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

Alzheimer's Disease Clinical Trial

Official title:

A Dose-ranging, Randomized, Double-blind , Placebo-controlled Study of the Effect of RO5313534, Used as add-on Therapy to Donepezil, on Cognitive Function in Patients With Mild to Moderate Symptoms of Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00884507
• Other study ID #: WN22018
• Secondary ID: 2008-004012-13
• Status: Completed
• Phase: Phase 2
• First received: April 17, 2009
• Last updated: November 1, 2016
• Start date: May 2009
• Est. completion date: November 2010

Study information

• Verified date: November 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 389
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

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.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• Placebo
po daily for 24 weeks
• RO5313534
1mg po daily for 24 weeks
• RO5313534
5mg po daily for 24 weeks
• RO5313534
15mg po daily for 24 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Canada,  France,  Germany,  Italy,  Mexico,  Poland,  Romania,  Slovakia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score		Week 24	No
Secondary	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	No
Secondary	AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations.		At intervals to week 24, then at week 28	No