CompletedPhase 1

Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's Patients

A Multi-center, Parallel-group, Double-blind, Placebo-controlled Single and Multiple Dose Escalation Study to Assess the Safety and Tolerability and the Pharmacokinetic Properties of SAR228810 Given as IV Infusion or as SC Injection in Patients With Mild to Moderate Alzheimer's Disease.

Lead sponsor

Sanofi

Asset

SAR228810

Listed sites

Recruiting sites

Enrollment

actual

Study population

Alzheimer’s disease

Key I/E criterion

•mild-to-moderate AD

Primary endpoint

•Adverse events

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2011-002910-35

NCT IDNCT01485302

Org study IDTDR12399

Secondary IDU1111-1120-0550UTN

Timeline

Milestones

Study first posted2011-12-05estimated

Study start2012-01 (month precision)

Primary completion2015-02actual (month precision)

Study completion2015-02actual (month precision)

Last update posted2015-03-25estimated

Assets

Drug assets

SAR228810

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Male or female patients with mild to moderate Alzheimer's disease, aged between 50 and 85 years inclusive

•Meets criteria for probable Alzheimer's of the National Institute of Neurologic and Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association

•Mini-mental state examination (MMSE)

•In reasonable and stable health state for Alzheimer's patients of this age and stage of disease as assessed by a comprehensive clinical assessment

•Magnetic resonance imaging consistent with Alzheimer's disease, not indicating any other cause for dementia symptoms than Alzheimer's disease

•Rosen Modified Hachinski Ischemic score

•If on symptomatic treatment for Alzheimer's disease (acetylcholinesterase inhibitors or/and memantine), must be stable in the last 30 days before screening

Exclusion criteria

•Clinically significant neurological disease other than Alzheimer's disease

•Had a major psychiatric disorder

•Had a history of stroke, seizures, brain neoplasms, brain surgery, or any cerebrovascular disorder (including transient ischemic attack)

•History or presence of severe, uncontrolled and/or unstable angiopathy or vasculitis.

•History or presence of clinically relevant cardiac disease.

•Currently taking anticonvulsants, anti-Parkinsonians, antipsychotics, anticoagulants or narcotic drugs, recent immunosuppressive or cancer chemotherapy drugs, or cognitive enhancers. Concomitant therapies that are allowed if given at a stable dose for at least 30 days before screening are: acetylcholinesterase inhibitors and/or memantine; antidepressants of the class of selective serotonin reuptake inhibitors (no tricyclics); acetyl salicylic acid (ASA) at a dose ≤ 160 mg/day;

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

Endpoints (7)

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

Safety / tolerability / PK

Other (unclassified)

Neuroimaging

1 endpoint

Secondary/protocol endpoint

brain magnetic resonance imaging

Time frame:10 months

descriptive

Safety / tolerability / PK

4 endpoints

Primary/protocol endpoint

number of patients with adverse events

Time frame:10 months

event count, event

Secondary/protocol endpoint

AUC

Time frame:1 to 112 days after dosing

concentration, descriptive

Secondary/protocol endpoint

Cmax

Time frame:1 to 112 days after dosing

concentration, descriptive

Secondary/protocol endpoint

vital signs, ECG

Time frame:10 months

descriptive

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

t1/2z

Time frame:1 to 112 days after dosing

descriptive

Secondary/protocol endpoint/low confidence

hematology, biochemistry, coagulation

Time frame:10 months

descriptive

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.