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MAyflOwer RoAD Study: A Study of RO4602522 in Patients With Moderate Severity Alzheimer Disease on Background Donepezil or Rivastigmine Therapy

This study is currently recruiting participants.
Verified April 2013 by Hoffmann-La Roche
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01677754
First received: August 30, 2012
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

This phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4602522 in patients with moderate severity Alzheimer disease. Patients who are taking background therapy of donepezil or rivastigmine for at least 6 months before baseline will be randomized to receive either one of two doses of RO4602522 or placebo for 12 months.


Condition Intervention Phase
Alzheimer Disease
 Drug: RO4602522
Drug: RO4601522
Drug: placebo
Drug: donepezil
Drug: rivastigmine
 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 PHASE II, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF RO4602522 ADDED TO THE BACKGROUND THERAPY OF THE ACETYLCHOLINESTERASE INHIBITORS DONEPEZIL OR RIVASTIGMINE IN PATIENTS WITH MODERATE SEVERITY ALZHEIMER'S DISEASE

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in Alzheimer's Disease Assessment Scale - Cognitive Behaviour Subscale (ADAS-Cog-11) score [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Alzheimer's disease Cooperative Study - Activities of Daily Living (ADCS-ADL) scale score [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]
  • Effect on behavioural symptoms: Change in Behavioural Pathology in Alzheimer's Disease Frequency-Weighted Severity Scale (BEHAVE-AD-FW)/Apathy Evaluation Scale (AES) score [ Time Frame: from baseline to Month 12 ] [ Designated as safety issue: No ]
  • Effect on global measures: Alzheimer's Disease Cooperative Study Clinician Global Impression of Change (ADCS-CGIC) scale/Global Deterioration Scale (GDS) at 12 months [ Time Frame: Month 12 ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 420
Study Start Date: November 2012
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: RO4602522 Dose A Drug: RO4602522
Dose A, 12 months
Drug: donepezil
stable dose (5-10 mg orally daily) background medication
Drug: rivastigmine
stable dose (patch 4.6 or 9.5 mg/24h) background medication
Experimental: RO4602522 Dose B Drug: RO4601522
Dose B, 12 months
Drug: donepezil
stable dose (5-10 mg orally daily) background medication
Drug: rivastigmine
stable dose (patch 4.6 or 9.5 mg/24h) background medication
Placebo Comparator: Placebo Drug: placebo
12 months
Drug: donepezil
stable dose (5-10 mg orally daily) background medication
Drug: rivastigmine
stable dose (patch 4.6 or 9.5 mg/24h) background medication

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients, 50-90 years of age inclusive at time of screening
  • Probable Alzheimer disease, based on the National Institute of Neurological and Communicative Disorders and Stroke (NINCDS)/Alzheimer's Disease and Related Disorders Association (ADRDA) and DSM-IV-TR criteria
  • MMSE score at screening between 14 and 20, inclusive
  • Body mass index (BMI) between 18 and 36 kg/m2 (inclusive) at screening
  • Modified Hachinski Ischemia Score of </= 4
  • Patients with Cornell Scale for Depression in Dementia (CSDD) scores </= 13 at screening
  • Receiving treatment with donepezil or rivastigmine for at least 6 months before baseline, with their dose and formulation stabilized at least 3 months before screening. For donepezil the dose must be 5 to 10 mg p.o. daily; for rivastigmine, though patients on tablets prior to 3 months are eligible, they must be on the patch formulation only, in a stable dose (4.6 mg/24h or 9.5 mg/24h patch) for the 3 months before screening
  • Females of childbearing potential must have a negative pregnancy test and must agree to use effective contraception
  • Generally healthy and ambulatory or ambulatory-aided (i.e., walker or cane)
  • Have a reliable caregiver or some other identified responsible person who has frequent contact with the patient

Exclusion Criteria:

  • Any neurological or psychiatric condition not specified in exceptions in protocol
  • Background of mental retardation
  • Uncontrolled behavioral symptoms incompatible with compliance or evaluability
  • Alcohol and/or substance abuse or dependence (DSM-IV-TR) in the past 2 years, except nicotine use which is allowed. However, smokers treated with nicotine replacement therapy or bupropion are excluded
  • Unstable or poorly controlled hypertension as assessed by the investigator
  • Unstable or clinically significant cardiovascular disease that could be expected to progress, recur, or change during study period to such an extent that it could bias the assessment of the clinical or mental status of the patient
  • Inadequate hepatic, renal or thyroid function
  • Positive for hepatitis B, hepatitis C or HIV infection
  • Poorly controlled diabetes
  • Requiring nursing home care
  • Current treatment for AD other than donepezil or rivastigmine
  • Participation at any time in an active AD vaccine study
  • Participation in a passive AD immunization study less than 1 year before screening
  • Psychotropic medication as defined by protocol
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01677754

Contacts
Contact: Please reference Study ID Number: BP28248 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) genentechclinicaltrials@druginfo.com

  Show 128 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: NCT01677754     History of Changes
Other Study ID Numbers: BP28248
Study First Received: August 30, 2012
Last Updated: April 29, 2013
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
Cholinesterase Inhibitors
Rivastigmine
Donepezil
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents
Central Nervous System Agents
Therapeutic Uses
Nootropic Agents

ClinicalTrials.gov processed this record on May 16, 2013