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Alzheimer's Disease, Healthy VolunteerPhase 1NCT02187627

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

A Phase 1 study testing [11C]RO6924963, [11C]RO6931643 and [18F]RO6958948 in people with Alzheimer's Disease, Healthy Volunteer, run by Hoffmann-La Roche at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 25 years and olderHealthy volunteers can take part
Conditions the study is for
Alzheimer's Disease, Healthy Volunteer
What is being tested?
[11C]RO6924963, [11C]RO6931643 and [18F]RO6958948
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
52 participants
Where
2 sitesUnited States
Study dates
31 Aug 2014to 29 Feb 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
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)
  • 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
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  • 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

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
  • 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
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  • 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)
  • 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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Parexel International; Harbor Hospital Center

    Baltimore, Maryland, 21225

  • Johns Hopkins Universtiy; Radiology Dept

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: 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.

Being tested
[11C]RO6924963, [11C]RO6931643, [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.

  • [11C]RO6924963Drug

    Radiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of [11C]RO6924963 injected will be </=10 micrograms (mcg), injection volume </=20 milliliters (mL). Target injected activity for [11C]RO6924963 will be 370-740 megabecquerel (MBq) [10-20 millicurie (mCi)].

  • [11C]RO6931643Drug

    Radiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of [11C]RO6931643 injected will be </=10 mcg, injection volume </=20 mL. Target injected activity for [11C]RO6931643 will be 370-740 MBq (10-20 mCi).

  • [18F]RO6958948Drug

    Radiolabeled low molecular weight compound, administered as single intravenous injection. The mass dose of [18F]RO6958948 injected will be </=10 mcg, injection volume </=20 mL. Target injected activity for [18F]RO6958948 will be 185-370 MBq (5-10 mCi). The final activity of [18F] RO6958948 will be adjusted up to 10 mCi per scan to allow sufficient counts by end of 200 minutes post radiotracer injection.

Study groups in NCT02187627
Study groupRoleWhat they receive
Part 1: Tracer SelectionExperimentalParticipants 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.
Receives: Drug: [11C]RO6924963; Drug: [11C]RO6931643; Drug: [18F]RO6958948
Part 2A: Test-RetestExperimentalParticipants 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.
Receives: Drug: [11C]RO6924963; Drug: [11C]RO6931643; Drug: [18F]RO6958948
Part 2B: DosimetryExperimentalParticipants 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.
Receives: Drug: [11C]RO6924963; Drug: [11C]RO6931643; Drug: [18F]RO6958948

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Part 1: Standard Uptake Value (SUV), as Assessed by Tau PET Brain Scan

    Measured: Day 1 up to Day 14

  2. Part 1: Standard Uptake Value Ratio (SUVR), as Assessed by Tau PET Brain Scan

    Measured: Day 1 up to Day 14

  3. Part 1: SUV, as Assessed by Tau PET Scan of Whole Body

    Measured: Day 1 up to Day 14

  4. Part 1: SUVR, as Assessed by Tau PET Scan of Whole Body

    Measured: Day 1 up to Day 14

  5. Mean Residence Times for Each Organ, as Assessed by Tau PET Scan of Whole Body

    Measured: Day 1 up to Day 14

  6. Part 1: Distribution Volume (VT), as Assessed by Tau PET Brain Scan

    Measured: Day 1 up to Day 14

Secondary outcomes (5)

  1. Part 2A: Absolute Percentage Difference Between Test and Retest of SUVR

    Measured: Days 1, 28

  2. Part 2A: Absolute Percentage Difference Between Test and Retest of VT

    Measured: Days 1, 28

  3. Part 2B: Effective dose (ED), as Assessed by Whole Body PET Scan

    Measured: From the time of tracer injection on Day 1 up to 120 minutes post injection

  4. Part 2A: Absolute Percentage Difference Between Test and Retest of SUV

    Measured: Days 1, 28

  5. Percentage of Participants With Adverse Events (AEs)

    Measured: Part 1: Day 1 up to Day 28, Part 2a: Day 1 up to Day 42, Part 2b: Day 1 up to Day 15

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jul 2014 (estimated)
  2. Study start31 Aug 2014
  3. Primary completion29 Feb 2016
  4. Study completion29 Feb 2016

Resources

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
Parallel groups
Masking
None (open label)
Enrolment
52 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02187627
Sponsor's protocol ID
BP29409
Status last verified
Dec 2018
First submitted
17 Jun 2014
Last updated
2 Jan 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [11C]RO6924963, [11C]RO6931643 and [18F]RO6958948 in people with Alzheimer's Disease, Healthy Volunteer, run by Hoffmann-La Roche at 2 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 12 inclusion and 15 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 2 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 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 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?

Part 1: Standard Uptake Value (SUV), as Assessed by Tau PET Brain Scan (time frame: Day 1 up to Day 14). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02187627.

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 2 Jan 2019.

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