A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: RO5313534; Drug: Placebo

• Registration Number: NCT00884507
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-04-17
• Study First Submitted QC: 2009-04-17
• Study First Posted: 2009-04-20
• Study Start: 2009-05
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Disposition First Submitted: 2016-07-08
• Disposition First Submitted QC: 2016-07-08
• Disposition First Posted: 2016-07-12
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

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 caregiver/carer.

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Exclusion Criteria

• dementia due to condition other than Alzheimer's disease;
• other significant neurological disorder;
• untreated/non-stabilized major depressive disorder;
• bipolar disorder, schizophrenia, or any other serious psychiatric condition.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RO5313534 1mg	RO5313534	-
RO5313534 15mg	RO5313534	-
Placebo	Placebo	-
RO5313534 5mg	RO5313534	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score	Week 24

Secondary Outcome Measures

Name	Time	Method
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