Alzheimer's Disease
Conditions
Brief summary
This study aims to compare the effects of RO7568282 versus a placebo in people in the early stages of Alzheimer's disease (AD).
Interventions
DRUGRO7568282
RO7568282 will be administered as specified in the protocol.
DRUGPlacebo
RO7568282 matching placebo will be administered as specified in the protocol.
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Evidence of AD pathological process, as confirmed by either amyloid positron emission tomography (PET) scan or cerebrospinal fluid (CSF) * Mild cognitive impairment (MCI) or mild dementia due to AD * Able to swallow whole capsules * Body mass index (BMI) within the range of 18-34 kilograms per square metre (kg/m²) (at screening) * Availability of an appropriate study partner
Exclusion criteria
* Any evidence of a condition other than AD that may affect cognition * Participants must not have unstable or clinically significant cardiovascular disease within the last year, chronic uncontrolled hypertension, or clinically significant electrocardiogram (ECG) abnormalities * History or presence of clinically significant cerebrovascular disease * Clinically significant cerebral abnormalities on magnetic resonance imaging (MRI) Note: Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) | From baseline up to Week 72 |
Secondary
| Measure | Time frame |
|---|---|
| Change From Baseline Through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13) | From baseline up to Week 72 |
| Change From Baseline Through Week 72 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Total Score and Instrumental Score | From baseline up to Week 72 |
| Incidence of Adverse Events (AEs) | Up to approximately Week 76 |
| Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS) | From baseline up to Week 76 |
| Plasma Concentrations of RO7568282 and its Metabolite[s] | Up to approximately Week 76 |
Contacts
CONTACTReference Study ID Number: BP46554 https://forpatients.roche.com/ No attachments to email below.
CONTACTFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
STUDY_DIRECTORClinical Trials
Hoffmann-La Roche
Outcome results
None listed