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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02792179
Recruitment Status : Completed
First Posted : June 7, 2016
Last Update Posted : November 1, 2017
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: [18F]RO6958948 Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : July 19, 2016
Actual Primary Completion Date : September 28, 2016
Actual Study Completion Date : September 28, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: [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).
Drug: [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]).

Primary Outcome Measures :
  1. Regional Standardized Uptake Value (SUV), as Assessed by the tau PET Brain Scan [ Time Frame: Day 1 ]
  2. Regional Standardized Uptake Value Ratios (SUVR), as Assessed by the Tau PET Brain Scan [ Time Frame: Day 1 ]
  3. Change in SUV for Different Brain Regions [ Time Frame: Baseline to approximately 24 months ]
  4. Change in SUVR for Different Brain Regions [ Time Frame: Baseline to approximately 24 months ]

Secondary Outcome Measures :
  1. Percentage of Participants with Adverse Events [ Time Frame: Screening to 7-14 days after Tau PET scan (Up to approximately 7 weeks) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02792179

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United States, Maryland
Johns Hopkins Medical Institutions, Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21287-0807
Sponsors and Collaborators
Hoffmann-La Roche
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche Identifier: NCT02792179    
Other Study ID Numbers: BP39126
First Posted: June 7, 2016    Key Record Dates
Last Update Posted: November 1, 2017
Last Verified: October 2017
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders