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Home » Clinical Trials » Alzheimer's Disease

Clinical Trial Details

Overview

Research Study Summary

A Phase 1 clinical study for patients with Alzheimer's Disease

Research Study Title

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.

Purpose

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
To Learn more
Phase

1

Gender

Both Male and Female

Age

50 to 85 Years

Overall Status

Recruiting

Lead Sponsor

Sanofi

Duration

35 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 50 Years to 85 Years

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.

Site Locations (8)

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

Contact

For site information, send an email with site number to

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT01485302

Date Last Changed: November 20, 2013

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