- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02187627
Evaluation of [11C]RO6924963, [11C]RO6931643, and [18F]RO6958948 as Tracers for Positron Emission Tomography (PET) Imaging of Tau in Healthy and Alzheimer's Disease (AD) Participants
December 28, 2018 updated by: Hoffmann-La Roche
Evaluation of [11C]RO6924963, [11C]RO6931643, and [18F]RO6958948 as Tracers for Tau Imaging With Positron Emission Tomography in Healthy Control Subjects and Subjects With Alzheimer's Disease
This study is designed to obtain basic information on three PET imaging tracers developed to detect tau pathology in the brain.
In this study, healthy control participants and participants with AD will be studied.
Information collected will include brain and plasma kinetics, tissue distribution (in the brain), radiation dosimetry, and test-retest variability of the signal in the brain.
The study will consist of Part 1, Part 2A, and Part 2B.
During Part 1, imaging data will be assessed on an ongoing basis and based on data, one tracer will be prioritized over the other two tracers.
The tracer selected will be further investigated in Part 2A and Part 2B.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
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Baltimore, Maryland, United States, 21225
- Parexel International; Harbor Hospital Center
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Baltimore, Maryland, United States, 21287
- Johns Hopkins Universtiy; Radiology Dept
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Inclusion Criteria for All Participants
- Agreement to use highly effective contraception measures
- If participants 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 study
- Body mass index (BMI) between 18 and 32 kilograms per square meter (kg/m^2)
- Weight less than or equal to (</=) 300 pounds (lb)
Inclusion Criteria for Healthy Control Participants
- Healthy "young" control participants aged 25-40 years or healthy "elderly" control participants aged greater than or equal to (>/=) 50 years
- Normal cognitive function, including a normal Mini Mental State Examination (MMSE) score as judged by the investigator
- Healthy control participants who participate in Part 2B: must be less than (<) 195 centimeter (cm) (6 feet, 5 inches) tall in order to accommodate the whole body scanning
Inclusion Criteria for Participants with a Diagnosis of Probable AD
- Diagnosis of probable AD, according to the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria
- Participants aged >/= 50 years
- A study partner able to accompany the participant to all visits and answer questions about the participant
- MMSE score between 16 and 26, inclusive
Exclusion Criteria:
Exclusion Criteria for All Participants
- 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
- Participants with a medical history that includes known autosomal dominant AD mutations in amyloid precursor protein (APP) or presenilin (PS1, PS2) or mutations in genes that cause other types of autosomal dominant familial dementia
- 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 interfere with the objectives of the study
- Known history of clinically significant infectious disease including acquired immunodeficiency syndrome (AIDS) or serological indication of acute/chronic hepatitis B or C or human immunodeficiency virus infection
- Pregnancy or lactation
- Unsuitable veins for repeated venipuncture
- Current symptoms of allergy and/or severe allergy to drugs in medical history
- Alcohol consumption that averages >3 drinks daily or regular smoker (>10 cigarettes, >3 pipefuls, or >3 cigars per day)
- Coffee (or tea) consumption >10 cups per day or methylxanthine-containing drinks >1.5 liters per day (L/day)
- Have received an investigational medication within the last 3 months or 5 times (x) the elimination half-life, whichever is longer, prior to Day 1 (i.e., enrollment)
Exclusion Criteria Related to Trial Procedures
- Presence of pacemakers; aneurysm clips; artificial heart valves; ear implants; foreign metal objects in the eyes, skin, or body, or any other circumstance (e.g. claustrophobia) that would contraindicate a magnetic resonance imaging (MRI) scan
- For participants of Part 1 and Part 2A, any contraindications to arterial cannulation
Exclusion Criterion for Participants with Probable Alzheimer's Disease
- Has received treatment that targeted amyloid-beta or tau within the last 24 months
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Part 1: Tracer Selection
Participants will receive a single dose of one tracer on one occasion and a single dose of a different tracer after 7 to 14 days and will be followed for 7 to 14 days for safety.
At the end of Part 1, one tracer with the best performance will be selected for further study in Part 2.
|
Radiolabeled low molecular weight compound, administered as single intravenous injection.
The mass dose of [11C]RO6924963 injected will be
Radiolabeled low molecular weight compound, administered as single intravenous injection.
The mass dose of [11C]RO6931643 injected will be
Radiolabeled low molecular weight compound, administered as single intravenous injection.
The mass dose of [18F]RO6958948 injected will be
|
Experimental: Part 2A: Test-Retest
Participants will receive a single dose of selected tracer from Part 1 on one occasion and then same tracer will be administered after 6 weeks.
Participants will be followed for 7 to 14 days after last PET tracer administration for safety.
|
Radiolabeled low molecular weight compound, administered as single intravenous injection.
The mass dose of [11C]RO6924963 injected will be
Radiolabeled low molecular weight compound, administered as single intravenous injection.
The mass dose of [11C]RO6931643 injected will be
Radiolabeled low molecular weight compound, administered as single intravenous injection.
The mass dose of [18F]RO6958948 injected will be
|
Experimental: Part 2B: Dosimetry
Participants will receive a single dose of selected tracer from Part 1 and will be followed for 7 to 14 days for evaluation of radiation dosimetry.
|
Radiolabeled low molecular weight compound, administered as single intravenous injection.
The mass dose of [11C]RO6924963 injected will be
Radiolabeled low molecular weight compound, administered as single intravenous injection.
The mass dose of [11C]RO6931643 injected will be
Radiolabeled low molecular weight compound, administered as single intravenous injection.
The mass dose of [18F]RO6958948 injected will be
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part 1: Standard Uptake Value (SUV), as Assessed by Tau PET Brain Scan
Time Frame: Day 1 up to Day 14
|
Day 1 up to Day 14
|
Part 1: Standard Uptake Value Ratio (SUVR), as Assessed by Tau PET Brain Scan
Time Frame: Day 1 up to Day 14
|
Day 1 up to Day 14
|
Part 1: SUV, as Assessed by Tau PET Scan of Whole Body
Time Frame: Day 1 up to Day 14
|
Day 1 up to Day 14
|
Part 1: SUVR, as Assessed by Tau PET Scan of Whole Body
Time Frame: Day 1 up to Day 14
|
Day 1 up to Day 14
|
Mean Residence Times for Each Organ, as Assessed by Tau PET Scan of Whole Body
Time Frame: Day 1 up to Day 14
|
Day 1 up to Day 14
|
Part 1: Distribution Volume (VT), as Assessed by Tau PET Brain Scan
Time Frame: Day 1 up to Day 14
|
Day 1 up to Day 14
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Part 2A: Absolute Percentage Difference Between Test and Retest of SUVR
Time Frame: Days 1, 28
|
Days 1, 28
|
Part 2A: Absolute Percentage Difference Between Test and Retest of VT
Time Frame: Days 1, 28
|
Days 1, 28
|
Part 2B: Effective dose (ED), as Assessed by Whole Body PET Scan
Time Frame: From the time of tracer injection on Day 1 up to 120 minutes post injection
|
From the time of tracer injection on Day 1 up to 120 minutes post injection
|
Part 2A: Absolute Percentage Difference Between Test and Retest of SUV
Time Frame: Days 1, 28
|
Days 1, 28
|
Percentage of Participants With Adverse Events (AEs)
Time Frame: Part 1: Day 1 up to Day 28, Part 2a: Day 1 up to Day 42, Part 2b: Day 1 up to Day 15
|
Part 1: Day 1 up to Day 28, Part 2a: Day 1 up to Day 42, Part 2b: Day 1 up to Day 15
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 31, 2014
Primary Completion (Actual)
February 29, 2016
Study Completion (Actual)
February 29, 2016
Study Registration Dates
First Submitted
June 17, 2014
First Submitted That Met QC Criteria
July 10, 2014
First Posted (Estimate)
July 11, 2014
Study Record Updates
Last Update Posted (Actual)
January 2, 2019
Last Update Submitted That Met QC Criteria
December 28, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BP29409
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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