Evaluation of [18F]RO6958948 as Tracer for Positron Emission Tomography (PET) Imaging of Tau Burden in Alzheimer's Disease Participants
NCT ID: NCT02792179
Last Updated: 2017-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
4 participants
INTERVENTIONAL
2016-07-19
2016-09-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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[18F]RO6958948
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).
[18F]RO6958948
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 \[mCi\]).
Interventions
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[18F]RO6958948
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 \[mCi\]).
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
* History of drug or alcohol abuse or positive result from urine screen for drugs of abuse
* 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
25 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Johns Hopkins Medical Institutions, Johns Hopkins Outpatient Center
Baltimore, Maryland, United States
Countries
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Other Identifiers
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BP39126
Identifier Type: -
Identifier Source: org_study_id