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Trial record 4 of 4 for:    MEM3454

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:
ClinicalTrials.gov Identifier:
NCT00884507
First Posted: April 20, 2009
Last Update Posted: November 2, 2016
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.
Information provided by (Responsible Party):
Hoffmann-La Roche
April 17, 2009
April 20, 2009
November 2, 2016
May 2009
November 2010   (Final data collection date for primary outcome measure)
Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score [ Time Frame: Week 24 ]
Change from baseline in ADAS-Cog score [ Time Frame: Week 24 ]
Complete list of historical versions of study NCT00884507 on ClinicalTrials.gov Archive Site
  • 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 ]
  • AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations. [ Time Frame: At intervals to week 24, then at week 28 ]
Same as current
Not Provided
Not Provided
 
A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease
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
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.
Not Provided
Interventional
Phase 2
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Placebo
    po daily for 24 weeks
  • Drug: RO5313534
    1mg po daily for 24 weeks
  • Drug: RO5313534
    5mg po daily for 24 weeks
  • Drug: RO5313534
    15mg po daily for 24 weeks
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
  • Experimental: RO5313534 15mg
    Intervention: Drug: RO5313534
  • Experimental: RO5313534 1mg
    Intervention: Drug: RO5313534
  • Experimental: RO5313534 5mg
    Intervention: Drug: RO5313534
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
389
November 2010
November 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Argentina,   Australia,   Canada,   France,   Germany,   Italy,   Mexico,   Poland,   Romania,   Slovakia,   Spain,   United Kingdom,   United States
 
 
NCT00884507
WN22018
2008-004012-13
Not Provided
Not Provided
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP