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.

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

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: SAR228810; Drug: SAR228810

Detailed Description

14.5 to 22 months

• Study Type: Interventional
• Enrollment (Actual): 48
• Phase: Phase 1

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria, 1612
    • Investigational Site Number 100001
• France
  • Pierre Bénite, France, 69310
    • Investigational Site Number 250001
  • Toulouse Cedex 3, France, 31059
    • Investigational Site Number 250002
• Netherlands
  • Leiden, Netherlands, 2333 CL
    • Investigational Site Number 528001
• South Africa
  • Bloemfontein, South Africa, 9301
    • Investigational Site Number 710001
• Sweden
  • Malmö, Sweden, 21224
    • Investigational Site Number 752003
  • Mölndal, Sweden, 43141
    • Investigational Site Number 752002
  • Stockholm, Sweden, 14186
    • Investigational Site Number 752001

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Sanofi

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): February 1, 2015
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: November 16, 2011
• First Submitted That Met QC Criteria: December 1, 2011
• First Posted (Estimate): December 5, 2011

Study Record Updates

• Last Update Posted (Estimate): March 25, 2015
• Last Update Submitted That Met QC Criteria: March 24, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: mild to moderate Alzheimer's Disease
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: TDR12399; 2011-002910-35 (EudraCT Number); U1111-1120-0550 (Other Identifier: UTN)