Recruiting
Phase 2

RO7568282

Sponsor:

Hoffmann-La Roche

Code:

NCT07781657

Conditions

Alzheimer's Disease

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

RO7568282

Placebo

Study Details

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

Study ID

NCT07781657

Start date

Nov 15, 2026

Status verified date

Nov, 2026

Completion date

Nov 1, 2029

Anticipated

Primary completion date

Nov 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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/exclusion criteria may apply.

Study Design

Enrollment

450 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: RO7568282 High Dose

Participants will receive high dose of RO7568282.

experimental: RO7568282 Low Dose

Participants will receive low dose of RO7568282.

placebo comparator: Placebo

Participants will receive RO7568282 matching placebo.

Interventions

RO7568282

RO7568282 will be administered as specified in the protocol.

Placebo

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

Primary outcome measure

  • Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB) [ Time Frame: From baseline up to Week 72 ]

Central Contacts and Locations

Central contacts

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

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

Locations

Alzheimer's Research and Treatment Center

Recruiting

Stuart, Florida, United States, 34996

Alzheimer?s Research and Treatment Center

Recruiting

Wellington, Florida, United States, 33414

Conquest Research, LLC

Recruiting

Winter Park, Florida, United States, 32789

Basil Clinical

Recruiting

Laurelton, New York, United States, 11413-2016

More Information

Sponsor

Hoffmann-La Roche

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by Hoffmann-La Roche on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.