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: August 26, 2014
Last verified: August 2014
  Purpose

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.


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:


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: May 2015
Estimated Primary Completion Date: May 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

  Hide Study Locations
Locations
United States, California
Anaheim, California, United States, 92801
Fullerton, California, United States, 92835
Lomita, California, United States, 90717
San Diego, California, United States, 92123
San Francisco, California, United States, 94109
Santa Monica, California, United States, 90025
United States, Connecticut
New Haven, Connecticut, United States, 06510
Norwalk, Connecticut, United States, 06851
United States, Florida
Boca Raton, Florida, United States, 33486
Brooksville, Florida, United States, 34601
Delray Beach, Florida, United States, 33445
Ft. Lauderdale, Florida, United States, 33308
Miami, Florida, United States, 33137
Miami Springs, Florida, United States, 33166
Orange City, Florida, United States, 3273
Orlando, Florida, United States, 32806
St Petersburg, Florida, United States, 33716
Tampa, Florida, United States, 33609
West Palm Beach, Florida, United States, 33407
United States, Georgia
Decatur, Georgia, United States, 30033
Decatur, Georgia, United States, 30030
United States, Illinois
Elk Grove Village, Illinois, United States, 60007
United States, Louisiana
New Orleans, Louisiana, United States, 70114
Shreveport, Louisiana, United States, 71104-2136
United States, Michigan
Traverse City, Michigan, United States, 49684
United States, Mississippi
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Creve Coeur, Missouri, United States, 63141
United States, New Jersey
Eatontown, New Jersey, United States, 07724
United States, New Mexico
Albuquerque, New Mexico, United States, 87109
United States, New York
New York, New York, United States, 10016
Staten Island, New York, United States, 10312
United States, North Carolina
Raleigh, North Carolina, United States, 27607-6520
Winston-salem, North Carolina, United States, 27103
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
Oklahoma City, Oklahoma, United States, 73116
United States, Pennsylvania
Jenkintown, Pennsylvania, United States, 19046
Wyomissing, Pennsylvania, United States, 19610
United States, Rhode Island
East Providence, Rhode Island, United States, 02914
Providence, Rhode Island, United States, 02903
United States, South Carolina
Charleston, South Carolina, United States, 29425
United States, Texas
Fort Worth, Texas, United States, 76107
Australia, New South Wales
Darlinghurst, New South Wales, Australia, 2010
East Gosford, New South Wales, Australia, 2250
Kogarah, New South Wales, Australia, 2217
Australia, South Australia
Woodville, South Australia, Australia, 5011
Australia, Victoria
Box Hill, Victoria, Australia, 3128
Geelong, Victoria, Australia, 3220
Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
Nedlands, Western Australia, Australia, 6009
Subiaco, Western Australia, Australia, 6008
Canada, British Columbia
Powell River, British Columbia, Canada, V8A 3B6
Vancouver, British Columbia, Canada, V6T 2B5
Victoria, British Columbia, Canada, V8R 1J8
Canada, Nova Scotia
Halilfax, Nova Scotia, Canada, B3H 2E1
Kentville,, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
Burlington, Ontario, Canada, L7M 4Y1
Ottawa, Ontario, Canada, K1N 5C8
Peterborough, Ontario, Canada, K9H 3S1
Toronto, Ontario, Canada, M3B 2S7
Toronto, Ontario, Canada, M6M 3Z5
Toronto, Ontario, Canada, M4N3M5
Canada, Quebec
Gatineau, Quebec, Canada, J8T 8J1
Greenfield Park, Quebec, Canada, J4V 2J2
Sherbrooke, Quebec, Canada, J1J 3H5
Verdun, Quebec, Canada, H4H 1R3
Canada
Quebec, Canada, G1J 1Z4
Czech Republic
Chocen, Czech Republic, 565 01
Kladno, Czech Republic, 272 80
Kutna Hora - Vnitrni Mesto, Czech Republic, 284 01
Praha 10, Czech Republic, 100 00
Praha 10 - Strasnice, Czech Republic, 100 00
Praha 4 - Krc, Czech Republic, 140 59
Praha 5, Czech Republic, 158 00
Praha 6, Czech Republic, 16000
Praha 8, Czech Republic, 180 81
France
Bayonne, France, 64109
Bron, France, 69677
Nantes, France, 44093
Nice, France, 06003
Paris, France, 75475
Pessac, France, 33604
Reims, France, 51092
Rennes, France, 35064
Toulouse, France, 31059
Tours, France, 37044
Vandoeuvre-les-nancy, France, 54511
Villeurbanne, France, 69100
Germany
Ellwangen, Germany, 73479
Hannover, Germany, 30559
Leipzig, Germany, 04107
Mannheim, Germany, 68165
München, Germany, 81675
Siegen, Germany, 57072
Italy
Modena, Emilia-Romagna, Italy, 41126
Roma, Lazio, Italy, 00185
Roma, Lazio, Italy, 00168
Roma, Lazio, Italy, 00179
Genova, Liguria, Italy, 16128
Genova, Liguria, Italy, 16132
Pisa, Toscana, Italy, 56126
Perugia, Umbria, Italy, 06126
Korea, Republic of
Busan, Korea, Republic of, 602-812
Gyeonggi-do, Korea, Republic of, 443-380
Incheon, Korea, Republic of, 400-711
Seongnam-si, Korea, Republic of, 463-707
Seoul, Korea, Republic of, 130-872
Seoul, Korea, Republic of, 120-749
Seoul, Korea, Republic of, 135-710
Seoul, Korea, Republic of, 143-729
Seoul, Korea, Republic of, 136-705
Poland
Bialystok, Poland, 15-732
Gdansk, Poland, 80-214
Gdynia, Poland, 81-361
Gdynia, Poland, 81-423
Katowice, Poland, 40-662
Katowice, Poland, 40-588
Poznan, Poland, 61-289
Warszawa, Poland, 01-697
Warszawa, Poland, 02-957
Spain
Elche, Alicante, Spain, 03203
BArcelon, Barcelona, Spain, 08034
Sant Cugat del Valles, Barcelona, Spain, 8195
Majadahonda, Madrid, Spain, 28222
Plasencia, Palencia, Spain, 10600
Seville, Sevilla, Spain, 41071
BaraKaldo, Vizcaya, Spain, 48903
Albacete, Spain, 2006
Barcelona, Spain, 08041
Madrid, Spain, 28040
Madrid, Spain, 28031
Valencia, Spain, 46026
Sweden
Malmö, Sweden, 205 02
Stockholm, Sweden, 17164
United Kingdom
Crowborough, United Kingdom, TN6 1HB
Dundee, United Kingdom, DD12 9SY
Glasgow, United Kingdom, G20 0XA
Isleworth, United Kingdom, TW7 6FY
London, United Kingdom, SE5 8AF
Norwich, United Kingdom, NR4 7UY
Plymouth, United Kingdom, PL6 8BX
Sheffield, United Kingdom, S35 8QS
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: August 26, 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
Rivastigmine
Cholinesterase Inhibitors
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

ClinicalTrials.gov processed this record on September 18, 2014