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

Purpose

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

Condition	Intervention	Phase
Alzheimer's Disease	Drug: SAR228810	Phase 1

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

number of patients with adverse events [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

AUC [ Time Frame: 1 to 112 days after dosing ] [ Designated as safety issue: No ]
Cmax [ Time Frame: 1 to 112 days after dosing ] [ Designated as safety issue: No ]
t1/2z [ Time Frame: 1 to 112 days after dosing ] [ Designated as safety issue: No ]
brain magnetic resonance imaging [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
hematology, biochemistry, coagulation [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]
vital signs, ECG [ Time Frame: 10 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	48
Study Start Date:	January 2012
Estimated Study Completion Date:	October 2014
Estimated Primary Completion Date:	October 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Cohort 1 Dose 1 IV infusion	Drug: SAR228810 Pharmaceutical form:solution Route of administration: intravenous
Experimental: Cohort 2 Dose 2 IV infusion	Drug: SAR228810 Pharmaceutical form:solution Route of administration: intravenous
Experimental: Cohort 3 Dose 3 IV infusion	Drug: SAR228810 Pharmaceutical form:solution Route of administration: intravenous
Experimental: Cohort 4 Dose 4 IV infusion	Drug: SAR228810 Pharmaceutical form:solution Route of administration: intravenous
Experimental: Cohort 5 Dose 1 SC injection	Drug: SAR228810 Pharmaceutical form:solution Route of administration: subcutaneous
Experimental: Cohort 6 Dose 2 SC injection	Drug: SAR228810 Pharmaceutical form:solution Route of administration: subcutaneous

Detailed Description:

14.5 to 22 months

Eligibility

Ages Eligible for Study:	50 Years to 85 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01485302

Contacts

Contact: For site information, send an email with site number to

Contact-Us@sanofi.com

Locations

Bulgaria
Investigational Site Number 100001	Active, not recruiting
Sofia, Bulgaria, 1612
France
Investigational Site Number 250001	Recruiting
Pierre Bénite, France, 69310
Investigational Site Number 250002	Active, not recruiting
Toulouse Cedex 3, France, 31059
Netherlands
Investigational Site Number 528001	Recruiting
Leiden, Netherlands, 2333 CL
South Africa
Investigational Site Number 710001	Active, not recruiting
Bloemfontein, South Africa, 9301
Sweden
Investigational Site Number 752003	Active, not recruiting
Malmö, Sweden, 21224
Investigational Site Number 752002	Active, not recruiting
Mölndal, Sweden, 43141
Investigational Site Number 752001	Active, not recruiting
Stockholm, Sweden, 14186
United Kingdom
Investigational Site Number 826001	Active, not recruiting
London, United Kingdom, SE1 1YR

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi

More Information

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01485302 History of Changes
Other Study ID Numbers:	TDR12399, 2011-002910-35, U1111-1120-0550
Study First Received:	November 16, 2011
Last Updated:	May 16, 2013
Health Authority:	Sweden: Regional Ethical Review Board

Keywords provided by Sanofi:

mild to moderate Alzheimer's Disease

Additional relevant MeSH terms:

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013