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Evaluation of [18F]RO6958948 as Tracer for Positron Emission Tomography (PET) Imaging of Tau Burden in Alzheimer's Disease Participants

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]RO6958948
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer's Disease

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • AD participants previously scanned with [18F]RO6958948 in Roche Study BP29409
  • 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:

Exclusion Criteria for All Participants

  • 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 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
  • Have received an investigational medication within the last 3 months or 5 times the elimination half-life, whichever is longer, prior to enrollment Exclusion Criteria Related to Trial Procedures
  • 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

Sites / Locations

  • Johns Hopkins Medical Institutions, Johns Hopkins Outpatient Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

[18F]RO6958948

Arm Description

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).

Outcomes

Primary Outcome Measures

Regional Standardized Uptake Value (SUV), as Assessed by the tau PET Brain Scan
Regional Standardized Uptake Value Ratios (SUVR), as Assessed by the Tau PET Brain Scan
Change in SUV for Different Brain Regions
Change in SUVR for Different Brain Regions

Secondary Outcome Measures

Percentage of Participants with Adverse Events

Full Information

First Posted
June 2, 2016
Last Updated
October 30, 2017
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02792179
Brief Title
Evaluation of [18F]RO6958948 as Tracer for Positron Emission Tomography (PET) Imaging of Tau Burden in Alzheimer's Disease Participants
Official Title
A Pilot Longitudinal Follow-Up Study of Tau Burden in The Brain of Subjects With Alzheimer's Disease Who Previously Participated in Study BP29409 Using [18F]RO6958948 Positron Emission Tomography
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 19, 2016 (Actual)
Primary Completion Date
September 28, 2016 (Actual)
Study Completion Date
September 28, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

5. Study Description

Brief Summary
This is a longitudinal, follow-up study in participants with Alzheimer's disease (AD) who previously participated in study BP29409 (NCT02187627). This study is designed to assess the longitudinal change of Tau pathology in the brain of participants with AD using the PET ligand [18F]RO6958948 and to assess the safety and tolerability of PET ligand.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
[18F]RO6958948
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
[18F]RO6958948
Intervention Description
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]).
Primary Outcome Measure Information:
Title
Regional Standardized Uptake Value (SUV), as Assessed by the tau PET Brain Scan
Time Frame
Day 1
Title
Regional Standardized Uptake Value Ratios (SUVR), as Assessed by the Tau PET Brain Scan
Time Frame
Day 1
Title
Change in SUV for Different Brain Regions
Time Frame
Baseline to approximately 24 months
Title
Change in SUVR for Different Brain Regions
Time Frame
Baseline to approximately 24 months
Secondary Outcome Measure Information:
Title
Percentage of Participants with Adverse Events
Time Frame
Screening to 7-14 days after Tau PET scan (Up to approximately 7 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: AD participants previously scanned with [18F]RO6958948 in Roche Study BP29409 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: Exclusion Criteria for All Participants 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 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 Have received an investigational medication within the last 3 months or 5 times the elimination half-life, whichever is longer, prior to enrollment Exclusion Criteria Related to Trial Procedures 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
Johns Hopkins Medical Institutions, Johns Hopkins Outpatient Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-0807
Country
United States

12. IPD Sharing Statement

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Evaluation of [18F]RO6958948 as Tracer for Positron Emission Tomography (PET) Imaging of Tau Burden in Alzheimer's Disease Participants

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