NCT01485302

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2012

Typical duration for phase_1

Geographic Reach
5 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 16, 2011

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 5, 2011

Completed
27 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

March 25, 2015

Status Verified

March 1, 2015

Enrollment Period

3.1 years

First QC Date

November 16, 2011

Last Update Submit

March 24, 2015

Conditions

Alzheimer's Disease

Keywords

mild to moderate Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

  • number of patients with adverse events

    10 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (6)

Cohort 1

EXPERIMENTAL

Dose 1 IV infusion

Drug: SAR228810

Cohort 2

EXPERIMENTAL

Dose 2 IV infusion

Drug: SAR228810

Cohort 3

EXPERIMENTAL

Dose 3 IV infusion

Drug: SAR228810

Cohort 4

EXPERIMENTAL

Dose 4 IV infusion

Drug: SAR228810

Cohort 5

EXPERIMENTAL

Dose 1 SC injection

Drug: SAR228810

Cohort 6

EXPERIMENTAL

Dose 2 SC injection

Drug: SAR228810

Interventions

SAR228810DRUG

Pharmaceutical form:solution Route of administration: intravenous

Cohort 1Cohort 2Cohort 3Cohort 4

Eligibility Criteria

Age50 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Investigational Site Number 100001

Sofia, 1612, Bulgaria

Location

Investigational Site Number 250001

Pierre-Bénite, 69310, France

Location

Investigational Site Number 250002

Toulouse, 31059, France

Location

Investigational Site Number 528001

Leiden, 2333 CL, Netherlands

Location

Investigational Site Number 710001

Bloemfontein, 9301, South Africa

Location

Investigational Site Number 752003

Malmo, 21224, Sweden

Location

Investigational Site Number 752002

Mölndal, 43141, Sweden

Location

Investigational Site Number 752001

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Clinical Sciences & Operations

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2011

First Posted

December 5, 2011

Study Start

January 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

March 25, 2015

Record last verified: 2015-03

Locations

NL(1)ZA(1)BU(1)SE(3)FR(2)