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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01485302
First received: November 16, 2011
Last updated: June 18, 2014
Last verified: June 2014

November 16, 2011
June 18, 2014
January 2012
February 2015   (final data collection date for primary outcome measure)
number of patients with adverse events [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01485302 on ClinicalTrials.gov Archive Site
  • AUC [ Time Frame: 1 to 112 days after dosing ] [ Designated as safety issue: No ]
  • Cmax [ Time Frame: 1 to 112 days after dosing ] [ Designated as safety issue: No ]
  • t1/2z [ Time Frame: 1 to 112 days after dosing ] [ Designated as safety issue: No ]
  • brain magnetic resonance imaging [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
  • hematology, biochemistry, coagulation [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
  • vital signs, ECG [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

14.5 to 22 months

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: SAR228810

    Pharmaceutical form:solution

    Route of administration: intravenous

  • Drug: SAR228810

    Pharmaceutical form:solution

    Route of administration: subcutaneous

  • Experimental: Cohort 1
    Dose 1 IV infusion
    Intervention: Drug: SAR228810
  • Experimental: Cohort 2
    Dose 2 IV infusion
    Intervention: Drug: SAR228810
  • Experimental: Cohort 3
    Dose 3 IV infusion
    Intervention: Drug: SAR228810
  • Experimental: Cohort 4
    Dose 4 IV infusion
    Intervention: Drug: SAR228810
  • Experimental: Cohort 5
    Dose 1 SC injection
    Intervention: Drug: SAR228810
  • Experimental: Cohort 6
    Dose 2 SC injection
    Intervention: Drug: SAR228810
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
48
February 2015
February 2015   (final data collection date for primary outcome measure)

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.

Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   France,   Netherlands,   South Africa,   Sweden
 
NCT01485302
TDR12399, 2011-002910-35, U1111-1120-0550
No
Sanofi
Sanofi
Not Provided
Study Director: Clinical Sciences & Operations Sanofi
Sanofi
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP