Diagnostic ImagingPhase 1NCT01009359
Evaluation of the Neuroinflammation Pattern of BAY85-8102 F-18, DPA-714 in Probable Alzheimers Disease Patients Versus Healthy Volunteers and Radiation Dosimetry of F 18, DPA-714 in Healthy Volunteers
A Phase 1 study testing F-18 DPA-714 (BAY85-8102) in people with Diagnostic Imaging, run by Bayer at 2 sites in 2 countries.
Trial summary
PET (positron emission tomography) imaging with BAY85-8102 F-18, DPA-714 for investigation of neuroinflammation pattern in probable Alzheimers patients versus healthy volunteers and radiation dosimetry in healthy volunteer. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Imaging
- What is being tested?
- F-18 DPA-714 (BAY85-8102)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2009to Oct 2010
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to give fully informed consent in writing
- Males or females aged >/= 50 years
- No significant disease or drug use
- Absence of any sign of dementia/cognitive impairment in neuropsychological examinationsPatients for brain imaging:
- Patient and designee capable of giving fully informed consent in writing
- Patient fulfils DSM-IV and NINCDS-ADRA criteria for probable Alzheimers disease
- Patient has undergone physical and neurological examination, ECG and test of routine hematological and biochemical parameters prior to radiotracer administration Exclusion Criteria:- Pregnancy or lactation
- Current unstable medical condition (e.g. unstable angina, myocardial infarction or coronary revascularization in the preceding 12 months, cardiac failure, chronic renal failure, chronic hepatic disease, severe pulmonary disease, blood disorders, poorly controlled diabetes, chronic infection)
Who cannot join
None listed.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Open-label, Non-randomized, Multicenter Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 250 MBq BAY85-8102 F-18, DPA-714 for Its Diagnostic Potential in Discriminating Patients With Probable Alzheimers Disease From Healthy Volunteers and to Evaluate the Radiation Dosimetry of a Single Dose of 150 MBq BAY858102 F-18, DPA-714 in Healthy Volunteers.
PET (positron emission tomography) imaging with BAY85-8102 F-18, DPA-714 for investigation of neuroinflammation pattern in probable Alzheimers patients versus healthy volunteers and radiation dosimetry in healthy volunteer.
- Conditions
- Diagnostic Imaging
- Being tested
- F-18 DPA-714 (BAY85-8102)
- Keywords
- Alzheimers disease, Diagnostic imaging, PET/CT diagnosis, PET tracer
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-18 DPA-714 (BAY85-8102)Drug
Alzheimer Disease patients: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT
F-18 DPA-714 (BAY85-8102)Drug
Healthy volunteers for brain imaging: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT
F-18 DPA-714 (BAY85-8102)Drug
Healthy volunteers for whole body imaging: Single intervenous bolus injection of 150 MBq BAY85-8102, whole body PET/CT for evaluation of effective dose, kinetics of BAY85-8102 in blood
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: F-18 DPA-714 (BAY85-8102) |
| Arm 2 | Experimental | Not described Receives: Drug: F-18 DPA-714 (BAY85-8102) |
| Arm 3 | Experimental | Not described Receives: Drug: F-18 DPA-714 (BAY85-8102) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by different quantification approaches
Measured: Day of Study tracer administration
Secondary outcomes (7)
Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by visual analysis and standard parameters(e.g. Standardized Uptake Values = SUV)
Measured: Day of Study tracer administration
Electrocardiogram (ECG)
Measured: At least once within 8 days after treatment
Blood pressure
Measured: At least 2 times within 8 days after treatment
Serum protein
Measured: At least once within 8 days after treatment
Serum creatinine
Measured: At least once within 8 days after treatment
Serum GOT (Glutamat-Oxalacetate-Transaminase)
Measured: At least once within 8 days after treatment
Adverse events collection
Measured: Continuously and for a maximum of 28 days after end of observation phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startOct 2009
- Primary completionJul 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic ImagingStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009359
- Sponsor's protocol ID
- 13150
- Other IDs
- 2009-009358-26, 2009
- Status last verified
- Jul 2013
- First submitted
- 5 Nov 2009
- Last updated
- 31 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label, Non-randomized, Multicenter Positron Emission Tomography (PET) Imaging Study to Evaluate a Single Dose of 250 MBq BAY85-8102 F-18, DPA-714 for Its Diagnostic Potential in Discriminating Patients With Probable Alzheimers Disease From Healthy Volunteers and to Evaluate the Radiation Dosimetry of a Single Dose of 150 MBq BAY858102 F-18, DPA-714 in Healthy Volunteers.
- ClinicalTrials.gov ID
- NCT01009359
- Acronym / sponsor ID
- 13150
- Conditions
- Diagnostic Imaging
- Keywords
- Alzheimers disease, Diagnostic imaging, PET/CT diagnosis, PET tracer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 6 Nov 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.
PET (positron emission tomography) imaging with BAY85-8102 F-18, DPA-714 for investigation of neuroinflammation pattern in probable Alzheimers patients versus healthy volunteers and radiation dosimetry in healthy volunteer.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: F-18 DPA-714 (BAY85-8102) |
| Arm 2 | Experimental | Drug: F-18 DPA-714 (BAY85-8102) |
| Arm 3 | Experimental | Drug: F-18 DPA-714 (BAY85-8102) |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Able to give fully informed consent in writing
- Males or females aged >/= 50 years
- No significant disease or drug use
- Absence of any sign of dementia/cognitive impairment in neuropsychological examinationsPatients for brain imaging:
- Patient and designee capable of giving fully informed consent in writing
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| F-18 DPA-714 (BAY85-8102)Alzheimer Disease patients: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT | Drug | Arm 1 |
| F-18 DPA-714 (BAY85-8102)Healthy volunteers for brain imaging: Single intervenous bolus injection of 250 MBq BAY85-8102 on day one of the treatment period, PET/CT | Drug | Arm 2 |
| F-18 DPA-714 (BAY85-8102)Healthy volunteers for whole body imaging: Single intervenous bolus injection of 150 MBq BAY85-8102, whole body PET/CT for evaluation of effective dose, kinetics of BAY85-8102 in blood | Drug | Arm 3 |
Primary outcome
Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by different quantification approaches
Time frame: Day of Study tracer administration
7 secondary outcomes
Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by visual analysis and standard parameters(e.g. Standardized Uptake Values = SUV)
Time frame: Day of Study tracer administration
Electrocardiogram (ECG)
Time frame: At least once within 8 days after treatment
Blood pressure
Time frame: At least 2 times within 8 days after treatment
Serum protein
Time frame: At least once within 8 days after treatment
Serum creatinine
Time frame: At least once within 8 days after treatment
Serum GOT (Glutamat-Oxalacetate-Transaminase)
Time frame: At least once within 8 days after treatment
Adverse events collection
Time frame: Continuously and for a maximum of 28 days after end of observation phase
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 31 Jul 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.
Bayer Study Director study director
Bayer
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing F-18 DPA-714 (BAY85-8102) in people with Diagnostic Imaging, run by Bayer at 2 sites in 2 countries.
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 8 inclusion and 0 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 31 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Netherlands. 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?
Discrimination of probable Alzhemimer disease patients from healthy volunteers by BAY85-81 F-18, DPA-714 brain PET imaging as evaluated by different quantification approaches (time frame: Day of Study tracer administration). 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 31 Jul 2013.