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: August 4, 2014
Last verified: August 2014
  Purpose

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.


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:


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: 389
Study Start Date: May 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 67 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: 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: August 4, 2014
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 August 20, 2014