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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

NCT02187627 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 52

Last updated 2019-01-02

No results posted yet for this study

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. 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.

Conditions

  • Alzheimer's Disease, Healthy Volunteer

Interventions

DRUG

[11C]RO6924963

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) \[10-20 millicurie (mCi)\].

DRUG

[11C]RO6931643

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).

DRUG

[18F]RO6958948

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.

Sponsors & Collaborators

Principal Investigators

  • Clinical Trials · Hoffmann-La Roche

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-02-29
Completion
2016-02-29

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02187627 on ClinicalTrials.gov