Alzheimer's Disease, Healthy Volunteer
Conditions
Brief 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.
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
Hoffmann-La Roche
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Inclusion Criteria for All Participants * 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) Inclusion Criteria for Healthy Control Participants * 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part 1: Distribution Volume (VT), as Assessed by Tau PET Brain Scan | Day 1 up to Day 14 |
| Part 1: Standard Uptake Value (SUV), as Assessed by Tau PET Brain Scan | Day 1 up to Day 14 |
| Part 1: Standard Uptake Value Ratio (SUVR), as Assessed by Tau PET Brain Scan | Day 1 up to Day 14 |
| Part 1: SUV, as Assessed by Tau PET Scan of Whole Body | Day 1 up to Day 14 |
| Part 1: SUVR, as Assessed by Tau PET Scan of Whole Body | Day 1 up to Day 14 |
| Mean Residence Times for Each Organ, as Assessed by Tau PET Scan of Whole Body | Day 1 up to Day 14 |
Secondary
| Measure | Time frame |
|---|---|
| Part 2A: Absolute Percentage Difference Between Test and Retest of VT | Days 1, 28 |
| Part 2B: Effective dose (ED), as Assessed by Whole Body PET Scan | From the time of tracer injection on Day 1 up to 120 minutes post injection |
| Part 2A: Absolute Percentage Difference Between Test and Retest of SUV | Days 1, 28 |
| Percentage of Participants With Adverse Events (AEs) | Part 1: Day 1 up to Day 28, Part 2a: Day 1 up to Day 42, Part 2b: Day 1 up to Day 15 |
| Part 2A: Absolute Percentage Difference Between Test and Retest of SUVR | Days 1, 28 |
Countries
United States
Outcome results
None listed