HealthyNCT03939780
Tau Tracer Comparison in Healthy Controls and Alzheimer's Disease Patients
A study testing [F18]RO-948, [F18]MK-6240 and [F18]AV1451 in people with Healthy and Alzheimer Disease, run by Johns Hopkins University at 1 site in United States.
Trial summary
The primary objective of this study is to identify a new radioligand for imaging of tauopathy in Alzheimer's disease through direct comparisons of two potential candidates, [18F]RO-948 (formerly known as [18F]6958948) and [18F]MK-6240, and demonstration of the candidates' absence of off-target binding. Read more about this study
- Who is it for?
- Ages 50 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Alzheimer Disease
- What is being tested?
- [F18]RO-948, [F18]MK-6240 and [F18]AV1451
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2020to Apr 2023
- Phase
- Interventional
- 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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male and female subjects 50 to 100 years of age
- Female subjects must be either surgically sterile or post-menopausal for at least 1 year or,
- Women of child bearing potential must commit to use a barrier contraception method for the duration of the study in addition to either an intra uterine device or hormonal contraception started at least 1 month prior to the first dose of radiotracer and until follow-up.
- Male subjects and their partners of childbearing potential must agree to use an effective method of contraception and will not donate sperm during the study. Barrier method must include use of a spermicide.
- Subjects who sign an IRB approved informed consent prior to any study procedures. Subjects deemed incapable of informed consent must provide assent and informed consent provided by, a legally authorized representative.
- Subjects who in the opinion of the investigator based on medical history and physical exam can tolerate the PET scan procedures.
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- If subjects are on any concomitant medication, the indication and dosage of these medicines should be stable for at least 4 weeks prior to study start with the expectation that no relevant changes in use or dose will occur throughout the trial.
- Body mass index BMI between 18 and 32 kg per m2, Body weight less than 300 pounds.
- Normal cognitive function, including a normal Mini-Mental State Exam (MMSE) (>28) score as judged by the investigator for Control Subjects.
- Inclusion Criteria for Subjects with a Diagnosis of Probable Alzheimer's disease
- Capacity for consent will be determined using the Alzheimer's Association Guidelines, developed at Johns Hopkins and described in Alzheimer's Association Consensus Recommendation Research consent for cognitively impaired adults Guidelines for Institutional Review Boards and Investigators Alzheimer's Association 2004.
- Have a reliable study partner able to accompany the subject to all visits and answer questions about the subject.
- Have a diagnosis of probable AD, according to the National Institute of Neurological and Communicative Disorders and Stroke Alzheimer's Disease and Related Disorders Association criteria
- MMSE score of between 16 and 26, inclusive.
- In the opinion of the investigator based on medical history and physical examination, can safely tolerate tracer administration and the scanning procedures.
- A positive visual read as per local procedures for florbetapir or similar procedures for other amyloid tracers of an amyloid PET scan, or amyloid-beta and tau cerebrospinal fluid (CSF) levels, which in the opinion of the principal investigator is consistent with a diagnosis of AD.
Who cannot join
- History or presence of a neurological diagnosis other than AD that may influence the outcome or analysis of the scan results examples include but are not limited to stroke, traumatic brain injury, space occupying lesions, non-Alzheimer's tauopathies, and Parkinson's disease.
- Subjects with a medical history that includes known autosomal dominant AD mutations in amyloid precursor protein (APP) or presenilin (PS) 1, PS 2 or mutations in genes that cause other types of autosomal dominant familial dementia, e.g., microtubule-associated protein tau (MAPT)
- History or presence of any clinically relevant hematological, hepatic, respiratory, cardiovascular, renal, metabolic, endocrine, or central nervous system (CNS) disease or other medical conditions that are not well controlled, may put the subject at risk, could interfere with the objectives of the study, or make the subject unsuitable for participation in the study for any other reason in the opinion of the principal investigator.
- Clinically relevant pathological findings in physical examination, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the study.
- Known history of clinically significant infectious disease including AIDS or serological indication of acute or chronic hepatitis B or C or HIV 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, and urine HCG must be negative on all subsequent visits.
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- Loss or donation of more than 450 mL blood in the 4 months before screening or donation of plasma within 14 days of screening.
- Current symptoms of allergy and or severe allergy to drugs in medical history.
- History of drug or alcohol abuse or positive result from urine screen for drugs of abuse AD subjects on prescribed narcotics medications will not be excluded if urine drug screen is positive for the documented narcotic drugs.
- Have received an investigational medication within the last 3 months or 5 elimination half-life, whichever is longer, prior to administration of the radiotracer.
- 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 recommended exposure limits.
- Contraindications of MRI
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of [18F]RO-948, [18F]MK-6240, and [18F]AV-1451 TAU Radiopharmaceuticals in Patients With Alzheimer's Disease and Older Controls
The primary objective of this study is to identify a new radioligand for imaging of tauopathy in Alzheimer's disease through direct comparisons of two potential candidates, [18F]RO-948 (formerly known as [18F]6958948) and [18F]MK-6240, and demonstration of the candidates' absence of off-target binding.
Read the detailed description
This is an open label study to compare two new generation TAU radioligands, [18F]RO-948 (formerly known as [18F]6958948) and [18F]MK-6240, for imaging of tauopathy and demonstrate the radioligands' absence of off-target binding in patients with Alzheimer's disease (AD) and older healthy controls (OC). The study will directly compare AD and OC with these two next-generation TAU radio ligands and compare each of these radio ligands with the current most widely used first generation radioligand, [18F]AV-1451.
Up to 24 (12 AD and 12 OC, matched for age and sex with AD subjects) male and female subjects aged 50-100 will be enrolled in the study. The study consists of three cohorts.
- Cohort 1: 10 AD subjects and 10 aged and sex matched older controls will be enrolled. Subjects will be scanned twice, with each of the tracers [18F]RO-948 and [18F]MK-6240.
- Cohort 2A: No positron emission tomography (PET) scans will be done. Previous [18F]AV-1451 scans of selected aged matched OC subjects from the Baltimore Longitudinal Study of Aging (BLSA) study (IRB00047185) will be reanalyzed.
- Cohort 2B: 2 AD and 2 OC subjects who show high binding to the choroid plexus by a visual analog scale (high, low, and none) will be studied. Subjects will scanned twice with either: [18F]RO-948 or [18F]MK-6240 and a 2nd scan with [18F]AV-1451 in randomized order and within one month of each other.
- Conditions
- Healthy, Alzheimer Disease
- Being tested
- [F18]RO-948, [F18]MK-6240, [F18]AV1451
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[F18]RO-948Diagnostic test
Single radiotracer IV injection with subsequent emission scan
[F18]MK-6240Diagnostic test
Single radiotracer IV injection with subsequent emission scan
[F18]AV1451Diagnostic test
Single radiotracer IV injection with subsequent emission scan
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Experimental | Subjects will be scanned twice (once with each of the tracers [18F]RO-948 and [18F]MK-6240) Receives: Diagnostic Test: [F18]RO-948; Diagnostic Test: [F18]MK-6240 |
| Cohort 2A | No intervention | No PET scans will be done. Previous [18F]AV-1451 scans of selected aged matched older cognitively healthy controls (OC) subjects from the Baltimore Longitudinal Study of Aging (BLSA) study (IRB00047185) will be reanalyzed. |
| Cohort 2B1 - AD [18F]RO-948 and [18F]AV-1451 | Experimental | Alzheimer's Disease (AD) subjects who show high binding to the choroid plexus by a visual analog scale (high, low, and none) will be studied. Subjects with AD will be scanned twice: once with [18F]RO-948 and a second scan with [18F]AV-1451 in randomized order and within one month of each other. Receives: Diagnostic Test: [F18]RO-948; Diagnostic Test: [F18]AV1451 |
| Cohort 2B2 - AD [18F]MK-6240 and [18F]AV-1451 | Experimental | AD subjects who show high binding to the choroid plexus by a visual analog scale (high, low, and none) will be studied. Subjects with AD will be scanned twice: once with [18F]MK-6240 and a second scan with [18F]AV-1451 in randomized order and within one month of each other. Receives: Diagnostic Test: [F18]MK-6240; Diagnostic Test: [F18]AV1451 |
| Cohort 2B3 - OC [18F]RO-948 and [18F]AV-1451 | Experimental | OC subjects who show high binding to the choroid plexus by a visual analog scale (high, low, and none) will be studied. Subjects with OC will be scanned twice: once with [18F]RO-948 and a second scan with [18F]AV-1451 in randomized order and within one month of each other. Receives: Diagnostic Test: [F18]RO-948; Diagnostic Test: [F18]AV1451 |
| Cohort 2B4 - OC [18F]MK-6240 and [18F]AV-1451 | Experimental | OC subjects who show high binding to the choroid plexus by a visual analog scale (high, low, and none) will be studied. Subjects with OC will be scanned twice: once with [18F]MK-6240 and a second scan with [18F]AV-1451 in randomized order and within one month of each other. Receives: Diagnostic Test: [F18]MK-6240; Diagnostic Test: [F18]AV1451 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tracer kinetics as measured by distribution volume of radioligands
Distribution volume (Vt) of the two newer radioligands, RO-948 and MK-6240, in older cognitively-normal control subjects (OC) and in clinically diagnosed Alzheimer's Disease (AD) patients.
Measured: 3 years
Tracer kinetics as measured by Standard Uptake Volume Ratio of radioligands
Standard Uptake Volume Ratio (SUVR) of the two newer radioligands, RO-948 and MK-6240, in the OC and AD patients.
Measured: 3 years
Tracer kinetics as measured by distribution volume of radioligands in off-target binding regions
Distribution volume (Vt) of the two newer radioligands, RO-948 and MK-6240, in older cognitively-normal control subjects (OC) and in clinically diagnosed Alzheimer's Disease (AD) patients in the off-target binding regions (basal ganglia, thalamus and choroid plexus).
Measured: 3 years
Tracer kinetics as measured by SUVR of radioligands in off-target binding regions
SUVR of the two newer radioligands, RO-948 and MK-6240, in older cognitively-normal control subjects (OC) and in clinically diagnosed Alzheimer's Disease (AD) patients in the off-target binding regions (basal ganglia, thalamus and choroid plexus).
Measured: 3 years
Secondary outcomes (4)
Tracer kinetics as measured by distribution volume of radioligands in participants with high binding of AV-1541
Distribution volume (Vt) of the two newer radioligands, RO-948 and MK-6240, in participants with confirmed high-binding of AV-1541 in choroid plexus
Measured: 3 years
Tracer kinetics as measured by SUVR of radioligands in participants with high binding of AV-1541
SUVR of the two newer radioligands, RO-948 and MK-6240, in participants with confirmed high-binding of AV-1541 in choroid plexus
Measured: 3 years
Tracer kinetics as measured by volume distribution of radioligands in the hippocampus
Distribution volume (Vt) of the two newer radioligands, RO-948 and MK-6240, in older cognitively-normal control subjects (OC) and in clinically diagnosed Alzheimer's Disease (AD) patients in the hippocampus.
Measured: 3 years
Tracer kinetics as measured by SUVR of radioligands in the hippocampus
SUVR of the two newer radioligands, RO-948 and MK-6240, in older cognitively-normal control subjects (OC) and in clinically diagnosed Alzheimer's Disease (AD) patients in the hippocampus.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study startJan 2020 (estimated)
- Primary completionApr 2023 (estimated)
- Study completionApr 2023 (estimated)
Why it stopped: PI moving to another institution with NIH grant relinquished.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Dean Wong, MD/PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939780
- Sponsor's protocol ID
- IRB00193649
- Other IDs
- 1R21AG062314-01
- Status last verified
- Feb 2020
- First submitted
- 3 May 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of [18F]RO-948, [18F]MK-6240, and [18F]AV-1451 TAU Radiopharmaceuticals in Patients With Alzheimer's Disease and Older Controls
- ClinicalTrials.gov ID
- NCT03939780
- Acronym / sponsor ID
- IRB00193649
- Conditions
- Healthy, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI moving to another institution with NIH grant relinquished.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Jan 2020 (estimated)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Apr 2023 (estimated)
- First posted
- 7 May 2019 (actual)
- 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 primary objective of this study is to identify a new radioligand for imaging of tauopathy in Alzheimer's disease through direct comparisons of two potential candidates, [18F]RO-948 (formerly known as [18F]6958948) and [18F]MK-6240, and demonstration of the candidates' absence of off-target binding.
Detailed description
This is an open label study to compare two new generation TAU radioligands, [18F]RO-948 (formerly known as [18F]6958948) and [18F]MK-6240, for imaging of tauopathy and demonstrate the radioligands' absence of off-target binding in patients with Alzheimer's disease (AD) and older healthy controls (OC). The study will directly compare AD and OC with these two next-generation TAU radio ligands and compare each of these radio ligands with the current most widely used first generation radioligand, [18F]AV-1451.
Up to 24 (12 AD and 12 OC, matched for age and sex with AD subjects) male and female subjects aged 50-100 will be enrolled in the study. The study consists of three cohorts.
- Cohort 1: 10 AD subjects and 10 aged and sex matched older controls will be enrolled. Subjects will be scanned twice, with each of the tracers [18F]RO-948 and [18F]MK-6240.
- Cohort 2A: No positron emission tomography (PET) scans will be done. Previous [18F]AV-1451 scans of selected aged matched OC subjects from the Baltimore Longitudinal Study of Aging (BLSA) study (IRB00047185) will be reanalyzed.
- Cohort 2B: 2 AD and 2 OC subjects who show high binding to the choroid plexus by a visual analog scale (high, low, and none) will be studied. Subjects will scanned twice with either: [18F]RO-948 or [18F]MK-6240 and a 2nd scan with [18F]AV-1451 in randomized order and within one month of each other.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Experimental | Diagnostic Test: [F18]RO-948, Diagnostic Test: [F18]MK-6240Subjects will be scanned twice (once with each of the tracers [18F]RO-948 and [18F]MK-6240) |
| Cohort 2A | No intervention | –No PET scans will be done. Previous [18F]AV-1451 scans of selected aged matched older cognitively healthy controls (OC) subjects from the Baltimore Longitudinal Study of Aging (BLSA) study (IRB00047185) will be reanalyzed. |
| Cohort 2B1 - AD [18F]RO-948 and [18F]AV-1451 | Experimental | Diagnostic Test: [F18]RO-948, Diagnostic Test: [F18]AV1451Alzheimer's Disease (AD) subjects who show high binding to the choroid plexus by a visual analog scale (high, low, and none) will be studied. Subjects with AD will be scanned twice: once with [18F]RO-948 and a second scan with [18F]AV-1451 in randomized order and within one month of each other. |
| Cohort 2B2 - AD [18F]MK-6240 and [18F]AV-1451 | Experimental | Diagnostic Test: [F18]MK-6240, Diagnostic Test: [F18]AV1451AD subjects who show high binding to the choroid plexus by a visual analog scale (high, low, and none) will be studied. Subjects with AD will be scanned twice: once with [18F]MK-6240 and a second scan with [18F]AV-1451 in randomized order and within one month of each other. |
| Cohort 2B3 - OC [18F]RO-948 and [18F]AV-1451 | Experimental | Diagnostic Test: [F18]RO-948, Diagnostic Test: [F18]AV1451OC subjects who show high binding to the choroid plexus by a visual analog scale (high, low, and none) will be studied. Subjects with OC will be scanned twice: once with [18F]RO-948 and a second scan with [18F]AV-1451 in randomized order and within one month of each other. |
| Cohort 2B4 - OC [18F]MK-6240 and [18F]AV-1451 | Experimental | Diagnostic Test: [F18]MK-6240, Diagnostic Test: [F18]AV1451OC subjects who show high binding to the choroid plexus by a visual analog scale (high, low, and none) will be studied. Subjects with OC will be scanned twice: once with [18F]MK-6240 and a second scan with [18F]AV-1451 in randomized order and within one month of each other. |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Male and female subjects 50 to 100 years of age
- Female subjects must be either surgically sterile or post-menopausal for at least 1 year or,
- Women of child bearing potential must commit to use a barrier contraception method for the duration of the study in addition to either an intra uterine device or hormonal contraception started at least 1 month prior to the first dose of radiotracer and until follow-up.
- Male subjects and their partners of childbearing potential must agree to use an effective method of contraception and will not donate sperm during the study. Barrier method must include use of a spermicide.
- Subjects who sign an IRB approved informed consent prior to any study procedures. Subjects deemed incapable of informed consent must provide assent and informed consent provided by, a legally authorized representative.
Key exclusion criteria (13 listed)
- History or presence of a neurological diagnosis other than AD that may influence the outcome or analysis of the scan results examples include but are not limited to stroke, traumatic brain injury, space occupying lesions, non-Alzheimer's tauopathies, and Parkinson's disease.
- Subjects with a medical history that includes known autosomal dominant AD mutations in amyloid precursor protein (APP) or presenilin (PS) 1, PS 2 or mutations in genes that cause other types of autosomal dominant familial dementia, e.g., microtubule-associated protein tau (MAPT)
- History or presence of any clinically relevant hematological, hepatic, respiratory, cardiovascular, renal, metabolic, endocrine, or central nervous system (CNS) disease or other medical conditions that are not well controlled, may put the subject at risk, could interfere with the objectives of the study, or make the subject unsuitable for participation in the study for any other reason in the opinion of the principal investigator.
- Clinically relevant pathological findings in physical examination, ECG, or laboratory values at the screening assessment that could interfere with the objectives of the study.
- Known history of clinically significant infectious disease including AIDS or serological indication of acute or chronic hepatitis B or C or HIV infection.
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 |
|---|---|---|
| [F18]RO-948Single radiotracer IV injection with subsequent emission scan | Diagnostic test | Cohort 1, Cohort 2B1 - AD [18F]RO-948 and [18F]AV-1451, Cohort 2B3 - OC [18F]RO-948 and [18F]AV-1451 |
| [F18]MK-6240Single radiotracer IV injection with subsequent emission scan | Diagnostic test | Cohort 1, Cohort 2B2 - AD [18F]MK-6240 and [18F]AV-1451, Cohort 2B4 - OC [18F]MK-6240 and [18F]AV-1451 |
| [F18]AV1451Single radiotracer IV injection with subsequent emission scan | Diagnostic test | Cohort 2B1 - AD [18F]RO-948 and [18F]AV-1451, Cohort 2B2 - AD [18F]MK-6240 and [18F]AV-1451, Cohort 2B3 - OC [18F]RO-948 and [18F]AV-1451, Cohort 2B4 - OC [18F]MK-6240 and [18F]AV-1451 |
Primary outcome
Tracer kinetics as measured by distribution volume of radioligands
Time frame: 3 years
Distribution volume (Vt) of the two newer radioligands, RO-948 and MK-6240, in older cognitively-normal control subjects (OC) and in clinically diagnosed Alzheimer's Disease (AD) patients.
Tracer kinetics as measured by Standard Uptake Volume Ratio of radioligands
Time frame: 3 years
Standard Uptake Volume Ratio (SUVR) of the two newer radioligands, RO-948 and MK-6240, in the OC and AD patients.
Tracer kinetics as measured by distribution volume of radioligands in off-target binding regions
Time frame: 3 years
Distribution volume (Vt) of the two newer radioligands, RO-948 and MK-6240, in older cognitively-normal control subjects (OC) and in clinically diagnosed Alzheimer's Disease (AD) patients in the off-target binding regions (basal ganglia, thalamus and choroid plexus).
Tracer kinetics as measured by SUVR of radioligands in off-target binding regions
Time frame: 3 years
SUVR of the two newer radioligands, RO-948 and MK-6240, in older cognitively-normal control subjects (OC) and in clinically diagnosed Alzheimer's Disease (AD) patients in the off-target binding regions (basal ganglia, thalamus and choroid plexus).
4 secondary outcomes
Tracer kinetics as measured by distribution volume of radioligands in participants with high binding of AV-1541
Time frame: 3 years
Tracer kinetics as measured by SUVR of radioligands in participants with high binding of AV-1541
Time frame: 3 years
Tracer kinetics as measured by volume distribution of radioligands in the hippocampus
Time frame: 3 years
Tracer kinetics as measured by SUVR of radioligands in the hippocampus
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Dean Wong, MD/PhD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing [F18]RO-948, [F18]MK-6240 and [F18]AV1451 in people with Healthy and Alzheimer Disease, run by Johns Hopkins University 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 16 inclusion and 13 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: withdrawn, as of the sponsor's last update on 11 Feb 2020. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Tracer kinetics as measured by distribution volume of radioligands (time frame: 3 years). 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 11 Feb 2020.