Recent Updates
Recently added Catalysts

SAR110894

Phase 2

Dementia Alzheimer's Type | Small molecule | Neurology |Sanofi|Last Updated: Mar 14, 2016

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment291

FDA Designations

No designations recorded

Clinical trial landscape

SAR110894 · 1 trial · 1 indication

Phase 2 1
NCT01266525Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on DonepezilDementia Alzheimer's Type
COMPLETED291 Analytics
PHASE2COMPLETED
Effect of Different Doses of SAR110894 on Cognition in Patients With Mild to Moderate Alzheimer's Disease on Donepezil
Dementia Alzheimer's TypeUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline to Week 24 in the standard 11-item total score from the 13-item Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-Cog).
Week 4, 12, and 24

Secondary Endpoints

Change from baseline in the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) global score
Week 4, 12, and 24
Change from baseline in each of the two remaining items of the ADAS-Cog (namely "delayed word recall" and "concentration/distractibility")
Week 4, 12, and 24
Change from baseline in each of the five factors from the Cognitive Drug Research System (CDR-S) computerized assessment
Week 4, 12, and 24
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SAR110894 - 0.5 mgEXPERIMENTALSAR110894, 0.5 mg once daily along with Donepezil.
SAR110894 - 2 mgEXPERIMENTALSAR110894, 2 mg once daily along with Donepezil.
SAR110894 - 5 mgEXPERIMENTALSAR110894, 5 mg once daily along with Donepezil.
PlaceboPLACEBO_COMPARATORPlacebo (for SAR110894) once daily along with Donepezil.

Interventions

NameTypeDescription
SAR110894DRUGPharmaceutical form: Capsule Route of administration: Oral
placebo (for SAR110894)DRUGPharmaceutical form: Capsule Route of administration: Oral
DonepezilDRUG5 mg or 10 mg once daily continued as taken before inclusion
Unlock Study Design Details

Eligibility Criteria

Age Range55 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites82

Inclusion criteria: * Patients with diagnosis of Alzheimer's Disease (AD) (Cannot be dementia from strokes or other causes). * Patient is on stable and well-tolerated donepezil treatment at a dose of either 5 or 10 mg daily for at least 3 months prior to screening visit. Exclusion criteria: * Age...

Countries:United StatesAustraliaCanadaFranceGermanyItalyPolandPortugalSpain
Unlock Eligibility Criteria

Frequently asked questions about SAR110894

What is SAR110894 used for?

SAR110894 is an investigational small molecule being developed for the treatment of dementia of the Alzheimer's type. It is being studied in patients with mild to moderate Alzheimer's disease who are already taking donepezil. The drug is currently in Phase 2 clinical development.

Who is developing SAR110894?

SAR110894 is being developed by Sanofi, a global biopharmaceutical company traded on the stock exchange under the ticker symbol SNY. The drug is a small molecule in the neurology therapeutic area, targeting dementia of the Alzheimer's type.

What phase is SAR110894 in?

SAR110894 is in Phase 2 clinical development. It has completed one Phase 2 trial, and no active trials are currently listed. The drug remains investigational and has not been approved for commercial use.

What clinical trials has SAR110894 been in?

SAR110894 has been studied in one completed Phase 2 clinical trial with the identifier NCT01266525. This trial evaluated the effect of different doses of SAR110894 on cognition in patients with mild to moderate Alzheimer's disease who were on donepezil. The trial enrolled 291 participants across multiple countries.

Was the SAR110894 clinical trial randomized and controlled?

Yes, the completed Phase 2 trial of SAR110894 was a randomized, double-blind, placebo-controlled study. It enrolled 291 patients aged 55 years and older with mild to moderate Alzheimer's disease. The trial was conducted in the United States, Australia, Canada, France, Germany, Italy, Poland, Portugal, and Spain.