Alzheimer's DiseasePhase 2TARBELA-ADNCT07781657
Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer's Disease
A Phase 2 study testing RO7568282 in people with Alzheimer's Disease, run by Hoffmann-La Roche at 7 sites in 3 countries.
Trial summary
This study aims to compare the effects of RO7568282 versus a placebo in people in the early stages of Alzheimer's disease (AD). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- RO7568282
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 15 Nov 2026to 1 Nov 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: BP46554 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
7 sites in 3 countries
United States4 sites, 4 recruiting
- Recruiting
Basil Clinical
Laurelton, New York, 11413-2016
- Recruiting
Alzheimer's Research and Treatment Center
Stuart, Florida, 34996
- Recruiting
Alzheimer?s Research and Treatment Center
Wellington, Florida, 33414
- Recruiting
Conquest Research, LLC
Winter Park, Florida, 32789
Australia2 sites, 2 recruiting
- Recruiting
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
- Recruiting
Royal Melbourne Hospital
Parkville, Victoria, 3050
France1 site, 1 recruiting
- Recruiting
Groupement Hospitalier Est - Hôpital Neurologique
Bron, 69677
About this study
Official title: A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early Symptomatic Alzheimer's Disease
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
- Being tested
- RO7568282, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7568282Drug
RO7568282 will be administered as specified in the protocol.
PlaceboDrug
RO7568282 matching placebo will be administered as specified in the protocol.
| Study group | Role | What they receive |
|---|---|---|
| RO7568282 High Dose | Experimental | Participants will receive high dose of RO7568282. Receives: Drug: RO7568282 |
| RO7568282 Low Dose | Experimental | Participants will receive low dose of RO7568282. Receives: Drug: RO7568282 |
| Placebo | Placebo comparator | Participants will receive RO7568282 matching placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Measured: 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)
Measured: 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
Measured: From baseline up to Week 72
Incidence of Adverse Events (AEs)
Measured: Up to approximately Week 76
Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)
Measured: From baseline up to Week 76
Plasma Concentrations of RO7568282 and its Metabolite[s]
Measured: Up to approximately Week 76
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2026
- Study start15 Nov 2026 (estimated)
- Primary completion1 Nov 2029 (estimated)
- Study completion1 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07781657
- Sponsor's protocol ID
- BP46554
- Other IDs
- 2026-526158-14-00
- Acronym
- TARBELA-AD
- Status last verified
- Nov 2026
- First submitted
- 20 Aug 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of RO7568282 in Participants With Early Symptomatic Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07781657
- Acronym / sponsor ID
- TARBELA-AD / BP46554
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2029 (estimated)
- Study completion
- 1 Nov 2029 (estimated)
- First posted
- 24 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to compare the effects of RO7568282 versus a placebo in people in the early stages of Alzheimer's disease (AD).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RO7568282 High Dose | Experimental | Drug: RO7568282Participants will receive high dose of RO7568282. |
| RO7568282 Low Dose | Experimental | Drug: RO7568282Participants will receive low dose of RO7568282. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive RO7568282 matching placebo. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RO7568282RO7568282 will be administered as specified in the protocol. | Drug | RO7568282 High Dose, RO7568282 Low Dose |
| PlaceboRO7568282 matching placebo will be administered as specified in the protocol. | Drug | Placebo |
Primary outcome
Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Time frame: From baseline up to Week 72
5 secondary outcomes
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
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
Incidence of Adverse Events (AEs)
Time frame: Up to approximately Week 76
Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)
Time frame: From baseline up to Week 76
Plasma Concentrations of RO7568282 and its Metabolite[s]
Time frame: Up to approximately Week 76
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: BP46554 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
Clinical Trials study director
Hoffmann-La Roche
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RO7568282 in people with Alzheimer's Disease, run by Hoffmann-La Roche at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: BP46554 https://forpatients.roche.com/ No attachments to email below. (888-662-6728, global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.