Alzheimer's DiseasePhase 1NCT02792179
Evaluation of [18F]RO6958948 as Tracer for Positron Emission Tomography (PET) Imaging of Tau Burden in Alzheimer's Disease Participants
A Phase 1 study testing [18F]RO6958948 in people with Alzheimer's Disease, run by Hoffmann-La Roche at 1 site in United States.
Trial summary
This is a longitudinal, follow-up study in participants with Alzheimer's disease (AD) who previously participated in study BP29409 (NCT02187627). This study is designed to assess the longitudinal change of Tau pathology in the brain of participants with AD using the PET ligand [18F]RO6958948 and to assess the safety… Read more about this study
- Who is it for?
- Ages 25 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- [18F]RO6958948
- 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
- 19 Jul 2016to 28 Sep 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 25 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- AD participants previously scanned with [18F]RO6958948 in Roche Study BP29409
- Agreement to use highly effective contraception measures
- Body mass index (BMI) between 18 and 32 Kilograms per square meter (kg/m^2)
- A study partner able to accompany the participant to all visits and answer questions about the participant
- In the opinion of investigator, based on the medical history and physical examination, can safely tolerate tracer administration and the scanning procedures
- Documented positive visual read (as per local procedures for florbetapir or similar procedures for other amyloid tracers) of an amyloid PET scan, which in the opinion of the principal investigator is consistent with a diagnosis of AD
Who cannot join
- History or presence of any clinically relevant hematological, hepatic, respiratory, cardiovascular, renal, metabolic, endocrine, or central nervous system disease or other medical conditions that are not well controlled, may put the participant at risk, could interfere with the objectives of the study, or make the participant unsuitable for participation in the study for any other reason in the opinion of the principal investigator
- Clinically relevant pathological findings in physical examination, electrocardiogram, or laboratory values at the screening assessment that could impact participant safety
- Known history of clinically significant infectious disease including autoimmune deficiency syndrome (AIDS) or serological indication of acute/chronic hepatitis B or C or Human Immuno Virus infection
- Women of childbearing potential must not be pregnant, or nursing and serum human chorionic gonadotropin (HCG) must be negative at the time of Screening Visit 1, and urine HCG must be negative on all subsequent visits
- Loss or donation of more than 450 milliliters (mL) blood in the 4 months before screening or donation of plasma within 14 days of screening
- Unsuitable veins for repeated venipuncture
Show all 12Show fewer
- History of drug or alcohol abuse or positive result from urine screen for drugs of abuse
- Have received an investigational medication within the last 3 months or 5 times the elimination half-life, whichever is longer, prior to enrollment Exclusion Criteria Related to Trial Procedures
- Has had or is planning to have exposure to ionizing radiation that in combination with the study-related tracer administrations and scanning procedures would result in a cumulative exposure that exceeds the recommended annual exposure limit
- Presence of pacemakers; aneurysm clips; artificial heart valves; ear implants; foreign metal objects in the eyes, skin, or body, or any other circumstance that would contraindicate a magnetic resonance imaging (MRI) scan
- History of, or suffers from, claustrophobia or feels that he or she will be unable to lie still on their back in the MRI or PET scanner
- Has received treatment that targeted amyloid-beta or tau within the last 24 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Medical Institutions, Johns Hopkins Outpatient Center
Baltimore, Maryland, 21287-0807
About this study
Official title: A Pilot Longitudinal Follow-Up Study of Tau Burden in The Brain of Subjects With Alzheimer's Disease Who Previously Participated in Study BP29409 Using [18F]RO6958948 Positron Emission Tomography
This is a longitudinal, follow-up study in participants with Alzheimer's disease (AD) who previously participated in study BP29409 (NCT02187627). This study is designed to assess the longitudinal change of Tau pathology in the brain of participants with AD using the PET ligand [18F]RO6958948 and to assess the safety and tolerability of PET ligand.
- Conditions
- Alzheimer's Disease
- Being tested
- [18F]RO6958948
- 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]RO6958948Drug
Radiolabeled low molecular weight compound, administered as single IV injection. The mass dose of [18F]RO6958948 injected will be less than or equal to (</=) 10 micrograms (µg), injection volume </=20 mL. Target injected activity for [18F]RO6958948 will be 370 megaBecquerel (MBq) (10 millicurie [mCi]).
| Study group | Role | What they receive |
|---|---|---|
| [18F]RO6958948 | Experimental | Each participant will receive a single intravenous (IV) dose of [18F]RO6958948 and a single PET scan approximately 9-24 months after the baseline scan (in Study BP29409). Receives: Drug: [18F]RO6958948 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Regional Standardized Uptake Value (SUV), as Assessed by the tau PET Brain Scan
Measured: Day 1
Regional Standardized Uptake Value Ratios (SUVR), as Assessed by the Tau PET Brain Scan
Measured: Day 1
Change in SUV for Different Brain Regions
Measured: Baseline to approximately 24 months
Change in SUVR for Different Brain Regions
Measured: Baseline to approximately 24 months
Secondary outcomes (1)
Percentage of Participants with Adverse Events
Measured: Screening to 7-14 days after Tau PET scan (Up to approximately 7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study start19 Jul 2016
- Primary completion28 Sep 2016
- Study completion28 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792179
- Sponsor's protocol ID
- BP39126
- Status last verified
- Oct 2017
- First submitted
- 2 Jun 2016
- Last updated
- 1 Nov 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Longitudinal Follow-Up Study of Tau Burden in The Brain of Subjects With Alzheimer's Disease Who Previously Participated in Study BP29409 Using [18F]RO6958948 Positron Emission Tomography
- ClinicalTrials.gov ID
- NCT02792179
- Acronym / sponsor ID
- BP39126
- Conditions
- Alzheimer's Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 19 Jul 2016 (actual)
- Primary completion
- 28 Sep 2016 (actual)
- Study completion
- 28 Sep 2016 (actual)
- First posted
- 7 Jun 2016 (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.
This is a longitudinal, follow-up study in participants with Alzheimer's disease (AD) who previously participated in study BP29409 (NCT02187627). This study is designed to assess the longitudinal change of Tau pathology in the brain of participants with AD using the PET ligand [18F]RO6958948 and to assess the safety and tolerability of PET ligand.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| [18F]RO6958948 | Experimental | Drug: [18F]RO6958948Each participant will receive a single intravenous (IV) dose of [18F]RO6958948 and a single PET scan approximately 9-24 months after the baseline scan (in Study BP29409). |
Who may qualify
- Ages
- 25 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- AD participants previously scanned with [18F]RO6958948 in Roche Study BP29409
- Agreement to use highly effective contraception measures
- Body mass index (BMI) between 18 and 32 Kilograms per square meter (kg/m^2)
- A study partner able to accompany the participant to all visits and answer questions about the participant
- In the opinion of investigator, based on the medical history and physical examination, can safely tolerate tracer administration and the scanning procedures
Key exclusion criteria (12 listed)
- History or presence of any clinically relevant hematological, hepatic, respiratory, cardiovascular, renal, metabolic, endocrine, or central nervous system disease or other medical conditions that are not well controlled, may put the participant at risk, could interfere with the objectives of the study, or make the participant unsuitable for participation in the study for any other reason in the opinion of the principal investigator
- Clinically relevant pathological findings in physical examination, electrocardiogram, or laboratory values at the screening assessment that could impact participant safety
- Known history of clinically significant infectious disease including autoimmune deficiency syndrome (AIDS) or serological indication of acute/chronic hepatitis B or C or Human Immuno Virus infection
- Women of childbearing potential must not be pregnant, or nursing and serum human chorionic gonadotropin (HCG) must be negative at the time of Screening Visit 1, and urine HCG must be negative on all subsequent visits
- Loss or donation of more than 450 milliliters (mL) blood in the 4 months before screening or donation of plasma within 14 days of screening
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]RO6958948Radiolabeled low molecular weight compound, administered as single IV injection. The mass dose of [18F]RO6958948 injected will be less than or equal to (</=) 10 micrograms (µg), injection volume </=20 mL. Target injected activity for [18F]RO6958948 will be 370 megaBecquerel (MBq) (10 millicurie [mCi]). | Drug | [18F]RO6958948 |
Primary outcome
Regional Standardized Uptake Value (SUV), as Assessed by the tau PET Brain Scan
Time frame: Day 1
Regional Standardized Uptake Value Ratios (SUVR), as Assessed by the Tau PET Brain Scan
Time frame: Day 1
Change in SUV for Different Brain Regions
Time frame: Baseline to approximately 24 months
Change in SUVR for Different Brain Regions
Time frame: Baseline to approximately 24 months
1 secondary outcome
Percentage of Participants with Adverse Events
Time frame: Screening to 7-14 days after Tau PET scan (Up to approximately 7 weeks)
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 1 Nov 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.
Clinical Trials study director
Hoffmann-La Roche
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]RO6958948 in people with Alzheimer's Disease, run by Hoffmann-La Roche 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 6 inclusion and 12 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 1 Nov 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?
Regional Standardized Uptake Value (SUV), as Assessed by the tau PET Brain Scan (time frame: Day 1). The study lists 4 primary outcomes in all. 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 1 Nov 2017.