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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT07781657




Registration number
Help: Registration number
NCT07781657
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
20/08/2026
Date registered
Help: Date registered
24/08/2026
Date last updated
Help: Date last updated
6/11/2026

Titles & IDs
Public title
Study to Test Effects and Safety of RO7568282 in Early Symptomatic Alzheimer's Disease
Scientific 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
Additional trial identifiers [1] 0 0
2026-526158-14-00
Additional trial identifiers [2] 0 0
BP46554
Universal Trial Number (UTN)
Trial acronym
TARBELA-AD
Related trial records

Health condition
Health condition(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - RO7568282
Treatment: Drugs - Placebo

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.


Treatment: Drugs: RO7568282
RO7568282 will be administered as specified in the protocol.

Treatment: Drugs: Placebo
RO7568282 matching placebo will be administered as specified in the protocol.
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Change From Baseline to Week 72 in Clinical Dementia Rating, Sum of Boxes (CDR-SB)
Timepoint [1] 0 0
From baseline up to Week 72
Secondary outcome [1] 0 0
Change From Baseline Through Week 72 in Alzheimer's Disease Assessment Scale-Cognition 13 (ADAS-Cog-13)
Timepoint [1] 0 0
From baseline up to Week 72
Secondary outcome [2] 0 0
Change From Baseline Through Week 72 in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) Total Score and Instrumental Score
Timepoint [2] 0 0
From baseline up to Week 72
Secondary outcome [3] 0 0
Incidence of Adverse Events (AEs)
Timepoint [3] 0 0
Up to approximately Week 76
Secondary outcome [4] 0 0
Change From Baseline in Columbia-suicide Severity Rating Scale (C-SSRS)
Timepoint [4] 0 0
From baseline up to Week 76
Secondary outcome [5] 0 0
Plasma Concentrations of RO7568282 and its Metabolite[s]
Timepoint [5] 0 0
Up to approximately Week 76

Eligibility
Key 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
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Healthy volunteers
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
15/11/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/11/2029
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 0 0
Royal Melbourne Hospital - Parkville
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
3050 - Parkville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
New York
Country [3] 0 0
France
State/province [3] 0 0
Bron

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: BP46554 https://forpatients.roche.com/ No attachments to email below.
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT07781657