A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy
NCT ID: NCT01677754
Last Updated: 2017-05-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
542 participants
INTERVENTIONAL
2012-10-24
2015-06-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Placebo
Participants will receive placebo as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine.
Placebo
Participants will receive placebo for RO4602522 orally once daily for 12 months.
Donepezil
Stable dose as background medication
Memantine
Stable dose as background medication in combination with AChEIs
Rivastigmine
Stable dose as background medication
Galantamine
Stable dose as background medication
RO4602522 1 milligram (mg)
Participants 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
Participants will receive RO4602522 orally once daily for 12 months.
Donepezil
Stable dose as background medication
Memantine
Stable dose as background medication in combination with AChEIs
Rivastigmine
Stable dose as background medication
Galantamine
Stable dose as background medication
RO4602522 5 mg
Participants will receive RO4602522 5 mg as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine.
RO4602522
Participants will receive RO4602522 orally once daily for 12 months.
Donepezil
Stable dose as background medication
Memantine
Stable dose as background medication in combination with AChEIs
Rivastigmine
Stable dose as background medication
Galantamine
Stable dose as background medication
Interventions
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RO4602522
Participants will receive RO4602522 orally once daily for 12 months.
Placebo
Participants will receive placebo for RO4602522 orally once daily for 12 months.
Donepezil
Stable dose as background medication
Memantine
Stable dose as background medication in combination with AChEIs
Rivastigmine
Stable dose as background medication
Galantamine
Stable dose as background medication
Eligibility Criteria
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Inclusion 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
* Participation at any time in an active Alzheimer's disease vaccine study
* Participation in a passive Alzheimer's disease immunization study less than 1 year before screening except for a) participants where documented medical history indicate that they were randomized to the placebo group in these studies, b) participants treated with bapineuzumab where a 6-month exclusion period applies
* 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
* Recent (less than 4 weeks prior to screening) or concomitant use of anticonvulsants
* Anticholinergics/ antihistaminics within 2 weeks before screening are not permitted, except i) if used episodically more than 3 days before the screening cognitive measurement, ii) non-sedating antihistaminic medications (without anticholinergic effects such as cetirizine) or peripheral anticholinergics without central anticholinergic effects (such as, trospium for the treatment of hyperactive bladder), which are permitted
* Recent (less than 1 week prior to screening) or concomitant use of opioid drugs (tramadol, methadone, propoxyphene, or meperidine), cyclobenzaprine and dextromethorphan
* Concomitant use of sympathomimetic drugs, including sympathomimetics in local anesthetics and ephedra supplements
Exclusion Criteria
* 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)
50 Years
90 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Advanced Research Center, Inc.;In-Patient Unit
Anaheim, California, United States
Neurology Center of North Orange County
Fullerton, California, United States
Torrance Clinical Research
Lomita, California, United States
Artemis Institute for Clinical Research, LLC
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
San Francisco Clinical Research Center
San Francisco, California, United States
Neurological Research Inst
Santa Monica, California, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Meridien Research
Brooksville, Florida, United States
Brain Matters Research, Inc.
Delray Beach, Florida, United States
Neurologic Consultants, P.A.
Fort Lauderdale, Florida, United States
Galiz Research, LLC
Hialeah, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Compass Research East, LLC
Orlando, Florida, United States
Comprehensive Clinical Development, Inc.- St. Petersburg, FL
St. Petersburg, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
iResearch Atlanta
Decatur, Georgia, United States
NeuroStudies.net, LLC
Decatur, Georgia, United States
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, United States
Louisiana Research Associates
New Orleans, Louisiana, United States
Booker, J. Gary, MD, APMC
Shreveport, Louisiana, United States
Northern Michigan Neurology
Traverse City, Michigan, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Millennium Psychiatric Associates, LLC
Creve Coeur, Missouri, United States
Memory Enhancement Center of America, Inc.
Eatontown, New Jersey, United States
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico, United States
New York University Medical Center;Child Study Center
New York, New York, United States
Richmond Behavioral Associates
Staten Island, New York, United States
Raleigh Neurology Associates
Raleigh, North Carolina, United States
PMG Research of Winston-Salem, LLC
Winston-Salem, North Carolina, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Cutting Edge Research Group
Oklahoma City, Oklahoma, United States
The Clinical Trial Center, LLC
Jenkintown, Pennsylvania, United States
Radiant Research, Inc.
Wyomissing, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Alzheimer's Research & Clinical Programs
Charleston, South Carolina, United States
University of North Texas Health Science Center
Fort Worth, Texas, United States
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Central Coast Neurosciences Research
Erina, New South Wales, Australia
Southern Neurology
Kogarah, New South Wales, Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia
Box Hill Hospital; Eastern Clinical Research Unit
Box Hill, Victoria, Australia
A.G.Mander Pty Ltd
Geelong, Victoria, Australia
Heidelberg Repatriation Hospital
Heidelberg, Victoria, Australia
Hollywood Specialist Centre
Nedlands, Western Australia, Australia
Neurodegenerative Disorders Research
Subiaco, Western Australia, Australia
The Medical Arts Health Research Group
Powell River, British Columbia, Canada
Vancouver Hospital - UBC Hospital Site
Vancouver, British Columbia, Canada
Vancouver Island Health Authority
Victoria, British Columbia, Canada
Capitol District Health Authority
Halilfax, Nova Scotia, Canada
True North Clinical Research Kentville
Kentville, Nova Scotia, Canada
Jbn Medical Diagnostic Services Inc.
Burlington, Ontario, Canada
Bruyere Continuing Care
Ottawa, Ontario, Canada
Ingram, Jennifer MD
Peterborough, Ontario, Canada
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, Canada
The Centre for Memory and Aging
Toronto, Ontario, Canada
Toronto Sunnybrook Hospital
Toronto, Ontario, Canada
Recherches Neuro-Hippocame
Gatineau, Quebec, Canada
Clinique Neuro Rive-Sud
Greenfield Park, Quebec, Canada
Institut Universitaire de gériatrie de Sherbrooke; Service de gériatrie/pavillon Argyll
Sherbrooke, Quebec, Canada
McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
Verdun, Quebec, Canada
CHU de Quebec - Hôpital de l' Enfant Jésus
Québec, , Canada
NEUROHK s.r.o.
Choceň, , Czechia
P-P Klinika
Kladno, , Czechia
Supervize s.r.o.
Kutna Hora - Vnitrni Mesto, , Czechia
Clintrial,s.r.o.
Prague, , Czechia
AD71 s.r.o.
Prague, , Czechia
Psychiatry Trial s.r.o.
Prague, , Czechia
Neurologicka ambulance
Prague, , Czechia
FORBELI s.r.o.
Prague, , Czechia
Nemocnice Na Bulovce
Prague, , Czechia
Thomayerova nemocnice
Praha 4 - Krc, , Czechia
Centre Hospitalier de la côte Basque
Bayonne, , France
Hopital Neurologique Pierre Wertheimer
Bron, , France
Hopital Nord Laënnec - CHU Nantes
Nantes, , France
Hopital Cimiez; CMRR
Nice, , France
Hôpital Lariboisière
Paris, , France
Groupe Hospitalier Sud - Hôpital Xavier Arnozan
Pessac, , France
Hôpital Maison Blanche
Reims, , France
CHU Rennes - Hopital Hôtel Dieu
Rennes, , France
CHU Toulouse - La Grave
Toulouse, , France
CHU Tours - Hôpital Bretonneau
Tours, , France
Hôpital de Brabois Adultes
Vandœuvre-lès-Nancy, , France
Hopital des Charpennes
Villeurbanne, , France
Gemeinschaftspraxis
Ellwangen, , Germany
Henriettenstiftung Hannover
Hanover, , Germany
ISPG - Institut fuer Studien zur Psychischen Gesundheit
Mannheim, , Germany
Klinikum rechts der Isar der Technischen Universität München
München, , Germany
Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
Siegen, , Germany
Nuovo Ospedale Civile S.Agostino - Estense
Modena, Emilia-Romagna, Italy
Policlinico Universitario Agostino Gemelli; Farmacia
Rome, Lazio, Italy
Fondazione Santa Lucia IRCCS
Rome, Lazio, Italy
Umberto I Policlinico di Roma-Università di Roma La Sapienza
Rome, Lazio, Italy
Ente Ospedaliero Ospedali Galliera
Genoa, Liguria, Italy
Università degli Studi di Genova
Genoa, Liguria, Italy
Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica
Pisa, Tuscany, Italy
Università degli studi di Perugia
Perugia, Umbria, Italy
Podlaskie Centrum Psychogeriatrii
Bialystok, , Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, , Poland
Specjal. Praktyka Lekarska; Prof. Grzegorz Opala
Katowice, , Poland
Centrum Medyczne Dendryt
Katowice, , Poland
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
Poznan, , Poland
NZOZ Syntonia
Pruszcz Gdański, , Poland
NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog
Sopot, , Poland
mMED Maciej Czarnecki
Warsaw, , Poland
Instytut Psychiatrii i Neurologii
Warsaw, , Poland
Dong-A University Hospital
Busan, , South Korea
Seoul National University Bundang Hospital
Gyeonggi-do, , South Korea
Ajou University Hospital
Gyeonggi-do, , South Korea
Inha University Hospital; Pulmonary Medicine
Incheon, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Konkuk University Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Hospital General Universitario de Elche; Servicio de Farmacia
Elche, Alicante, Spain
Fundació ACE
BArcelon, Barcelona, Spain
Hospital General De Catalunya; Servicio de Neurologia
Sant Cugat del Vallès, Barcelona, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Virgen del Puerto
Plasencia, Palencia, Spain
Hospital Universitario Virgen Macarena
Seville, Sevilla, Spain
CAE Oroitu
Barakaldo, Vizcaya, Spain
Hospital Perpetuo Socorro, Servicio de Geriatria
Albacete, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Skanes Universitetssjukhus, Malmo Skanes Universitetssjukhus, Malmo
Malmo, , Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm, , Sweden
Cognitive Treatment & Research Unit
Crowborough, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Glasgow Memory Clinic
Glasgow, , United Kingdom
West London Cognitive Disorders Treatment and Research Unit; Lakeside Metal Health Unit
Isleworth, , United Kingdom
Institute of Psychiatry
London, , United Kingdom
Norwich Medical School
Norwich, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Memory Service North
Sheffield, , United Kingdom
Countries
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References
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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.
Other Identifiers
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2012-000943-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BP28248
Identifier Type: -
Identifier Source: org_study_id
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