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Trial record 4 of 4 for:    MEM 3454
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A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00884507
Recruitment Status : Completed
First Posted : April 20, 2009
Last Update Posted : November 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Description
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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 Design
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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


Arms and Interventions
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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


Outcome Measures
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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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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 ClinicalTrials.gov identifier (NCT number): NCT00884507


Locations
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Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00884507    
Other Study ID Numbers: WN22018
2008-004012-13
First Posted: April 20, 2009    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders