This study aims to compare the effects of RO7568282 versus a placebo in people in the early stages of Alzheimer's disease (AD).
The purpose of this study is to assess the efficacy and safety of RO7568282, in participants with early symptomatic Alzheimer’s disease (AD) (mild cognitive impairment [MCI] to mild dementia due to AD). Alzheimer’s disease is a progressive neurodegenerative disorder with limited therapeutic options that modify the underlying pathology.
Anticipated enrolment close date: December 2028
Who can take part
Before you take part in this study, you may need to visit our clinic to commence a screening period. During these screening visits you will have various assessments and tests so that the study doctor can find out if you are eligible to enter the study.
You may be eligible to participate if you:
- are between the ages of 50 to 90 years.
- have a reliable study partner with whom you live or have regular contact (who communicates with you at least 10 hours each week), and who can come with you to study visits or can be called during study visits. Your study partner will also be asked questions about your memory and day-to-day activities.
- have evidence of AD pathological process, as confirmed by either amyloid positron emission tomography (PET) scan or cerebrospinal fluid (CSF).
- have mild cognitive impairment (MCI) or mild dementia due to AD.
- are able to swallow whole capsules.
- have a body mass index (BMI) within the range of 18-34 kilograms per square metre (kg/m²) (at screening).
You may not be eligible to participate if you:
- have evidence of a condition other than AD that may affect cognition.
- have unstable or clinically significant cardiovascular disease within the last year, chronic uncontrolled hypertension, or clinically significant electrocardiogram (ECG) abnormalities.
- have a history or presence of clinically significant cerebrovascular disease.
- have clinically significant cerebral abnormalities on magnetic resonance imaging (MRI).
What's involved
If you agree to take part in the study and the study is suitable for you, your participation will last up to 20 months (~84 weeks, including 72 weeks of treatment, up to 8 weeks at the start to determine whether the study is a good fit for you, and 4 weeks of safety follow-up).
Assessments and tests may include:
- blood tests
- magnetic resonance imaging (MRI) scans
- positron emission tomography (PET) scans
- lumbar puncture
- patient report outcome questionnaires
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