Clinical trial NCT01485302: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Keywords: mild to moderate Alzheimer's Disease
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-12-05
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: number of patients with adverse events
timeFrame: 10 months
Secondary outcomes:
measure: AUC
timeFrame: 1 to 112 days after dosing
measure: Cmax
timeFrame: 1 to 112 days after dosing
measure: t1/2z
timeFrame: 1 to 112 days after dosing
measure: brain magnetic resonance imaging
timeFrame: 10 months
measure: hematology, biochemistry, coagulation
timeFrame: 10 months
measure: vital signs, ECG
timeFrame: 10 months
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100001
city: Pierre Bénite
country: France
facility: Investigational Site Number 250001
city: Toulouse Cedex 3
country: France
facility: Investigational Site Number 250002
city: Leiden
country: Netherlands
facility: Investigational Site Number 528001
city: Bloemfontein
country: South Africa
facility: Investigational Site Number 710001
city: Malmö
country: Sweden
facility: Investigational Site Number 752003
city: Mölndal
country: Sweden
facility: Investigational Site Number 752002
city: Stockholm
country: Sweden
facility: Investigational Site Number 752001
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: