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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: November 3, 2014
Last verified: November 2014

August 30, 2012
November 3, 2014
November 2012
June 2015   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01677754 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
MAyflOwer RoAD Study: A Study of RO4602522 in Patients With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy
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

This phase II, multicenter, randomized, double-blind, parallel-group, placebo-co ntrolled study will evaluate the efficacy and safety of RO4602522 in patients wi th moderate severity Alzheimer disease. Patients who are taking background thera py 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.

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: 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
  • Drug: RO4601522
    Dose B, 12 months
  • Drug: RO4602522
    Dose A, 12 months
  • Placebo Comparator: Placebo
    Interventions:
    • Drug: donepezil
    • Drug: galantamine
    • Drug: memantine
    • Drug: placebo
    • Drug: rivastigmine
  • Experimental: RO4602522 Dose A
    Interventions:
    • Drug: donepezil
    • Drug: galantamine
    • Drug: memantine
    • Drug: rivastigmine
    • Drug: RO4602522
  • Experimental: RO4602522 Dose B
    Interventions:
    • Drug: donepezil
    • Drug: galantamine
    • Drug: memantine
    • Drug: rivastigmine
    • Drug: RO4601522
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
544
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Canada,   Czech Republic,   France,   Germany,   Italy,   Korea, Republic of,   Poland,   Spain,   Sweden,   United Kingdom
 
NCT01677754
BP28248
Not Provided
Hoffmann-La Roche
Hoffmann-La Roche
Not Provided
Study Director: Clinical Trials Hoffmann-La Roche
Hoffmann-La Roche
November 2014

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