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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01677754
First received: August 30, 2012
Last updated: February 23, 2015
Last verified: February 2015
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 acetylcholinesterase inhibitors alone or in combination with memantine for at least 4 months before screening will be randomized to receive either one of two doses of RO4602522 or placebo for 12 months.


Condition Intervention Phase
Alzheimer Disease
 Drug: RO4601522
Drug: RO4602522
Drug: donepezil
Drug: galantamine
Drug: memantine
Drug: placebo
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 BACKGROUND ALZHEIMER'S DISEASE THERAPY 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 ]
Enrollment: 544
Study Start Date: November 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Drug: donepezil
stable dose background medication
Drug: galantamine
stable dose background medication
Drug: memantine
stable dose background medication in combination with AChEIs
Drug: placebo
12 months
Drug: rivastigmine
stable dose background medication
Experimental: RO4602522 Dose A Drug: RO4602522
Dose A, 12 months
Drug: donepezil
stable dose background medication
Drug: galantamine
stable dose background medication
Drug: memantine
stable dose background medication in combination with AChEIs
Drug: rivastigmine
stable dose background medication
Experimental: RO4602522 Dose B Drug: RO4601522
Dose B, 12 months
Drug: donepezil
stable dose background medication
Drug: galantamine
stable dose background medication
Drug: memantine
stable dose background medication in combination with AChEIs
Drug: rivastigmine
stable dose 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 13 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, galantamine or any of these AChEIs in combination with memantine for at least 4 months before screening, with their dose and formulation stabilized at least 3 months before screening. All formulation and dosages are allowed except donezepil 23 mg (alone or in combination)
  • 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 that may currently or during the course of the study impair cognition or functioning that is not associated with Alzheimer's disease
  • 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. Patients living in assisted living facilities are allowed if a reliable caregiver is available (see inclusion criteria)
  • Current treatment for AD other than those listed in inclusion criteria
  • Participation at any time in an active AD vaccine study
  • Participation in a passive AD immunization study less than 1 year before screening, with exceptions as per protocol
  • Psychotropic medication as defined by protocol
  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: NCT01677754

  Show 142 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: February 23, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
 Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on March 01, 2015