Parkinson DiseasePhase 1NCT01461109
Research Involving Subjects With Parkinson's Disease, Alzheimer Disease and Healthy Controls
A Phase 1 study testing [18F] CFPyPB in people with Parkinson Disease and Alzheimer 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] CFPyPB PET imaging as a tool to evaluate the activity of the GlyT1 receptors in the brain of Parkinson's Disease (PD) and Alzheimer Disease (AD) 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, Alzheimer Disease
- What is being tested?
- [18F] CFPyPB
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 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
PD subject inclusion criteria:
- 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.
PD subject exclusion criteria:
- The subject has a 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.
- 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 contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan.
- The subject is a pregnant or nursing mother
AD subject inclusion criteria:
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of probable Alzheimer disease in accordance with the DSM-IV-TR and according to (NINCDS/ADRDA) criteria.
- Participants do not fulfill the ICC criteria for probable DLB, the NINDS-AIREN for probable vascular dementia, or the Neary [Neary, et al. 1998] criteria for FTD.
- Clinical Dementia Rating Scale score 0.5, 1 or 2.
- Modified Hachinski Ischemia Scale score of ≤ 4.
- Geriatric Depression Scale (GDS) ≤ 10.
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F] CFPyPB injection.
AD subject exclusion criteria:
- The subject has a 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.
- 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 contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan.
- The subject is a pregnant or nursing mother.
Healthy volunteer inclusion criteria:
- The participant is 18 years or older.
- 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] CFPyPB injection.
Healthy volunteer exclusion criteria:
- 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.
- The subject has any contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan.
- The subject is a pregnant or nursing mother.
Trial locations and contacts
1 site in 1 country.
United States1 site
Institute_Neurodegenerative_Disorders
New Haven, Connecticut, 06510
About this study
Official title: Evaluation of [18F] CFPyPB PET as a Marker of Glycine Transporter-1 (GlyT1) Receptor in Subjects With Parkinson Disease, Alzheimer Disease and Healthy Subjects
The underlying goal of this study is to assess [18F] CFPyPB PET imaging as a tool to evaluate the activity of the GlyT1 receptors in the brain of Parkinson's Disease (PD) and Alzheimer Disease (AD) research participants.
Read the detailed description
Approximately 6 subjects with Parkinson disease, 6 subjects with Alzheimer disease and 20 healthy control subjects will be recruited to participate 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 will be asked to undergo a bolus injection of [18F] CFPyPB followed by serial PET imaging scans and plasma sampling for measurement of [18F] CFPyPB in plasma (both protein bound and free) over a period of up to 4 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] CFPyPB. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD and AD subjects will be compared with the HC subjects.
At least 2 weeks following the initial imaging visit subjects (up to 2 PD subjects, up to 2 AD subjects and up to 5 HC subjects) may be asked to return for a second injection and scanning procedure to evaluate the reproducibility of the imaging measure using this procedure. Subjects may decline participation in the second scan. Subjects will be requested to return for this second scan until enough second scan data is collected to evaluate the imaging outcome measure for reproducibility.
- Conditions
- Parkinson Disease, Alzheimer Disease
- Being tested
- [18F] CFPyPB
- Keywords
- Parkinson Disease, Alzheimer Disease, [18F] CFPyPB, GlyT1
- Medical subject headings
- Parkinson Disease, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F] CFPyPBDrug
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]CFPyPB or 5 μg of CFPyPB (whichever is greatest).
| Study group | Role | What they receive |
|---|---|---|
| Assess [18F] CFPyPB and PET imaging | Experimental | To assess [18F]CFPyPB and PET imaging Receives: Drug: [18F] CFPyPB |
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] CFPyPB
To assess the dynamic uptake and washout of [18F] CFPyPB, an imaging tracer targeting the glycine transporter-1 (GlyT1) receptor in brain, using positron emission tomography (PET) in subjects with Parkinson disease (PD) Alzheimer disease (AD) and healthy controls (HC).
Measured: Approximately 2 years
Secondary outcomes (3)
Perform blood metabolite characterization of [18F] CFPyPB
To perform blood metabolite characterization of [18F] CFPyPB in subjects with PD, AD and HC to determine the nature of metabolites in assessment of [18F] CFPyPB as a single positron computed tomography (PET) brain imaging agent.
Measured: Approximately 2 years
To obtain safety data
To acquire safety data following injection of [18F] CFPyPB
Measured: Approximately 2 years
Obtain test/retest reproductibility
To obtain test/retest reproducibility of quantitative PET outcome measures with [18F] CFPyPB
Measured: Approximately 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 startAug 2011
- Primary completionSep 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
- 4 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
- NCT01461109
- Sponsor's protocol ID
- GlyT1-01
- Status last verified
- Jun 2014
- First submitted
- 27 Sep 2011
- Last updated
- 4 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
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
- Evaluation of [18F] CFPyPB PET as a Marker of Glycine Transporter-1 (GlyT1) Receptor in Subjects With Parkinson Disease, Alzheimer Disease and Healthy Subjects
- ClinicalTrials.gov ID
- NCT01461109
- Acronym / sponsor ID
- GlyT1-01
- Conditions
- Parkinson Disease, Alzheimer Disease
- Keywords
- Parkinson Disease, Alzheimer Disease, [18F] CFPyPB, GlyT1
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Institute for Neurodegenerative DisordersUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Sep 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] CFPyPB PET imaging as a tool to evaluate the activity of the GlyT1 receptors in the brain of Parkinson's Disease (PD) and Alzheimer Disease (AD) research participants.
Detailed description
Approximately 6 subjects with Parkinson disease, 6 subjects with Alzheimer disease and 20 healthy control subjects will be recruited to participate 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 will be asked to undergo a bolus injection of [18F] CFPyPB followed by serial PET imaging scans and plasma sampling for measurement of [18F] CFPyPB in plasma (both protein bound and free) over a period of up to 4 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] CFPyPB. Time to the peak uptake and amplitude of the peak uptake will be evaluated for all brain regions and the results for the PD and AD subjects will be compared with the HC subjects.
At least 2 weeks following the initial imaging visit subjects (up to 2 PD subjects, up to 2 AD subjects and up to 5 HC subjects) may be asked to return for a second injection and scanning procedure to evaluate the reproducibility of the imaging measure using this procedure. Subjects may decline participation in the second scan. Subjects will be requested to return for this second scan until enough second scan data is collected to evaluate the imaging outcome measure for reproducibility.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assess [18F] CFPyPB and PET imaging | Experimental | Drug: [18F] CFPyPBTo assess [18F]CFPyPB and PET imaging |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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] CFPyPBEach 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]CFPyPB or 5 μg of CFPyPB (whichever is greatest). | Drug | Assess [18F] CFPyPB and PET imaging |
Primary outcome
To assess the dynamic uptake and washout of [18F] CFPyPB
Time frame: Approximately 2 years
To assess the dynamic uptake and washout of [18F] CFPyPB, an imaging tracer targeting the glycine transporter-1 (GlyT1) receptor in brain, using positron emission tomography (PET) in subjects with Parkinson disease (PD) Alzheimer disease (AD) and healthy controls (HC).
3 secondary outcomes
Perform blood metabolite characterization of [18F] CFPyPB
Time frame: Approximately 2 years
To obtain safety data
Time frame: Approximately 2 years
Obtain test/retest reproductibility
Time frame: Approximately 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] CFPyPB in people with Parkinson Disease and Alzheimer 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?
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] CFPyPB (time frame: Approximately 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.