Single and Repeated Dosing Study to Assess the Safety and... | NCT01485302

ID	Type	Description	Link
2011-002910-35	EudraCT Number
U1111-1120-0550	Other Identifier	UTN

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Feb 2015Actual

Completion Date

Feb 2015Actual

First Submitted Date

Nov 16, 2011

First Submission Date that Met QC Criteria

Dec 1, 2011

First Posted Date

Dec 5, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 24, 2015

Last Update Posted Date

Mar 25, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
SAR228810	Drug	Pharmaceutical form:solution Route of administration: intravenous	Cohort 1 Cohort 2 Cohort 3 Cohort 4

Measure	Description	Time Frame
number of patients with adverse events		10 months

Measure	Description	Time Frame
AUC		1 to 112 days after dosing
Cmax		1 to 112 days after dosing
t1/2z

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Investigational Site Number 100001		Sofia		1612	Bulgaria
Investigational Site Number 250001

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D024801	Tauopathies
D019636	Neurodegenerative Diseases
D019965	Neurocognitive Disorders
D001523	Mental Disorders