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

Sanofi

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: SAR228810

Study type: Interventional

Funder types: Industry

Identifiers

NCT01485302

U1111-1120-0550 (Other Identifier)

2011-002910-35 (EudraCT Number)

TDR12399

Details and patient eligibility

About

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

Full description

14.5 to 22 months

Enrollment: 48 patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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48 participants in 6 patient groups

Cohort 1

Experimental group

Description:

Dose 1 IV infusion

Treatment:

Drug: SAR228810

Drug: SAR228810

Cohort 2

Experimental group

Description:

Dose 2 IV infusion

Treatment:

Drug: SAR228810

Drug: SAR228810

Cohort 3

Experimental group

Description:

Dose 3 IV infusion

Treatment:

Drug: SAR228810

Drug: SAR228810

Cohort 4

Experimental group

Description:

Dose 4 IV infusion

Treatment:

Drug: SAR228810

Drug: SAR228810

Cohort 5

Experimental group

Description:

Dose 1 SC injection

Treatment:

Drug: SAR228810

Drug: SAR228810

Cohort 6

Experimental group

Description:

Dose 2 SC injection

Treatment:

Drug: SAR228810

Drug: SAR228810