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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00884507
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Placebo Drug: RO5313534 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 389 participants
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : May 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Donepezil

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: Placebo
po daily for 24 weeks

Experimental: RO5313534 15mg Drug: RO5313534
15mg po daily for 24 weeks

Experimental: RO5313534 1mg Drug: RO5313534
1mg po daily for 24 weeks

Experimental: RO5313534 5mg Drug: RO5313534
5mg po daily for 24 weeks

Primary Outcome Measures :
  1. Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. 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 ]
  2. AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations. [ Time Frame: At intervals to week 24, then at week 28 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00884507

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Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT00884507     History of Changes
Other Study ID Numbers: WN22018
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents