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

Alzheimer's Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01485302
• Other study ID #: TDR12399
• Secondary ID: 2011-002910-35U1
• Status: Completed
• Phase: Phase 1
• First received: November 16, 2011
• Last updated: March 24, 2015
• Start date: January 2012
• Est. completion date: February 2015

Study information

• Verified date: March 2015
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial 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

Description:

14.5 to 22 months

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• SAR228810
Pharmaceutical form:solution Route of administration: intravenous
• SAR228810
Pharmaceutical form:solution Route of administration: subcutaneous

Locations

Country	Name	City	State
Bulgaria	Investigational Site Number 100001	Sofia
France	Investigational Site Number 250001	Pierre Bénite
France	Investigational Site Number 250002	Toulouse Cedex 3
Netherlands	Investigational Site Number 528001	Leiden
South Africa	Investigational Site Number 710001	Bloemfontein
Sweden	Investigational Site Number 752003	Malmö
Sweden	Investigational Site Number 752002	Mölndal
Sweden	Investigational Site Number 752001	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

Bulgaria,  France,  Netherlands,  South Africa,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients with adverse events		10 months	Yes
Secondary	AUC		1 to 112 days after dosing	No
Secondary	Cmax		1 to 112 days after dosing	No
Secondary	t1/2z		1 to 112 days after dosing	No
Secondary	brain magnetic resonance imaging		10 months	Yes
Secondary	hematology, biochemistry, coagulation		10 months	Yes
Secondary	vital signs, ECG		10 months	Yes