Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
Age
18–80
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
All participants
Total body weight between 45 and 120 kilogram (kg), inclusive
Agreement not to donate blood or blood products for transfusion for the duration of the study and for 1 year after final dose of study drug
In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead electrocardiogram (ECG), laboratory tests, and vital signs
Clinical laboratory evaluations (including chemistry panel fasted \[fasted at least 8 hours\], complete blood count (CBC), and urine analysis) within the reference range for the test laboratory, unless deemed not clinically significant by the investigator
Negative test for selected drugs of abuse at screening and at check-in
Agreement to use highly effective contraception measures
Healthy Participants
Ages 18-80 years inclusive
No history of symptomatic cognitive decline and no concern about clinically significant cognitive impairment by the participant or by the investigator
Participants who enroll into a cohort that requires lumbar puncture
No contraindication to lumbar dural puncture, including coagulopathy, concomitant anticoagulation, thrombocytopenia, prior lumbar spinal surgery, or other factor that precludes safe lumbar puncture in the opinion of the investigator
Participants with Alzheimer's disease
Ages 50-80 years, inclusive
The participant should be capable of completing assessments either alone or with the help of the caregiver
Availability of a person (caregiver) who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to provide information at clinic visits, which require partner input for scale completion, and signs the necessary consent form
Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing
Clinical diagnosis of probable Alzheimer's disease dementia based on National Institute on Aging-Alzheimer's Association criteria
Screening mini-mental state examination (MMSE) score of 16-28 points, inclusive
Screening Clinical Dementia Rating-Global Score (CDR-GS) of 0.5, 1.0, or 2.0
If already taking cholinesterase inhibitor and/or memantine therapy for Alzheimer's disease, on a stable dose for at least 4 weeks prior to screening. There should be no intent to, discontinue, or alter the dose of any Alzheimer's disease therapy for the duration of the study
You may not be if
Any participants
Pregnant or lactating, or intending to become pregnant within 16 weeks after last dose of study drug
Participation in a clinical trial within 30 days before randomization; use of any experimental oral therapy within 30 days or 5 half-lives prior to Day 1, whichever is greater; or use of any biologic therapy within 12 weeks or 5 half-lives prior to Day 1, whichever is greater
Any non-experimental vaccine within 2 weeks of randomization, until 2 weeks after the last dose
Surgery or hospitalization during the 4 weeks prior to screening
Planned procedure or surgery during the study
Blood transfusion within 8 weeks prior to screening
Donation or loss of blood (excluding the volume of blood that will be drawn during screening procedures) as follows: 50-499 milliliters (mL) of blood within 30 days or greater than (\>) 499 mL of blood within 56 days prior to study drug administration
Poor peripheral venous access
Positive for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody
Illicit drug or alcohol abuse within 12 months prior to screening, in the investigator's judgment
Administration of any herbal or nutritional supplements (with the exception of standard vitamins and calcium supplements) within 7 days prior to study dose
Past history of seizures, prior traumatic brain injury, schizophrenia, schizoaffective disorder, or bipolar disorder
At risk of suicide in the opinion of the investigator
Serious infection requiring oral and IV antibiotics within 30 days prior to screening
Any serious medical condition or abnormality in clinical laboratory tests; systemically, clinically immunocompromised because of continuing effects of immune-suppressing medication
Participants with Alzheimer's disease
History or presence of clinically evident vascular disease potentially affecting the brain
History or presence of stroke within the previous 2 years or documented history of transient ischemic attack within the previous 12 months
History or presence of intracranial tumor that is clinically relevant in the opinion of the investigator
Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae
History or presence of central nervous system (CNS) or systemic autoimmune disorders potentially causing progressive neurologic disease with associated cognitive deficits
History or presence of a neurologic disease other than Alzheimer's disease that may affect cognition
Magnetic resonance imaging (MRI) evidence of 1) more than two lacunar infarcts, 2) any territorial infarct less than (\>) 1 centimeters (cm), or 3) significant fluid attenuated inversion recovery (FLAIR) hyperintense lesions in the cerebral white matter that may, in the investigator's opinion, contribute to cognitive dysfunction
Clareo Health | A Study of RO7105705 in Healthy Participants and Participants With Mild-to-Moderate Alzheimer's Disease
