ClinicalTrials.gg
RecruitingNCT07781657TARBELA-ADUpdated Nov 6, 2026

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

A Phase 2 interventional study of RO7568282 and Placebo in Alzheimer's Disease, sponsored by Hoffmann-La Roche. Recruiting at 7 sites in 3 countries. Open to participants aged 50 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-11-06.

Sponsored by Hoffmann-La Roche · Phase 2, Interventional, and Treatment

Updated Nov 6, 2026Now RecruitingFirst sites in United States, Australia and France+3 moreGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
450
Allocation
Randomized
Ages
50 Years to 90 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Alzheimer's Disease

Browse trials for

03

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's planned enrollment of 450 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,101 studies on the registry; 87 are open to participants now.

Of its 330 completed or terminated interventional studies of FDA-regulated products, 248 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
50 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • (BMI) within the range of 18-34 kilograms per square metre (kg/m²) (at screening)
  • Availability of an appropriate study partner

Exclusion criteria

Exclusion Criteria:

  • Any evidence of a condition other than AD that may affect cognition
  • Participants must not have unstable or cardiovascular disease within the last year, chronic uncontrolled hypertension, or clinically significant (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.

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
450 participants (estimated)

Study arms

  • Experimental
    RO7568282 High Dose

    Participants will receive high dose of RO7568282.

    Drug: RO7568282

  • Experimental
    RO7568282 Low Dose

    Participants will receive low dose of RO7568282.

    Drug: RO7568282

  • Placebo comparator
    Placebo

    Participants will receive RO7568282 matching placebo.

    Drug: Placebo

Interventions

  • DrugRO7568282

    RO7568282 will be administered as specified in the protocol.

  • DrugPlacebo

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

06

What researchers measure

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

  5. Plasma Concentrations of RO7568282 and its Metabolite[s]

    Time frame: Up to approximately Week 76

07

Study locations

7 of 7 sites recruiting
08

References and documents

Individual participant data

Plan to share: Yes — For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

09

Updates

2 registry updates since Sep 25, 2026
Status
Not yet recruiting→Recruiting
changed Nov 6, 2026
Sites
7 sites added — first sites in United States, Australia and France. Basil Clinical is now Recruiting
Show 7 added (4 United States, 2 Australia, 1 France)
  • Basil Clinical · Laurelton, United States
  • Alzheimer's Research and Treatment Center · Stuart, United States
  • Alzheimer?s Research and Treatment Center · Wellington, United States
  • Conquest Research, LLC · Winter Park, United States
  • Royal Prince Alfred Hospital · Camperdown, Australia
  • Royal Melbourne Hospital · Parkville, Australia
  • Groupement Hospitalier Est - Hôpital Neurologique · Bron, France
across 2 updates, Oct 7, 2026 – Nov 6, 2026
Start date
Oct 31, 2026→Nov 15, 2026
Nov 6, 2026
Show all 2 updates
  1. Nov 6, 2026
    Not yet recruiting→Recruiting
    6 sites added — first sites in Australia and France. Basil Clinical is now Recruiting
    Show 6 added (3 United States, 2 Australia, 1 France)
    • Alzheimer's Research and Treatment Center · Stuart, United States
    • Alzheimer?s Research and Treatment Center · Wellington, United States
    • Conquest Research, LLC · Winter Park, United States
    • Royal Prince Alfred Hospital · Camperdown, Australia
    • Royal Melbourne Hospital · Parkville, Australia
    • Groupement Hospitalier Est - Hôpital Neurologique · Bron, France
    Start date Oct 31, 2026→Nov 15, 2026
    + 1 other change: verification date
  2. Oct 7, 2026
    1 site added — first site in United States
    Show site
    • Basil Clinical · Laurelton, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07781657
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Aug 24, 2026
Start date
Nov 15, 2026 (estimated)
Primary completion
Nov 1, 2029 (estimated)
Completion
Nov 1, 2029 (estimated)
Last update
Nov 6, 2026

Study contacts

Reference Study ID Number: BP46554 https://forpatients.roche.com/ No attachments to email below.
Contact
global-roche-genentech-trials@gene.com
888-662-6728
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Contact
Clinical Trials
study director · Hoffmann-La Roche

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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