TREMHANCE

Not yet recruitingPhase 2

A Study to Investigate the Safety and Effectiveness of SAR448851 in Participants With Early Alzheimer's Disease

A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of 48-week SAR448851 Treatment Followed by Open-label Extension in Participants With Early Alzheimer's Disease

Lead sponsor

Sanofi

Asset

SAR448851

Listed sites

Recruiting sites

Enrollment

160

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•mild AD dementia•Amyloid biomarker required (PET)•CDR global 0.5-1•Study partner/caregiver required•Brain MRI excludes >4 microhemorrhages, superficial siderosis

Primary endpoints

•Phosphorylated tau 217 (p-tau217)•Part B

Identifiers

Registered as

Registry2025-524581-14CTIS

Org study IDACT23645

NCT IDNCT07688213

RegistryU1111-1328-4936ICTRP

Timeline

Milestones

Study start2026-07-01estimated

Study first posted2026-07-07actual

Last update posted2026-07-07actual

Primary completion2029-07-31estimated

Study completion2029-07-31estimated

Assets

Drug assets

SAR448851

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Participant must be 55 to 85 years (inclusive) of age, at the time of signing the informed consent.

•Diagnosis of mild cognitive impairment (MCI) due to Alzheimer's disease (AD) (National Institute on Aging-Alzheimer's Association [NIA-AA] Stage 3) or mild AD dementia (NIA-AA Stage 4).

•Have a global Clinical Dementia Rating (CDR) score 0.5 to 1.0 and a CDR-Memory Box score ≥ 0.5 at screening.

•Have a study partner who must provide separate written informed consent at screening. Study partner should be >18 years of age, have known participant for at least 1 year, and have a minimum of 8 hours per week contact with participant.

•The participant has evidence of cerebral amyloid pathology confirmed by positive visual read on amyloid positron emission tomography (PET) at screening

Exclusion criteria

•The participant has any history of significant neurological disease including but not limited to, frontotemporal dementia, Lewy body dementia, Huntington's disease, serious infection of the brain, Parkinson's disease, multiple concussions, multiple sclerosis, or epilepsy or recurrent seizures (except febrile childhood seizures).

•The participant has evidence of more than 4 microhemorrhages (<10 mm in diameter) or superficial siderosis.

•The participant carries two copies of the apolipoprotein-E epsilon 4 (APOE4) allele (APOE4/4).

•The participant is currently receiving or has previously received any anti-amyloid immunotherapy (including, but not limited to, aducanumab, lecanemab, or donanemab) or triggering receptor expressed on myeloid cells 2 (TREM-2) targeting therapy.

•The participant is currently receiving anticoagulant therapies.

•The participant has had malignancy in the 3 years prior to Screening, excluding basal cell carcinoma, squamous cell carcinoma of the skin, melanoma in situ, Stage 1 or 2 prostate cancer, fully resected renal cell cancers, or cervical carcinoma in situ that has been successfully treated.

The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Amyloid biomarkers

Neurodegeneration biomarkers

Fluid / digital biomarkers

Safety / tolerability / PK

Other (unclassified)

Amyloid biomarkers

3 endpoints

Primary/protocol endpoint

Part B: Number of participants with treatment-emergent adverse events (TEAE), including ARIA-E and ARIA-H by brain MRI, laboratory assessments, vital sign measurements, ECGs and the C-SSRS

Time frame:From Week 48 to Week 96

event count, event

Secondary/protocol endpoint

Part A and optional dose 2 cohort: Change from baseline to Week 48 in brain amyloid plaque deposition as measured by amyloid positron emission tomography (PET)

Time frame:From baseline to Week 48

change from baseline, improvement

Secondary/protocol endpoint

Part A and optional dose 2 cohort: Number of participants with ARIA-E and ARIA-H assessed by brain MRIs

Time frame:From baseline to Week 48

event count, event

Neurodegeneration biomarkers

3 endpoints

Secondary/protocol endpoint

Part A and optional dose 2 cohort: Change from baseline to Week 48 in plasma glial fibrillary acidic protein (GFAP) and cerebrospinal fluid (CSF) neurogranin (Ng)

Time frame:From baseline to Week 48

change from baseline, improvement

Secondary/protocol endpoint

Part B: Change from baseline to Week 96 in AD biomarkers: plasma p-tau217, plasma GFAP, CSF Ng

Time frame:From baseline to Week 96

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Secondary/protocol endpoint

Part B: Change from Week 48 to Week 96 in AD biomarkers: plasma p-tau217, plasma GFAP, CSF Ng

Time frame:From Week 48 to Week 96

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Fluid / digital biomarkers

2 endpoints

Secondary/protocol endpoint

Part A and optional dose 2 cohort: Change from baseline to Week 48 in CSF soluble triggering receptor expressed on myeloid cells 2 (sTREM2)

Time frame:From baseline to Week 48

change from baseline, improvement

Secondary/protocol endpoint

Part A and optional dose 2 cohort: Plasma and CSF concentrations of SAR448851

Time frame:From baseline to Week 48

concentration, descriptive

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Part A and optional dose 2 cohort: Number of participants with TEAEs and serious adverse events (SAEs), and discontinuations due to TEAEs and SAEs (including laboratory assessments, vital sign measurements, ECGs and the C-SSRS)

Time frame:From baseline to Week 48

event count, event

Other (unclassified)

1 endpoint

Primary/protocol endpoint/low confidence

Part A and optional dose 2 cohort: change from baseline to Week 48 in plasma p-tau217

Time frame:From baseline to Week 48

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.