DementiaPhase 3NCT01886820
A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology
A Phase 3 study testing [18F]NAV4694 in people with Dementia and Alzheimer's Disease, run by Navidea Biopharmaceuticals at 15 sites in United States.
Trial summary
To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Dementia, Alzheimer's Disease
- What is being tested?
- [18F]NAV4694
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 290 participants
- Where
- 15 sitesUnited States
- Study dates
- Jun 2013to Sep 2018
- Phase
- Phase 3
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects will be at least 21 years of age.
- Subjects will have a life expectancy of approximately 6 months
- Subject health is adequate as determined by the investigator to receive [18F]NAV4694
- Female subjects will not be of child-bearing potential or will have a negative urine pregnancy test on day of [18F]NAV4694 injection.
- Must exhibit adequate visual, auditory, and communication capabilities to enable compliance with study procedures. This includes being able to lie down flat in the MRI or CT and PET scanner for a period of approximately 1 hour.
- Subjects must be willing to donate their brains for post mortem examination upon death (this consent can be obtained in the manner specific to the country/region involved).
- Subjects have been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative (LAR) (for individuals with dementia).
Who cannot join
- Scheduled for surgery and/or another invasive procedure within the time period of up to 7 days after [18F]NAV4694 injection.
- Has severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by MRI that prohibits sampling of the required pre-specified ROIs.
- Has any history of any transmissible spongiform encephalopathy (prion disease).
- Has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131-I) within 10 days prior to, or any radiopharmaceutical administration within 10 radioactive half-lives prior to the administration of the investigational product or for whom administration of such substances is planned within 7 days after investigational product administration.
- Is allergic to the investigational product or any of its constituents.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Valley Medical Center
Centerville, Ohio, 45459
The University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27559
Rush University Medical Center
Chicago, Illinois, 60612
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, 33912
University of California San Diego
La Jolla, California, 92093
Las Vegas Radiology
Las Vegas, Nevada, 89113
Mount Sinai Medical Center of Florida
Miami Beach, Florida, 33140
Galiz Research
Miami Springs, Florida, 33166
Compass Research
Orlando, Florida, 32806
Physicians Care Clinical Research
Sarasota, Florida, 34239
Biomedical Research Foundation
Shreveport, Louisiana, 71103
Southern Illinois University School of Medicine
Springfield, Illinois, 62702
Banner Sun Health Research Institute
Sun City, Arizona, 85351
Albert Einstein College of Medicine
The Bronx, New York, 10461
Wake Forest Baptist Health-Gerontology
Winston-Salem, North Carolina, 27157
About this study
To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology
- Conditions
- Dementia, Alzheimer's Disease
- Being tested
- [18F]NAV4694
- Keywords
- Dementia, Alzheimer's Disease, Terminally Ill
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[18F]NAV4694Drug
| Study group | Role | What they receive |
|---|---|---|
| [18F]NAV4694 | Experimental | Intravenous [18F]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once Receives: Drug: [18F]NAV4694 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology
Measured: 6 Months
Secondary outcomes (4)
Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology
Measured: 6 Months
Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology
Measured: 6 Months
Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology
Measured: 6 Months
Incidence of adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2018 (estimated)
- Study completionSep 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 290 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Navidea Biopharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cornelia Reininger, MD PhD, Study director, Navidea Biopharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01886820
- Sponsor's protocol ID
- NAV4-02
- Status last verified
- Jul 2017
- First submitted
- 24 Jun 2013
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology
- ClinicalTrials.gov ID
- NCT01886820
- Acronym / sponsor ID
- NAV4-02
- Conditions
- Dementia, Alzheimer's Disease
- Keywords
- Dementia, Alzheimer's Disease, Terminally Ill
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 290 participants (estimated)
- Lead sponsor
- Navidea BiopharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2013 (actual)
- Primary completion
- Jun 2018 (estimated)
- Study completion
- Sep 2018 (estimated)
- First posted
- 26 Jun 2013 (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.
To Determine the the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral β-Amyloid When Compared With Postmortem Histopathology
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]NAV4694 | Experimental | Drug: [18F]NAV4694Intravenous [18F]NAV4694 radioactive dose 8.1 mCi(300 MBq) given once |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female subjects will be at least 21 years of age.
- Subjects will have a life expectancy of approximately 6 months
- Subject health is adequate as determined by the investigator to receive [18F]NAV4694
- Female subjects will not be of child-bearing potential or will have a negative urine pregnancy test on day of [18F]NAV4694 injection.
- Must exhibit adequate visual, auditory, and communication capabilities to enable compliance with study procedures. This includes being able to lie down flat in the MRI or CT and PET scanner for a period of approximately 1 hour.
Key exclusion criteria (5 listed)
- Scheduled for surgery and/or another invasive procedure within the time period of up to 7 days after [18F]NAV4694 injection.
- Has severe cerebral macrovascular (i.e., multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by MRI that prohibits sampling of the required pre-specified ROIs.
- Has any history of any transmissible spongiform encephalopathy (prion disease).
- Has received any contrast material (X-ray, MRI) or radiopharmaceutical within 48 hours prior to, or a therapeutic radiopharmaceutical (e.g., 131-I) within 10 days prior to, or any radiopharmaceutical administration within 10 radioactive half-lives prior to the administration of the investigational product or for whom administration of such substances is planned within 7 days after investigational product administration.
- Is allergic to the investigational product or any of its constituents.
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]NAV4694 | Drug | [18F]NAV4694 |
Primary outcome
Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology
Time frame: 6 Months
4 secondary outcomes
Quantification of [18F]NAV4694 brain PET Scan positivity compared to histopathology
Time frame: 6 Months
Incidence of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology
Time frame: 6 Months
Quantification of [18F]NAV4694 PET Scan positivity in 6 pre-specified brain regions compared to histopathology
Time frame: 6 Months
Incidence of adverse events
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 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.
Cornelia Reininger, MD PhD study director
Navidea Biopharmaceuticals
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing [18F]NAV4694 in people with Dementia and Alzheimer's Disease, run by Navidea Biopharmaceuticals at 15 sites 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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Incidence of [18F]NAV4694 Brain PET scan positivity compared to histopathology (time frame: 6 Months). 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 26 Jul 2017.