asked to undergo standard brain MRI to assist in the analysis of the PET images obtained.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assess [18F]FPEB and PET imaging | Experimental | Drug: [18F]FPEBTo assess [18F] FPEB and PET imaging in subjects with neuropsychiatric conditions. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- Age 30 years or older.
- Clinical diagnosis of PD with at least two of three of the cardinal symptoms of PD (rest tremor, rigidity, bradykinesia)
- Hoehn and Yahr[35] ≤ 4.
- Age 18 years or older.
- Participants have a clinical diagnosis of symptomatic HD with genetic confirmation
Key exclusion criteria (13 listed)
- Clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- Any disorder that may interfere with drug absorption distribution, metabolism, or excretion (including significant gastrointestinal surgery).
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Clinically significant evidence of vascular disease or alternative neurologic disorder
- Clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness.
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]FPEBAlso: Fluorine-18Each subject will receive a bolus injection targeted to be 5 mCi and not to exceed 5.5 mCi (not >10% of 5 mCi limit) of [18F]F-PEB | Drug | Assess [18F]FPEB and PET imaging |
Primary outcome
Does FPEB reliably represent the known distribution of MGLUR5 in the brain?
Time frame: at completion of scans
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 6 Jan 2017.
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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 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]FPEB in people with Parkinson Disease and Huntington 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 23 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 6 Jan 2017. 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?
Does FPEB reliably represent the known distribution of MGLUR5 in the brain? (time frame: at completion of scans). 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 6 Jan 2017.