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

Study Overview
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Brief Summary
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Primary Objective: - To assess the safety and tolerability of escalating single and multiple doses of SAR228810 in patients with Alzheimer's disease (AD) Secondary Objective: - To evaluate the pharmacokinetic properties of SAR228810 after escalating single and multiple doses of SAR228810 in AD patients

Detailed Description
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14.5 to 22 months

Official Title
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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.

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: SAR228810
* Drug: SAR228810


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Dose 1 IV infusion | Drug: SAR228810<br>* Pharmaceutical form:solution Route of administration: intravenous<br>|
| Experimental: Cohort 2<br>Dose 2 IV infusion | Drug: SAR228810<br>* Pharmaceutical form:solution Route of administration: intravenous<br>|
| Experimental: Cohort 3<br>Dose 3 IV infusion | Drug: SAR228810<br>* Pharmaceutical form:solution Route of administration: intravenous<br>|
| Experimental: Cohort 4<br>Dose 4 IV infusion | Drug: SAR228810<br>* Pharmaceutical form:solution Route of administration: intravenous<br>|
| Experimental: Cohort 5<br>Dose 1 SC injection | Drug: SAR228810<br>* Pharmaceutical form:solution Route of administration: subcutaneous<br>|
| Experimental: Cohort 6<br>Dose 2 SC injection | Drug: SAR228810<br>* Pharmaceutical form:solution Route of administration: subcutaneous<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients with adverse events |  | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC |  | 1 to 112 days after dosing | 
| Cmax |  | 1 to 112 days after dosing | 
| t1/2z |  | 1 to 112 days after dosing | 
| brain magnetic resonance imaging |  | 10 months | 
| hematology, biochemistry, coagulation |  | 10 months | 
| vital signs, ECG |  | 10 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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mild to moderate Alzheimer's Disease