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:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT00884507
First received: April 17, 2009
Last updated: October 6, 2014
Last verified: October 2014

April 17, 2009
October 6, 2014
May 2009
November 2010   (final data collection date for primary outcome measure)
Change from baseline in ADAS-Cog score [ Time Frame: Week 24 ] [ Designated as safety issue: No ]
Same as current
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 ] [ 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 ]
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) vers us placebo added to donepezil, in patients with mild to moderate Alzheimer's dis ease. Following a screening period, patients will be randomized to one of 4 trea tments (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
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer 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
  • Experimental: 1
    Intervention: Drug: RO5313534
  • Experimental: 2
    Intervention: Drug: RO5313534
  • Experimental: 3
    Intervention: Drug: RO5313534
  • Placebo Comparator: 4
    Intervention: Drug: Placebo
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.
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Australia,   Canada,   France,   Germany,   Italy,   Mexico,   Poland,   Romania,   Slovakia,   Spain,   United Kingdom
 
NCT00884507
WN22018, 2008-004012-13
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
October 2014

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