Alzheimer DiseasePhase 1PBR111NCT01209156
Evaluation of [18F] PBR111 and PET as a Marker of Inflammation in Subjects With Neurological Conditions
A Phase 1 study testing [18F] PBR111 in people with 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 PBR-111 positron emission tomography (PET) imaging as a tool to detect microglial activation in the brain of Alzheimer disease (AD) research participants and age- and gender-matched healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- [18F] PBR111
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Jun 2013
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of probable Alzheimer disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
- Does not fulfill the ICC criteria for probable DLB (Appendix 3), the NINDS-AIREN for probable Vascular dementia (Appendix 5), or the Neary [Neary et al. 1998] criteria for FTD (Appendix 4)
- Clinical Dementia Rating Scale score ≤ 2.
- Modified Hachinski Ischemia Scale score of ≤ 4.
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- MRI brain scan findings that do not reveal changes indicative of stroke and/or generalized cerebrovascular disease (e.g., the ARWMC scale) changes limited to: a white matter lesion score of 0 or 1 or 2 and a basal ganglia score of 0 or 1)
- has a caregiver willing and able to attend all study visits and perform the psychometric tests requiring the presence of a caregiver
- For females, non-child bearing potential or a negative urine or blood pregnancy test on day of [18F]-PBR111 injection.
- The participant is 18 years or older, with at least 4 subjects ≥50 years.
- Written informed consent is obtained.
- Negative history of neurological or psychiatric illness based on evaluation by a research physician.
- Has no evidence of cognitive impairment as indicated by a clinical dementia rating (CDR, [Hughes et al. 1993]) score of 0 (zero) and a score of ≥ 28 in the Mini-Mental Status Examination (MMSE, [Folstein et al. 1975]) Clinical Dementia Rating score = 0.
- has MRI brain scan that has been judged as "normal (age- appropriate)" including ARWMC scale [Wahlund et al. 2001] scores supporting the lack of cerebrovascular disease (e.g., a white matter lesion score of 0 or 1 or 2 and a basal ganglia score of 0 or 1) and a Scheltens scale [Scheltens et al. 1992] verifying the lack of cerebral atrophy (e.g. bilateral temporal lobe atrophy visual score of 0 or 1)
- For females, non-child bearing potential a negative urine or blood pregnancy test on day of [18F]-PBR-111 injection.
Who cannot join
- History of significant cerebrovascular disease.
- Clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
- Contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan
- History of exposure to any radiation >15 mSv/year (e.g. occupational or radiation therapy)
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- Receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
- Received anti-amyloid drug therapy.
- History of significant cerebrovascular disease.
- Clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
- Contraindication to MRI examination, e.g. metal implants or phobia as determined by the on-site radiologist performing the scan
- History of exposure to any radiation >15 mSv/year (e.g. occupational or radiation therapy)
- Receiving drug therapy or other treatment that is known to lead to greatly fluctuating values of the hematological or chemical laboratory parameters or to severe side effects (e.g. chemotherapy)
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: A Phase 1 Evaluation of the Kinetics, Clearance and Cerebral Distribution of One Novel PBR PET Imaging Agent, 18F-PBR-111 Following Intravenous Administration in Healthy Subjects and Alzheimer Disease Patients
The underlying goal of this study is to assess PBR-111 positron emission tomography (PET) imaging as a tool to detect microglial activation in the brain of Alzheimer disease (AD) research participants and age- and gender-matched healthy volunteers.
Read the detailed description
This is a phase 1, open-label, single-center, non-randomized single dose study to assess the kinetics, clearance and cerebral distribution of PBR-111 positron emission tomography (PET) imaging in detecting microglial activation in the brain in patients with probable Alzheimer disease (AD) compared to healthy volunteers (HVs). All aspects related to image acquisition, processing and visual as well as quantitative evaluation will be developed, optimized and validated (where required).
Each subject will be required to visit the study center during the screening phase and on the PBR-111 PET imaging day (baseline). A telephone follow-up visit will be performed 7 days (+/- 3 days) after PBR-111 PET administration.
At the screening visit, each subject (or caregiver in the case of AD subjects) will be asked to provide written informed consent or assent. During the screening phase (maximum duration - 60 days) subject medical, neurological and surgical history, clinical assessments and a neuro-psychiatric evaluation will be performed on all eligible subjects. Subjects will be allowed to leave the center after all evaluations have been completed. During this period an MRI of the brain will be performed. During the PBR-111 PET imaging day, all subjects will receive a single IV injection of PBR-111 and scanning will be performed over a 3.5 hour period. Each subject will have a telephone follow-up 7 days (+/- 3 days) thereafter to assess for adverse events.
- Conditions
- Alzheimer Disease
- Being tested
- [18F] PBR111
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F] PBR111Drug
Subjects will be injected with 5mCi (not to exceed a maximum of 5.5 mCi) of [18F]PBR111, followed by PET imaging.
| Study group | Role | What they receive |
|---|---|---|
| Assess [18F] PBR111 and PET imaging | Experimental | Evaluation of PET imaging with [18F]PBR111 in HV and AD subjects (Proof of Mechanism) Receives: Drug: [18F] PBR111 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the cerebral distribution of [18F]PBR-111 positron emission tomography (PET) for detection/exclusion of microglial activation in patients with Alzheimer Disease compared to healthy volunteers.
Measured: 1 year
Secondary outcomes (2)
To assess the dynamic uptake and washout of [18F]PBR-111, a potential imaging biomarker for inflammatory changes in brain, using positron emission tomography (PET) in Alzheimer disease subjects compared to healthy volunteers.
Measured: 1 year
To perform blood metabolite characterization of [18F]PBR-111 in AD subjects compared to Healthy volunteers to determine the nature of metabolites in assessment of [18F]PBR-111 as a single positron computed tomography (PET) brain imaging agent.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2010 (estimated)
- Study startMar 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer 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
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Neurodegenerative Disorders
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danna Jennings, MD, Institute for Neurodegenerative Disorders
- Investigators
- Danna Jennings, MD, Principal investigator, Institute for Neurodegenerative Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01209156
- Sponsor's protocol ID
- PBR111 001
- Acronym
- PBR111
- Status last verified
- Nov 2013
- First submitted
- 20 Sep 2010
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Evaluation of the Kinetics, Clearance and Cerebral Distribution of One Novel PBR PET Imaging Agent, 18F-PBR-111 Following Intravenous Administration in Healthy Subjects and Alzheimer Disease Patients
- ClinicalTrials.gov ID
- NCT01209156
- Acronym / sponsor ID
- PBR111 / PBR111 001
- Conditions
- Alzheimer Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Institute for Neurodegenerative DisordersUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 27 Sep 2010 (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 PBR-111 positron emission tomography (PET) imaging as a tool to detect microglial activation in the brain of Alzheimer disease (AD) research participants and age- and gender-matched healthy volunteers.
Detailed description
This is a phase 1, open-label, single-center, non-randomized single dose study to assess the kinetics, clearance and cerebral distribution of PBR-111 positron emission tomography (PET) imaging in detecting microglial activation in the brain in patients with probable Alzheimer disease (AD) compared to healthy volunteers (HVs). All aspects related to image acquisition, processing and visual as well as quantitative evaluation will be developed, optimized and validated (where required).
Each subject will be required to visit the study center during the screening phase and on the PBR-111 PET imaging day (baseline). A telephone follow-up visit will be performed 7 days (+/- 3 days) after PBR-111 PET administration.
At the screening visit, each subject (or caregiver in the case of AD subjects) will be asked to provide written informed consent or assent. During the screening phase (maximum duration - 60 days) subject medical, neurological and surgical history, clinical assessments and a neuro-psychiatric evaluation will be performed on all eligible subjects. Subjects will be allowed to leave the center after all evaluations have been completed. During this period an MRI of the brain will be performed. During the PBR-111 PET imaging day, all subjects will receive a single IV injection of PBR-111 and scanning will be performed over a 3.5 hour period. Each subject will have a telephone follow-up 7 days (+/- 3 days) thereafter to assess for adverse events.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assess [18F] PBR111 and PET imaging | Experimental | Drug: [18F] PBR111Evaluation of PET imaging with [18F]PBR111 in HV and AD subjects (Proof of Mechanism) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- The participant is 50 years or older.
- Written informed consent is obtained.
- Participants have a clinical diagnosis of probable Alzheimer disease based on National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer Disease and Related Disorders Association (NINCDS/ADRDA) criteria.
- Does not fulfill the ICC criteria for probable DLB (Appendix 3), the NINDS-AIREN for probable Vascular dementia (Appendix 5), or the Neary [Neary et al. 1998] criteria for FTD (Appendix 4)
- Clinical Dementia Rating Scale score ≤ 2.
Key exclusion criteria (15 listed)
- History of significant cerebrovascular disease.
- Clinically significant abnormal laboratory value and/or clinically significant unstable medical or psychiatric illness
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Pregnancy
- Contraindication to MRI examination, e.g. metal implants or phobia as determined by the onsite radiologist performing the scan
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] PBR111Subjects will be injected with 5mCi (not to exceed a maximum of 5.5 mCi) of [18F]PBR111, followed by PET imaging. | Drug | Assess [18F] PBR111 and PET imaging |
Primary outcome
To evaluate the cerebral distribution of [18F]PBR-111 positron emission tomography (PET) for detection/exclusion of microglial activation in patients with Alzheimer Disease compared to healthy volunteers.
Time frame: 1 year
2 secondary outcomes
To assess the dynamic uptake and washout of [18F]PBR-111, a potential imaging biomarker for inflammatory changes in brain, using positron emission tomography (PET) in Alzheimer disease subjects compared to healthy volunteers.
Time frame: 1 year
To perform blood metabolite characterization of [18F]PBR-111 in AD subjects compared to Healthy volunteers to determine the nature of metabolites in assessment of [18F]PBR-111 as a single positron computed tomography (PET) brain imaging agent.
Time frame: 1 year
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 11 Nov 2013.
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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.
Danna Jennings, 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] PBR111 in people with 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?
The sponsor lists 15 inclusion and 15 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 11 Nov 2013. 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 evaluate the cerebral distribution of [18F]PBR-111 positron emission tomography (PET) for detection/exclusion of microglial activation in patients with Alzheimer Disease compared to healthy volunteers. (time frame: 1 year). 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 11 Nov 2013.