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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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01485302
First received: November 16, 2011
Last updated: March 24, 2015
Last verified: March 2015
  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


Condition Intervention Phase
Alzheimer's Disease Drug: SAR228810 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • number of patients with adverse events [ Time Frame: 10 months ]

Secondary Outcome Measures:
  • AUC [ Time Frame: 1 to 112 days after dosing ]
  • Cmax [ Time Frame: 1 to 112 days after dosing ]
  • t1/2z [ Time Frame: 1 to 112 days after dosing ]
  • brain magnetic resonance imaging [ Time Frame: 10 months ]
  • hematology, biochemistry, coagulation [ Time Frame: 10 months ]
  • vital signs, ECG [ Time Frame: 10 months ]

Enrollment: 48
Study Start Date: January 2012
Study Completion Date: February 2015
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1
Dose 1 IV infusion
Drug: SAR228810

Pharmaceutical form:solution

Route of administration: intravenous

Experimental: Cohort 2
Dose 2 IV infusion
Drug: SAR228810

Pharmaceutical form:solution

Route of administration: intravenous

Experimental: Cohort 3
Dose 3 IV infusion
Drug: SAR228810

Pharmaceutical form:solution

Route of administration: intravenous

Experimental: Cohort 4
Dose 4 IV infusion
Drug: SAR228810

Pharmaceutical form:solution

Route of administration: intravenous

Experimental: Cohort 5
Dose 1 SC injection
Drug: SAR228810

Pharmaceutical form:solution

Route of administration: subcutaneous

Experimental: Cohort 6
Dose 2 SC injection
Drug: SAR228810

Pharmaceutical form:solution

Route of administration: subcutaneous


Detailed Description:
14.5 to 22 months
  Eligibility

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485302

Locations
Bulgaria
Investigational Site Number 100001
Sofia, Bulgaria, 1612
France
Investigational Site Number 250001
Pierre Bénite, France, 69310
Investigational Site Number 250002
Toulouse Cedex 3, France, 31059
Netherlands
Investigational Site Number 528001
Leiden, Netherlands, 2333 CL
South Africa
Investigational Site Number 710001
Bloemfontein, South Africa, 9301
Sweden
Investigational Site Number 752003
Malmö, Sweden, 21224
Investigational Site Number 752002
Mölndal, Sweden, 43141
Investigational Site Number 752001
Stockholm, Sweden, 14186
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Clinical Sciences & Operations Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01485302     History of Changes
Other Study ID Numbers: TDR12399
2011-002910-35 ( EudraCT Number )
U1111-1120-0550 ( Other Identifier: UTN )
Study First Received: November 16, 2011
Last Updated: March 24, 2015

Keywords provided by Sanofi:
mild to moderate Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 21, 2017