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RO5313534

Phase 2

Alzheimer's Disease | Small molecule | Neurology |Roche Holding AG|Last Updated: Nov 2, 2016

Success Probability

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Market & Valuation

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Trial Design

Double-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment389

FDA Designations

No designations recorded

Clinical trial landscape

RO5313534 · 2 trials · 2 indications

Phase 2 1Phase 1 1
NCT00884507A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's DiseaseAlzheimer's Disease
COMPLETED389 Analytics
PHASE2COMPLETED
A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
Alzheimer's DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score
Week 24
Effect of multiple-dose memantine on single-dose pharmacokinetics of RO5313534 and of RO5313534 on steady-state pharmacokinetics of memantine
Days 16-21

Secondary Endpoints

CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview
At intervals up to week 24, then at week 28
AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.
At intervals to week 24, then at week 28
Effect of multiple-dose memantine on safety and tolerability of single-dose RO5313534
up to 14 weeks
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Study Design & Arms

MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PlaceboPLACEBO_COMPARATOR -
RO5313534 15mgEXPERIMENTAL -
RO5313534 1mgEXPERIMENTAL -
RO5313534 5mgEXPERIMENTAL -
Single ArmEXPERIMENTAL -

Interventions

NameTypeDescription
PlaceboDRUGpo daily for 24 weeks
RO5313534DRUG1mg po daily for 24 weeks
memantineDRUGmultiple doses to steady state
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites67

Inclusion Criteria: * adult patients, \>/=50 years of age; * probable Alzheimer's disease; * MMSE score at screening of 13-22; * under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for \>=4 months prior to baseline; * not requiring nursing home care, but looked after by a care...

Countries:United StatesArgentinaAustraliaCanadaFranceGermanyItalyMexicoPolandRomaniaSlovakiaSpainUnited Kingdom
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Frequently asked questions about RO5313534

What is RO5313534 used for in Alzheimer's Disease?

RO5313534 is an investigational small molecule being studied as an add-on to donepezil treatment in patients with mild to moderate Alzheimer's Disease. It is developed by Roche Holding AG (RHHBY). The drug is in Phase 2 clinical development for this indication, though no efficacy results have been reported.

What does RO5313534 target?

The molecular target of RO5313534 has not been disclosed in available information. It is a small molecule being investigated for its potential role in treating Alzheimer's Disease, but its specific mechanism of action is not publicly detailed.

Who makes RO5313534?

RO5313534 is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical trials to evaluate the drug's safety and efficacy in Alzheimer's Disease and healthy volunteers.

What phase is RO5313534 in?

RO5313534 is in Phase 2 clinical development for Alzheimer's Disease. It has completed one Phase 2 trial and one Phase 1 trial. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is RO5313534 in?

RO5313534 has been studied in two completed trials. NCT00884507 was a Phase 2 study of RO5313534 as add-on to donepezil in mild to moderate Alzheimer's Disease with 389 participants. NCT01196065 was a Phase 1 study in healthy volunteers evaluating drug interactions with memantine, enrolling 16 participants.

Is RO5313534 the same as another drug?

RO5313534 is not known to have alternative names. It is identified solely by its code name RO5313534 in clinical trial registries and available information.