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

• Register: ClinicalTrials.gov
• Last refreshed on: 7 April 2015
• Main ID: NCT01485302
• Date of registration: 16/11/2011
• Prospective Registration: Yes
• Primary sponsor: Sanofi
• Public title: Single and Repeated Dosing Study to Assess the Safety and the Concentration-time Profile of SAR228810 in Alzheimer's Patients
• Scientific 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.
• Date of first enrolment: January 2012
• Target sample size: 48
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01485302
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Bulgaria, France, Netherlands, South Africa, Sweden, United Kingdom

Contacts

• Name: Clinical Sciences & Operations
• Affiliation: Sanofi

Key inclusion & exclusion 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.



Age minimum: 50 Years
Age maximum: 85 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer's Disease

Intervention(s)

Drug: SAR228810

Primary Outcome(s)

number of patients with adverse events [Time Frame: 10 months]

Secondary Outcome(s)

t1/2z [Time Frame: 1 to 112 days after dosing]

hematology, biochemistry, coagulation [Time Frame: 10 months]

AUC [Time Frame: 1 to 112 days after dosing]

Cmax [Time Frame: 1 to 112 days after dosing]

vital signs, ECG [Time Frame: 10 months]

brain magnetic resonance imaging [Time Frame: 10 months]

Secondary ID(s)

TDR12399

2011-002910-35

U1111-1120-0550

Source(s) of Monetary Support

Please refer to primary and secondary sponsors