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

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.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Donepezil; Drug: Memantine; Drug: Rivastigmine; Drug: Galantamine; Drug: RO4602522

• Study Type: Interventional
• Enrollment (Actual): 542
• Phase: Phase 2

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent'S Hospital Sydney
    • Erina, New South Wales, Australia, 2250
      • Central Coast Neurosciences Research
    • Kogarah, New South Wales, Australia, 2217
      • Southern Neurology
  • South Australia
    • Woodville, South Australia, Australia, 5011
      • Queen Elizabeth Hospital
  • Victoria
    • Box Hill, Victoria, Australia, 3128
      • Box Hill Hospital; Eastern Clinical Research Unit
    • Geelong, Victoria, Australia, 3220
      • A.G.Mander Pty Ltd
    • Heidelberg, Victoria, Australia, 3084
      • Heidelberg Repatriation Hospital
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Hollywood Specialist Centre
    • Subiaco, Western Australia, Australia, 6008
      • Neurodegenerative Disorders Research
• Canada
  • Quebec, Canada, G1J 1Z4
    • CHU de Quebec - Hôpital de l' Enfant Jésus
  • British Columbia
    • Powell River, British Columbia, Canada, V8A 3B6
      • The Medical Arts Health Research Group
    • Vancouver, British Columbia, Canada, V6T 2B5
      • Vancouver Hospital - UBC Hospital Site
    • Victoria, British Columbia, Canada, V8R 1J8
      • Vancouver Island Health Authority
  • Nova Scotia
    • Halilfax, Nova Scotia, Canada, B3H 2E1
      • Capitol District Health Authority
    • Kentville, Nova Scotia, Canada, B4N 4K9
      • True North Clinical Research Kentville
  • Ontario
    • Burlington, Ontario, Canada, L7M 4Y1
      • JBN Medical Diagnostic Services Inc.
    • Ottawa, Ontario, Canada, K1N 5C8
      • Bruyere Continuing Care
    • Peterborough, Ontario, Canada, K9H 3S1
      • Ingram, Jennifer MD
    • Toronto, Ontario, Canada, M4N 3M5
      • Toronto Sunnybrook Hospital
    • Toronto, Ontario, Canada, M3B 2S7
      • Toronto Memory Program (Neurology Research Inc.)
    • Toronto, Ontario, Canada, M4G 3E8
      • The Centre for Memory and Aging
  • Quebec
    • Gatineau, Quebec, Canada, J8T 8J1
      • Recherches Neuro-Hippocame
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Clinique Neuro Rive-Sud
    • Sherbrooke, Quebec, Canada, J1J 3H5
      • Institut Universitaire de gériatrie de Sherbrooke; Service de gériatrie/pavillon Argyll
    • Verdun, Quebec, Canada, H4H 1R3
      • McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric
• Czechia
  • Chocen, Czechia, 565 01
    • Neurohk s.r.o.
  • Kladno, Czechia, 272 80
    • P-P Klinika
  • Kutna Hora - Vnitrni Mesto, Czechia, 284 01
    • Supervize s.r.o.
  • Prague, Czechia, 180 01
    • Nemocnice Na Bulovce
  • Praha 10, Czechia, 100 00
    • Clintrial,s.r.o.
  • Praha 10, Czechia, 102 00
    • AD71 s.r.o.
  • Praha 4 - Krc, Czechia, 140 59
    • Thomayerova nemocnice
  • Praha 5, Czechia, 158 00
    • Psychiatry Trial s.r.o.
  • Praha 6, Czechia, 16000
    • Neurologicka ambulance
  • Praha 6, Czechia, 165 00
    • Forbeli s.r.o.
• France
  • Bayonne, France, 64109
    • Centre Hospitalier de la Cote Basque
  • Bron, France, 69500
    • Hôpital Neurologique Pierre Wertheimer
  • Nantes, France, 44093
    • Hôpital Nord Laennec - CHU NANTES
  • Nice, France, 06003
    • Hopital Cimiez; CMRR
  • Paris, France, 75475
    • Hôpital Lariboisière
  • Pessac, France, 33604
    • Groupe Hospitalier Sud - Hôpital Xavier Arnozan
  • Reims, France, 51092
    • Hôpital Maison Blanche
  • Rennes, France, 35064
    • CHU RENNES - Hôpital Hôtel Dieu
  • Toulouse, France, 31059
    • CHU Toulouse - La Grave
  • Tours, France, 37044
    • CHU Tours - Hôpital Bretonneau
  • Vandoeuvre-les-nancy, France, 54511
    • Hôpital de Brabois Adultes
  • Villeurbanne, France, 69100
    • Hôpital des charpennes
• Germany
  • Ellwangen, Germany, 73479
    • Gemeinschaftspraxis
  • Hannover, Germany, 30559
    • Henriettenstiftung Hannover
  • Mannheim, Germany, 68165
    • ISPG - Institut fuer Studien zur Psychischen Gesundheit
  • Munchen, Germany, 81675
    • Klinikum rechts der Isar der Technischen Universitat Munchen
  • Siegen, Germany, 57072
    • Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung
• Italy
  • Emilia-Romagna
    • Modena, Emilia-Romagna, Italy, 41126
      • Nuovo Ospedale Civile S.Agostino - Estense
  • Lazio
    • Roma, Lazio, Italy, 00185
      • Umberto I Policlinico di Roma-Università di Roma La Sapienza
    • Roma, Lazio, Italy, 00168
      • Policlinico Universitario Agostino Gemelli; Farmacia
    • Roma, Lazio, Italy, 00179
      • Fondazione Santa Lucia IRCCS
  • Liguria
    • Genova, Liguria, Italy, 16128
      • Ente Ospedaliero Ospedali Galliera
    • Genova, Liguria, Italy, 16132
      • Università degli Studi di Genova
  • Toscana
    • Pisa, Toscana, Italy, 56126
      • Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica
  • Umbria
    • Perugia, Umbria, Italy, 06126
      • Università degli Studi di Perugia
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Gyeonggi-do, Korea, Republic of, 443-380
    • Ajou University Hospital
  • Gyeonggi-do, Korea, Republic of, 13620
    • Seoul National University Bundang Hospital
  • Incheon, Korea, Republic of, 400-711
    • Inha University Hospital; Pulmonary Medicine
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 02841
    • Korea University Anam Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
• Poland
  • Bialystok, Poland, 15-732
    • Podlaskie Centrum Psychogeriatrii
  • Gdansk, Poland, 80-214
    • Uniwersyteckie Centrum Kliniczne
  • Katowice, Poland, 40-684
    • Centrum Medyczne Dendryt
  • Katowice, Poland, 40-588
    • Specjal. Praktyka Lekarska; Prof. Grzegorz Opala
  • Poznan, Poland, 61-289
    • NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek
  • Pruszcz Gdanski, Poland, 83-000
    • NZOZ Syntonia
  • Sopot, Poland, 81-717
    • NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog
  • Warszawa, Poland, 02-957
    • Instytut Psychiatrii i Neurologii
  • Warszawa, Poland, 01-697
    • mMED Maciej Czarnecki
• Spain
  • Albacete, Spain, 2006
    • Hospital Perpetuo Socorro, Servicio de Geriatria
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28040
    • Hospital Universitario Clinico San Carlos
  • Valencia, Spain, 46026
    • Hospital Universitari I Politecnic La Fe
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche; Servicio de Farmacia
  • Barcelona
    • BArcelon, Barcelona, Spain, 08034
      • Fundacio ACE
    • Sant Cugat del Valles, Barcelona, Spain, 8195
      • Hospital General De Catalunya; Servicio de Neurologia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro Majadahonda
  • Palencia
    • Plasencia, Palencia, Spain, 10600
      • Hospital Virgen del Puerto
  • Sevilla
    • Seville, Sevilla, Spain, 41071
      • Hospital Universitario Virgen Macarena
  • Vizcaya
    • BaraKaldo, Vizcaya, Spain, 48903
      • CAE Oroitu
• Sweden
  • Malmö, Sweden, 205 02
    • Skanes Universitetssjukhus, Malmo Skanes Universitetssjukhus, Malmo
  • Stockholm, Sweden, 171 64
    • Karolinska Universitetssjukhuset Huddinge
• United Kingdom
  • Crowborough, United Kingdom, TN6 1HB
    • Cognitive Treatment & Research Unit
  • Dundee, United Kingdom, DD12 9SY
    • Ninewells Hospital
  • Glasgow, United Kingdom, G20 0XA
    • Glasgow Memory Clinic
  • Isleworth, United Kingdom, TW7 6FY
    • West London Cognitive Disorders Treatment and Research Unit; Lakeside Metal Health Unit
  • London, United Kingdom, SE5 8AF
    • Institute of Psychiatry
  • Norwich, United Kingdom, NR4 7UY
    • Norwich Medical School
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital
  • Sheffield, United Kingdom, S35 8QS
    • Memory Service North
• United States
  • California
    • Anaheim, California, United States, 92801
      • Advanced Research Center, Inc.;In-Patient Unit
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • Lomita, California, United States, 90717
      • Torrance Clinical Research
    • San Diego, California, United States, 92103
      • Artemis Institute for Clinical Research, LLC
    • San Diego, California, United States, 92123
      • Sharp Mesa Vista Hospital
    • San Francisco, California, United States, 94109
      • San Francisco Clinical Research Center
    • Santa Monica, California, United States, 90025
      • Neurological Research Inst
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
    • Norwalk, Connecticut, United States, 06851
      • Research Center for Clinical Studies, Inc.
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Brooksville, Florida, United States, 34601
      • Meridien Research
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research, Inc.
    • Fort Lauderdale, Florida, United States, 33308
      • Neurologic Consultants, P.A.
    • Hialeah, Florida, United States, 33016
      • Galiz Research, LLC
    • Miami, Florida, United States, 33137
      • Miami Jewish Health Systems
    • Orange City, Florida, United States, 3273
      • Medical Research Group of Central Florida
    • Orlando, Florida, United States, 32806
      • Compass Research East, LLC
    • Saint Petersburg, Florida, United States, 33716
      • Comprehensive Clinical Development, Inc.- St. Petersburg, FL
    • Tampa, Florida, United States, 33609
      • Axiom Clinical Research of Florida
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute
  • Georgia
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta
    • Decatur, Georgia, United States, 30033
      • NeuroStudies.net, LLC
  • Illinois
    • Elk Grove Village, Illinois, United States, 60007
      • Alexian Brothers Neurosci Inst
  • Louisiana
    • New Orleans, Louisiana, United States, 70114
      • Louisiana Research Associates
    • Shreveport, Louisiana, United States, 71104-2136
      • Booker, J. Gary, MD, APMC
  • Michigan
    • Traverse City, Michigan, United States, 49684
      • Northern Michigan Neurology
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
  • Missouri
    • Creve Coeur, Missouri, United States, 63141
      • Millennium Psychiatric Associates, LLC
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Memory Enhancement Center of America, Inc.
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience Inc.
  • New York
    • New York, New York, United States, 10016
      • New York University Medical Center;Child Study Center
    • Staten Island, New York, United States, 10312
      • Richmond Behavioral Associates
  • North Carolina
    • Raleigh, North Carolina, United States, 27607-6520
      • Raleigh Neurology Associates
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73116
      • Cutting Edge Research Group
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Pennsylvania
    • Jenkintown, Pennsylvania, United States, 19046
      • The Clinical Trial Center, LLC
    • Wyomissing, Pennsylvania, United States, 19610
      • Radiant Research, Inc.
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Rhode Island Mood & Memory Research Institute
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Alzheimer's Research & Clinical Programs
  • Texas
    • Fort Worth, Texas, United States, 76107
      • University of North Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)
• Requiring nursing home care. Participants living in assisted living facilities are allowed if a reliable caregiver is available (see inclusion criteria)
• Current treatment for Alzheimer's disease other than those listed in inclusion criteria
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Participants will receive placebo as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine.	Drug: Placebo; Participants will receive placebo for RO4602522 orally once daily for 12 months.; Drug: Donepezil; Stable dose as background medication; Drug: Memantine; Stable dose as background medication in combination with AChEIs; Drug: Rivastigmine; Stable dose as background medication; Drug: Galantamine; Stable dose as background medication
Experimental: 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.	Drug: Donepezil; Stable dose as background medication; Drug: Memantine; Stable dose as background medication in combination with AChEIs; Drug: Rivastigmine; Stable dose as background medication; Drug: Galantamine; Stable dose as background medication; Drug: RO4602522; Participants will receive RO4602522 orally once daily for 12 months.
Experimental: 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.	Drug: Donepezil; Stable dose as background medication; Drug: Memantine; Stable dose as background medication in combination with AChEIs; Drug: Rivastigmine; Stable dose as background medication; Drug: Galantamine; Stable dose as background medication; Drug: RO4602522; Participants will receive RO4602522 orally once daily for 12 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Behavior Subscale (ADAS-Cog-11) Score at Month 12	Baseline, Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change From Baseline in Alzheimer's Disease Cooperative Study Clinician Global Impression of Change (ADCS-CGIC) Scale Score at 12 months	Baseline, Month 12
Percentage of Participants With Worsening in ADCS-CGIC Score	Baseline to Month 12
Change From Baseline in Global Deterioration Scale (GDS) Score at 12 months	Baseline, Month 12
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at 12 months	Baseline, Month 12
Percentage of Participants with Adverse Events	Baseline up to 13 months
Percentage of Participants with Change in Lens Opacity Grading	Baseline; Months 6, and 12
Percentage of Participants with Abnormal Visual Acuity Test Results	Baseline, Months 6, and 12
Change From Baseline in Michigan Neuropathy Screening Instrument Score	Baseline, Weeks 8, 18, 30, 44, 52, and at the last follow-up visit (12 weeks after last dose, up to 64 weeks)
Percentage of Participants Receiving Concomitant Medications	Baseline to 13 Months
Apparent Total Clearance of the Drug From Plasma After Administration of RO4602522	Day -1, pre-dose (0 hour) on Days 14, 28, 84, 168, 252, and 364; 1 to 2 hour post dose on Days 14, 84, 252; 2-4 and 5-6 hours post dose on Days 28, 168, and 364
Apparent Volume of Distribution at Steady State after Administration of RO4602522	Day -1, pre-dose (0 hour) on Days 14, 28, 84, 168, 252, and 364; 1 to 2 hour post dose on Days 14, 84, 252; 2-4 and 5-6 hours post dose on Days 28, 168, and 364
Area Under the Plasma Concentration-Time Curve of RO4602522	Day -1, pre-dose (0 hour) on Days 14, 28, 84, 168, 252, and 364; 1 to 2 hour post dose on Days 14, 84, 252; 2-4 and 5-6 hours post dose on Days 28, 168, and 364
Maximum Plasma Concentration of RO4602522	Day -1, pre-dose (0 hour) on Days 14, 28, 84, 168, 252, and 364; 1 to 2 hour post dose on Days 14, 84, 252; 2-4 and 5-6 hours post dose on Days 28, 168, and 364

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2012
• Primary Completion (Actual): June 12, 2015
• Study Completion (Actual): June 12, 2015

Study Registration Dates

• First Submitted: August 30, 2012
• First Submitted That Met QC Criteria: August 30, 2012
• First Posted (Estimate): September 3, 2012

Study Record Updates

• Last Update Posted (Actual): May 30, 2017
• Last Update Submitted That Met QC Criteria: May 25, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Enzyme Inhibitors; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Neuroprotective Agents; Protective Agents; Dopamine Agents; Nootropic Agents; Antiparkinson Agents; Anti-Dyskinesia Agents; Cholinesterase Inhibitors; Parasympathomimetics; Donepezil; Rivastigmine; Memantine; Galantamine
• Other Study ID Numbers: BP28248; 2012-000943-29 (EudraCT Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No