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

NCT07781657 | Not Yet Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: BP465542026-526158-14-00
• Study Type: interventional
• Target: 450
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

  From baseline up to Week 72

Secondary Outcomes (5)

• 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

Study Arms (3)

RO7568282 High Dose

EXPERIMENTAL

Participants will receive high dose of RO7568282.

Drug: RO7568282

RO7568282 Low Dose

EXPERIMENTAL

Participants will receive low dose of RO7568282.

Drug: RO7568282

Placebo

PLACEBO COMPARATOR

Participants will receive RO7568282 matching placebo.

Drug: Placebo

Interventions

RO7568282 DRUG

RO7568282 will be administered as specified in the protocol.

RO7568282 High Dose; RO7568282 Low Dose

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Related Links

• Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: BP46554 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728; global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: August 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share