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

This study has been completed.

Sponsor:

Information provided by:

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT00884507

First received: April 17, 2009

Last updated: January 17, 2012

Last verified: January 2012

History of Changes

Purpose

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.

Condition	Intervention	Phase
Alzheimer Disease	Drug: RO5313534 Drug: Placebo	Phase 2

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

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Donepezil hydrochloride Donepezil

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:

Change from baseline in ADAS-Cog score [ Time Frame: Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview [ Time Frame: At intervals up to week 24, then at week 28 ] [ Designated as safety issue: No ]
AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations. [ Time Frame: At intervals to week 24, then at week 28 ] [ Designated as safety issue: No ]

Enrollment:	332
Study Start Date:	May 2009
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: RO5313534 1mg po daily for 24 weeks
Experimental: 2	Drug: RO5313534 5mg po daily for 24 weeks
Experimental: 3	Drug: RO5313534 15mg po daily for 24 weeks
Placebo Comparator: 4	Drug: Placebo po daily for 24 weeks

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884507

Show 66 Study Locations

Sponsors and Collaborators

Hoffmann-La Roche

Investigators

Study Director:

Clinical Trials

Hoffmann-La Roche

More Information

No publications provided

Responsible Party:	Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier:	NCT00884507 History of Changes
Other Study ID Numbers:	WN22018, 2008-004012-13
Study First Received:	April 17, 2009
Last Updated:	January 17, 2012
Health Authority:	United States: Food and Drug Administration

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
Donepezil

Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013

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