Health Trials

Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer's Disease

ConditionAlzheimer's Disease
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50-90
SponsorHoffmann-La Roche

About this trial

This study aims to compare the effects of RO7568282 versus a placebo in people in the early stages of Alzheimer's disease (AD).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • RO7568282

    Drug

    RO7568282 will be administered as specified in the protocol.

  • Placebo

    Drug

    RO7568282 matching placebo will be administered as specified in the protocol.

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: RO7568282 High DoseExperimental treatment 1 intervention
Group B: RO7568282 Low DoseExperimental treatment 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)

Time frame
From baseline up to Week 72

Secondary outcomes

1

Change From Baseline Through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)

Time frame
From baseline up to Week 72
2

Change From Baseline Through Week 72 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Total Score and Instrumental Score

Time frame
From baseline up to Week 72
3

Incidence of Adverse Events (AEs)

Time frame
Up to approximately Week 76
4

Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)

Time frame
From baseline up to Week 76

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hoffmann-La Roche

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: