TRONTINEMAB for Alzheimer's disease

Inclusion criteria

• {"criterion_text":"- 1. Age 50 to 85 years (inclusive) at screening"}
• {"criterion_text":"- 2. Probable mild to moderate AD dementia (consistent with NIA-AA core clinical criteria for probable AD dementia) (McKhann et al 2011) or prodromal AD (consistent with the NIA-AA diagnostic criteria and guidelines for mild cognitive impairment due to AD) (Albert et al 2011)"}
• {"criterion_text":"- 3. Mini-Mental State Examination (MMSE) score of 18 to 28 points, inclusive, within 84 days before baseline"}
• {"criterion_text":"- 4. Clinical Dementia Rating-Global Score (CDR-GS) of 0.5, 1, or 2 within 84 days before baseline"}
• {"criterion_text":"- 5. Positive amyloid PET scan (cut-off: > 50 Centiloid units) within 12 months before baseline"}
• {"criterion_text":"- 6. In case of treatment with symptomatic AD medications, dosing regimen must be stable for at least 8 weeks prior to baseline and until randomization"}

Exclusion criteria

• {"criterion_text":"- 1. Any condition other than AD that may affect cognition"}
• {"criterion_text":"- 2. Significant cerebral abnormalities"}
• {"criterion_text":"- 3. History or presence of intracranial mass (e.g., glioma, meningioma) that could potentially impair cognition"}
• {"criterion_text":"- 4. History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder, Cancer, unless cured or currently not needing treatment. Note: History of major depression is acceptable, if participant has had no episode within the past year, or is considered in remission, or depression is controlled by treatment"}
• {"criterion_text":"- 5. History of any clinically significant hematological diseases, clinically significant ophthalmologic disease or chronic kidney disease"}
• {"criterion_text":"- 6. Atrial fibrillation, cardiovascular disease or uncontrolled hypertension"}

Primary endpoints

• {"endpoint_text":"- 1. Nature, frequency, severity, and timing of AEs, including – for Part 1 only – DLAEs. Significant assessments reported as AEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead ECG, and brain MRI findings (including the occurrence of vasogenic edema and hemorrhage) (Part 1-4)","definition_or_measurement_approach":"Assessed by adverse event reporting and clinical assessments including clinical laboratory assessments, vital signs, physical and neurological examinations, 12-lead ECG, and brain MRI (including monitoring for vasogenic edema and hemorrhage). DLAEs evaluated specifically in Part 1."}
• {"endpoint_text":"- 2. Change from baseline in brain amyloid load, as measured by amyloid PET scan (Part 3)","definition_or_measurement_approach":"Measured by amyloid PET scan; change from baseline in brain amyloid load (Part 3)."}

Secondary endpoints

• {"endpoint_text":"- 1. Change from baseline in brain amyloid load, as measured by amyloid PET scan (Part 1, 2 and 4 only)","definition_or_measurement_approach":"Measured by amyloid PET scan; change from baseline in brain amyloid load in Parts 1, 2 and 4."}
• {"endpoint_text":"- 2. Plasma Concentration of RO7126209 at specified timepoints","definition_or_measurement_approach":"Pharmacokinetic sampling of plasma RO7126209 at predefined timepoints."}
• {"endpoint_text":"- 3. CSF concentration of RO7126209","definition_or_measurement_approach":"CSF sampling to measure RO7126209 concentration."}
• {"endpoint_text":"- 4. Incidence and titer of anti-RO7126209 ADAs over time","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADAs) over time using immunogenicity assays (incidence and titer)."}

Spain

Earliest CTIS Part Ii Submission Date

14-02-2024

Latest Decision Or Authorization Date

11-09-2025

Processing Time Days

575

Number Of Sites

7

Number Of Participants

55

Poland

Earliest CTIS Part Ii Submission Date

14-02-2024

Latest Decision Or Authorization Date

12-09-2025

Processing Time Days

576

Number Of Sites

4

Number Of Participants

44

Primary sponsor

Full Name

F. Hoffmann-La Roche AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Bioclinica Inc.

Responsibilities

Other Third Party Duty

Name

Fortrea Inc.

Responsibilities

Other Third Party Duty

Name

Perceptive Informatics Inc.

Responsibilities

Other Third Party Duty

Name

Signant Health Global LLC

Responsibilities

Other Third Party Duty

Name

Greenphire LLC

Responsibilities

Patient Concierge, Patient Reimbursement

Name

Q Squared Solutions Limited

Responsibilities

Other Third Party Duty

Name

Avid Radiopharmaceuticals Inc.

Responsibilities

Other Third Party Duty

Name

Axon Communications Inc.

Responsibilities

Other Third Party Duty

Third parties

• {"country":"United States","full_name":"Greenphire LLC","duties_or_roles":"Patient Concierge, Patient Reimbursement","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Q Squared Solutions Limited","duties_or_roles":"Other Third Party Duty","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Avid Radiopharmaceuticals Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Axon Communications Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Bioclinica Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Fortrea Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Signant Health Global LLC","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}