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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02792179

Enrollment

Registered

2016-06-07

Start date

2016-07-19

Completion date

2016-09-28

Last updated

2017-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

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.

Interventions

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 \[mCi\]).

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

25 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Regional Standardized Uptake Value (SUV), as Assessed by the tau PET Brain Scan	Day 1
Regional Standardized Uptake Value Ratios (SUVR), as Assessed by the Tau PET Brain Scan	Day 1
Change in SUV for Different Brain Regions	Baseline to approximately 24 months
Change in SUVR for Different Brain Regions	Baseline to approximately 24 months

Secondary

Measure	Time frame
Percentage of Participants with Adverse Events	Screening to 7-14 days after Tau PET scan (Up to approximately 7 weeks)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026