A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy
MAyflOwer RoAD
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
2 other identifiers
interventional
542
12 countries
142
Brief Summary
This Phase II, multicenter, randomized, double-blind, parallel-group, placebo-controlled study will evaluate the efficacy and safety of RO4602522 in participants with moderate severity Alzheimer's disease. Participants who are taking background therapy of acetylcholinesterase inhibitors (AChEI) 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2012
142 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2012
CompletedFirst Posted
Study publicly available on registry
September 3, 2012
CompletedStudy Start
First participant enrolled
October 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 12, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2015
CompletedMay 30, 2017
May 1, 2017
2.6 years
August 30, 2012
May 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Behavior Subscale (ADAS-Cog-11) Score at Month 12
Baseline, Month 12
Secondary Outcomes (18)
Percentage of Participants Achieving Response, Defined as an Increase From Baseline of Less Than or Equal to (<=) 4 Points in ADAS-Cog-11
Baseline, Month 12
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Scale Score at Month 12
Baseline, Month 12
Change From Baseline in Behavioral Pathology in Alzheimer's Disease Frequency-Weighted Severity Scale (BEHAVE-AD-FW) Score at Month 12
Baseline, Month 12
Percentage of Participants With Worsening in BEHAVE-AD-FW Score
Baseline to Month 12
Change From Baseline in Apathy Evaluation Scale (AES) Score at 12 months
Baseline, Month 12
- +13 more secondary outcomes
Study Arms (3)
Placebo
PLACEBO COMPARATORParticipants will receive placebo as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine.
RO4602522 1 milligram (mg)
EXPERIMENTALParticipants will receive RO4602522 1 mg as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine.
RO4602522 5 mg
EXPERIMENTALParticipants will receive RO4602522 5 mg as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine.
Interventions
Eligibility Criteria
You may qualify if:
- 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 Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition (DSM-IV-TR) criteria
- Mini-Mental State Exam (MMSE) score at screening between 13 and 20, inclusive
- Body mass index (BMI) between 18 and 36 kilograms per square meter (kg/m\^2) (inclusive) at screening
- Modified Hachinski Ischemia Score of less than or equal to (\</=) 4
- Participants with Cornell Scale for Depression in Dementia (CSDD) scores \</= 13 at screening
- Receiving treatment with donepezil, rivastigmine, galantamine or any 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 participant
You may not qualify if:
- Any neurological or psychiatric condition that may occur currently or during the course of the study that can 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 regardless of whether or not the participant is taking antihypertensive medications
- 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 participant
- Inadequate hepatic, renal or thyroid function
- Positive for hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection
- Poorly controlled diabetes (glycosylated hemoglobin \[HbA1c\] greater than or equal to \[\>/=\] 9 percent at screening)
- Participation at any time in an active Alzheimer's disease vaccine study
- Recent (\</= 12 weeks) or concomitant use of other Monoamine oxidase inhibitors (selective or not) including selegiline or rasagiline
- Antidepressant treatments are not allowed except for citalopram up to 20 mg daily, escitalopram up to 10 mg daily, paroxetine up to 30 mg daily, sertraline up to 100 mg daily and trazodone up to 100 mg daily. If treated with one of these antidepressants, the treatment should be present for at least 6 weeks at screening. All other antidepressants including other SSRIs, tricyclic antidepressants (TCAs), serotonin-norepinephrine reuptake inhibitors (SNRIs), St. John's wort and bupropion are excluded
- Anti-psychotic use within 4 weeks before screening is not permitted except risperidone up to 1.5 mg/day, quetiapine up to 100 milligrams per day (mg/day), olanzapine up to 5 mg/day, and aripiprazole up to 10 mg daily
- Anxiolytics/ hypnotics use is not permitted except for benzodiazepines of short or intermediate half-life for anxiety/sleeping disorders. Zolpidem (up to 5 mg/day), zopiclone (up to 7.5 mg/day), eszopiclone (up to 2 mg/day), trazodone (up to 50 mg/day, at bedtime) or zaleplon (up to 5 mg/day) is permitted for insomnia
- Anti-Parkinson's agents within 2 weeks before screening are not permitted
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (142)
Advanced Research Center, Inc.;In-Patient Unit
Anaheim, California, 92801, United States
Neurology Center of North Orange County
Fullerton, California, 92835, United States
Torrance Clinical Research
Lomita, California, 90717, United States
Artemis Institute for Clinical Research, LLC
San Diego, California, 92103, United States
Sharp Mesa Vista Hospital
San Diego, California, 92123, United States
San Francisco Clinical Research Center
San Francisco, California, 94109, United States
Neurological Research Inst
Santa Monica, California, 90025, United States
Yale University School Of Medicine
New Haven, Connecticut, 06510, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, 06851, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, 33486, United States
Meridien Research
Brooksville, Florida, 34601, United States
Brain Matters Research, Inc.
Delray Beach, Florida, 33445, United States
Neurologic Consultants, P.A.
Fort Lauderdale, Florida, 33308, United States
Galiz Research, LLC
Hialeah, Florida, 33016, United States
Miami Jewish Health Systems
Miami, Florida, 33137, United States
Medical Research Group of Central Florida
Orange City, Florida, 3273, United States
Compass Research East, LLC
Orlando, Florida, 32806, United States
Comprehensive Clinical Development, Inc.- St. Petersburg, FL
St. Petersburg, Florida, 33716, United States
Axiom Clinical Research of Florida
Tampa, Florida, 33609, United States
Premiere Research Institute
West Palm Beach, Florida, 33407, United States
iResearch Atlanta
Decatur, Georgia, 30030, United States
NeuroStudies.net, LLC
Decatur, Georgia, 30033, United States
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, 60007, United States
Louisiana Research Associates
New Orleans, Louisiana, 70114, United States
Booker, J. Gary, MD, APMC
Shreveport, Louisiana, 71104-2136, United States
Northern Michigan Neurology
Traverse City, Michigan, 49684, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, 39401, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, 63141, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, 07724, United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, 87109, United States
New York University Medical Center;Child Study Center
New York, New York, 10016, United States
Richmond Behavioral Associates
Staten Island, New York, 10312, United States
Raleigh Neurology Associates
Raleigh, North Carolina, 27607-6520, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, 27103, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, 73116, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, 19046, United States
Radiant Research, Inc.
Wyomissing, Pennsylvania, 19610, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, 02914, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Alzheimer's Research & Clinical Programs
Charleston, South Carolina, 29425, United States
University of North Texas Health Science Center
Fort Worth, Texas, 76107, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Central Coast Neurosciences Research
Erina, New South Wales, 2250, Australia
Southern Neurology
Kogarah, New South Wales, 2217, Australia
Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
Box Hill Hospital; Eastern Clinical Research Unit
Box Hill, Victoria, 3128, Australia
A.G.Mander Pty Ltd
Geelong, Victoria, 3220, Australia
Heidelberg Repatriation Hospital
Heidelberg, Victoria, 3084, Australia
Hollywood Specialist Centre
Nedlands, Western Australia, 6009, Australia
Neurodegenerative Disorders Research
Subiaco, Western Australia, 6008, Australia
The Medical Arts Health Research Group
Powell River, British Columbia, V8A 3B6, Canada
Vancouver Hospital - UBC Hospital Site
Vancouver, British Columbia, V6T 2B5, Canada
Vancouver Island Health Authority
Victoria, British Columbia, V8R 1J8, Canada
Capitol District Health Authority
Halilfax, Nova Scotia, B3H 2E1, Canada
True North Clinical Research Kentville
Kentville, Nova Scotia, B4N 4K9, Canada
Jbn Medical Diagnostic Services Inc.
Burlington, Ontario, L7M 4Y1, Canada
Bruyere Continuing Care
Ottawa, Ontario, K1N 5C8, Canada
Ingram, Jennifer MD
Peterborough, Ontario, K9H 3S1, Canada
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, M3B 2S7, Canada
The Centre for Memory and Aging
Toronto, Ontario, M4G 3E8, Canada
Toronto Sunnybrook Hospital
Toronto, Ontario, M4N 3M5, Canada
Recherches Neuro-Hippocame
Gatineau, Quebec, J8T 8J1, Canada
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, J4V 2J2, Canada
Institut Universitaire de gériatrie de Sherbrooke; Service de gériatrie/pavillon Argyll
Sherbrooke, Quebec, J1J 3H5, Canada
McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
Verdun, Quebec, H4H 1R3, Canada
CHU de Quebec - Hôpital de l' Enfant Jésus
Québec, G1J 1Z4, Canada
NEUROHK s.r.o.
Choceň, 565 01, Czechia
P-P Klinika
Kladno, 272 80, Czechia
Supervize s.r.o.
Kutna Hora - Vnitrni Mesto, 284 01, Czechia
Clintrial,s.r.o.
Prague, 100 00, Czechia
AD71 s.r.o.
Prague, 102 00, Czechia
Psychiatry Trial s.r.o.
Prague, 158 00, Czechia
Neurologicka ambulance
Prague, 16000, Czechia
FORBELI s.r.o.
Prague, 165 00, Czechia
Nemocnice Na Bulovce
Prague, 180 01, Czechia
Thomayerova nemocnice
Praha 4 - Krc, 140 59, Czechia
Centre Hospitalier de la côte Basque
Bayonne, 64109, France
Hopital Neurologique Pierre Wertheimer
Bron, 69500, France
Hopital Nord Laënnec - CHU Nantes
Nantes, 44093, France
Hopital Cimiez; CMRR
Nice, 06003, France
Hôpital Lariboisière
Paris, 75475, France
Groupe Hospitalier Sud - Hôpital Xavier Arnozan
Pessac, 33604, France
Hôpital Maison Blanche
Reims, 51092, France
CHU Rennes - Hopital Hôtel Dieu
Rennes, 35064, France
CHU Toulouse - La Grave
Toulouse, 31059, France
CHU Tours - Hôpital Bretonneau
Tours, 37044, France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, 54511, France
Hopital des Charpennes
Villeurbanne, 69100, France
Gemeinschaftspraxis
Ellwangen, 73479, Germany
Henriettenstiftung Hannover
Hanover, 30559, Germany
ISPG - Institut fuer Studien zur Psychischen Gesundheit
Mannheim, 68165, Germany
Klinikum rechts der Isar der Technischen Universität München
München, 81675, Germany
Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
Siegen, 57072, Germany
Nuovo Ospedale Civile S.Agostino - Estense
Modena, Emilia-Romagna, 41126, Italy
Policlinico Universitario Agostino Gemelli; Farmacia
Rome, Lazio, 00168, Italy
Fondazione Santa Lucia IRCCS
Rome, Lazio, 00179, Italy
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Rome, Lazio, 00185, Italy
Ente Ospedaliero Ospedali Galliera
Genoa, Liguria, 16128, Italy
Università degli Studi di Genova
Genoa, Liguria, 16132, Italy
Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica
Pisa, Tuscany, 56126, Italy
Università degli studi di Perugia
Perugia, Umbria, 06126, Italy
Podlaskie Centrum Psychogeriatrii
Bialystok, 15-732, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80-214, Poland
Specjal. Praktyka Lekarska; Prof. Grzegorz Opala
Katowice, 40-588, Poland
Centrum Medyczne Dendryt
Katowice, 40-684, Poland
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
Poznan, 61-289, Poland
NZOZ Syntonia
Pruszcz Gdański, 83-000, Poland
NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog
Sopot, 81-717, Poland
mMED Maciej Czarnecki
Warsaw, 01-697, Poland
Instytut Psychiatrii i Neurologii
Warsaw, 02-957, Poland
Dong-A University Hospital
Busan, 49201, South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, 13620, South Korea
Ajou University Hospital
Gyeonggi-do, 443-380, South Korea
Inha University Hospital; Pulmonary Medicine
Incheon, 400-711, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Korea University Anam Hospital
Seoul, 02841, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Konkuk University Medical Center
Seoul, 05030, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Hospital General Universitario de Elche; Servicio de Farmacia
Elche, Alicante, 03203, Spain
Fundació ACE
BArcelon, Barcelona, 08034, Spain
Hospital General De Catalunya; Servicio de Neurologia
Sant Cugat del Vallès, Barcelona, 8195, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222, Spain
Hospital Virgen del Puerto
Plasencia, Palencia, 10600, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, 41071, Spain
CAE Oroitu
Barakaldo, Vizcaya, 48903, Spain
Hospital Perpetuo Socorro, Servicio de Geriatria
Albacete, 2006, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08041, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Skanes Universitetssjukhus, Malmo Skanes Universitetssjukhus, Malmo
Malmo, 205 02, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, 171 64, Sweden
Cognitive Treatment & Research Unit
Crowborough, TN6 1HB, United Kingdom
Ninewells Hospital
Dundee, DD12 9SY, United Kingdom
Glasgow Memory Clinic
Glasgow, G20 0XA, United Kingdom
West London Cognitive Disorders Treatment and Research Unit; Lakeside Metal Health Unit
Isleworth, TW7 6FY, United Kingdom
Institute of Psychiatry
London, SE5 8AF, United Kingdom
Norwich Medical School
Norwich, NR4 7UY, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Memory Service North
Sheffield, S35 8QS, United Kingdom
Related Publications (1)
Nave S, Doody RS, Boada M, Grimmer T, Savola JM, Delmar P, Pauly-Evers M, Nikolcheva T, Czech C, Borroni E, Ricci B, Dukart J, Mannino M, Carey T, Moran E, Gilaberte I, Muelhardt NM, Gerlach I, Santarelli L, Ostrowitzki S, Fontoura P. Sembragiline in Moderate Alzheimer's Disease: Results of a Randomized, Double-Blind, Placebo-Controlled Phase II Trial (MAyflOwer RoAD). J Alzheimers Dis. 2017;58(4):1217-1228. doi: 10.3233/JAD-161309.
PMID: 28550255DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2012
First Posted
September 3, 2012
Study Start
October 24, 2012
Primary Completion
June 12, 2015
Study Completion
June 12, 2015
Last Updated
May 30, 2017
Record last verified: 2017-05