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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SAR228810
SAR228810
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring mild to moderate Alzheimer's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Investigational Site Number 100001
  • Investigational Site Number 250001
  • Investigational Site Number 250002
  • Investigational Site Number 528001
  • Investigational Site Number 710001
  • Investigational Site Number 752003
  • Investigational Site Number 752002
  • Investigational Site Number 752001

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Cohort 5

Cohort 6

Arm Description

Dose 1 IV infusion

Dose 2 IV infusion

Dose 3 IV infusion

Dose 4 IV infusion

Dose 1 SC injection

Dose 2 SC injection

Outcomes

Primary Outcome Measures

number of patients with adverse events

Secondary Outcome Measures

AUC
Cmax
t1/2z
brain magnetic resonance imaging
hematology, biochemistry, coagulation
vital signs, ECG

Full Information

First Posted
November 16, 2011
Last Updated
March 24, 2015
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01485302
Brief Title
Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's Patients
Official 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.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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
14.5 to 22 months

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
mild to moderate Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Dose 1 IV infusion
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Dose 2 IV infusion
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Dose 3 IV infusion
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Dose 4 IV infusion
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Dose 1 SC injection
Arm Title
Cohort 6
Arm Type
Experimental
Arm Description
Dose 2 SC injection
Intervention Type
Drug
Intervention Name(s)
SAR228810
Intervention Description
Pharmaceutical form:solution Route of administration: intravenous
Intervention Type
Drug
Intervention Name(s)
SAR228810
Intervention Description
Pharmaceutical form:solution Route of administration: subcutaneous
Primary Outcome Measure Information:
Title
number of patients with adverse events
Time Frame
10 months
Secondary Outcome Measure Information:
Title
AUC
Time Frame
1 to 112 days after dosing
Title
Cmax
Time Frame
1 to 112 days after dosing
Title
t1/2z
Time Frame
1 to 112 days after dosing
Title
brain magnetic resonance imaging
Time Frame
10 months
Title
hematology, biochemistry, coagulation
Time Frame
10 months
Title
vital signs, ECG
Time Frame
10 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Sciences & Operations
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site Number 100001
City
Sofia
ZIP/Postal Code
1612
Country
Bulgaria
Facility Name
Investigational Site Number 250001
City
Pierre Bénite
ZIP/Postal Code
69310
Country
France
Facility Name
Investigational Site Number 250002
City
Toulouse Cedex 3
ZIP/Postal Code
31059
Country
France
Facility Name
Investigational Site Number 528001
City
Leiden
ZIP/Postal Code
2333 CL
Country
Netherlands
Facility Name
Investigational Site Number 710001
City
Bloemfontein
ZIP/Postal Code
9301
Country
South Africa
Facility Name
Investigational Site Number 752003
City
Malmö
ZIP/Postal Code
21224
Country
Sweden
Facility Name
Investigational Site Number 752002
City
Mölndal
ZIP/Postal Code
43141
Country
Sweden
Facility Name
Investigational Site Number 752001
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden

12. IPD Sharing Statement

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

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