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AzTrials

Alzheimer's DiseasePhase 2MAyflOwer RoADNCT01677754

A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy

A Phase 2 study testing RO4602522, Donepezil and Memantine in people with Alzheimer's Disease, run by Hoffmann-La Roche at 142 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
RO4602522, Donepezil and Memantine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
542 participants
Where
142 sitesin 12 countries
Study dates
24 Oct 2012to 12 Jun 2015
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 22Show fewer
  • 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

Trial locations and contacts

142 sites in 12 countries.

142 sites in 12 countries

United States42 sites

  • Albuquerque Neuroscience Inc.

    Albuquerque, New Mexico, 87109

  • Advanced Research Center, Inc.;In-Patient Unit

    Anaheim, California, 92801

  • Parkinson's Disease and Movement Disorders Center of Boca Raton

    Boca Raton, Florida, 33486

  • Meridien Research

    Brooksville, Florida, 34601

  • Alzheimer's Research & Clinical Programs

    Charleston, South Carolina, 29425

  • Millennium Psychiatric Associates, LLC

    Creve Coeur, Missouri, 63141

  • iResearch Atlanta

    Decatur, Georgia, 30030

  • NeuroStudies.net, LLC

    Decatur, Georgia, 30033

  • Brain Matters Research, Inc.

    Delray Beach, Florida, 33445

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Memory Enhancement Center of America, Inc.

    Eatontown, New Jersey, 07724

  • Alexian Brothers Neurosci Inst

    Elk Grove Village, Illinois, 60007

  • Neurologic Consultants, P.A.

    Fort Lauderdale, Florida, 33308

  • University of North Texas Health Science Center

    Fort Worth, Texas, 76107

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Galiz Research, LLC

    Hialeah, Florida, 33016

  • The Clinical Trial Center, LLC

    Jenkintown, Pennsylvania, 19046

  • Torrance Clinical Research

    Lomita, California, 90717

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • Yale University School Of Medicine

    New Haven, Connecticut, 06510

  • Louisiana Research Associates

    New Orleans, Louisiana, 70114

  • New York University Medical Center;Child Study Center

    New York, New York, 10016

  • Research Center for Clinical Studies, Inc.

    Norwalk, Connecticut, 06851

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Cutting Edge Research Group

    Oklahoma City, Oklahoma, 73116

  • Medical Research Group of Central Florida

    Orange City, Florida, 3273

  • Compass Research East, LLC

    Orlando, Florida, 32806

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Raleigh Neurology Associates

    Raleigh, North Carolina, 27607-6520

  • Artemis Institute for Clinical Research, LLC

    San Diego, California, 92103

  • Sharp Mesa Vista Hospital

    San Diego, California, 92123

  • San Francisco Clinical Research Center

    San Francisco, California, 94109

  • Neurological Research Inst

    Santa Monica, California, 90025

  • Booker, J. Gary, MD, APMC

    Shreveport, Louisiana, 71104-2136

  • Comprehensive Clinical Development, Inc.- St. Petersburg, FL

    St. Petersburg, Florida, 33716

  • Richmond Behavioral Associates

    Staten Island, New York, 10312

  • Axiom Clinical Research of Florida

    Tampa, Florida, 33609

  • Northern Michigan Neurology

    Traverse City, Michigan, 49684

  • Premiere Research Institute

    West Palm Beach, Florida, 33407

  • PMG Research of Winston-Salem, LLC

    Winston-Salem, North Carolina, 27103

  • Radiant Research, Inc.

    Wyomissing, Pennsylvania, 19610

Other trials in United States

Canada16 sites

  • Jbn Medical Diagnostic Services Inc.

    Burlington, Ontario, L7M 4Y1

  • Recherches Neuro-Hippocame

    Gatineau, Quebec, J8T 8J1

  • Clinique Neuro Rive-Sud

    Greenfield Park, Quebec, J4V 2J2

  • Capitol District Health Authority

    Halilfax, Nova Scotia, B3H 2E1

  • True North Clinical Research Kentville

    Kentville, Nova Scotia, B4N 4K9

  • Bruyere Continuing Care

    Ottawa, Ontario, K1N 5C8

  • Ingram, Jennifer MD

    Peterborough, Ontario, K9H 3S1

  • The Medical Arts Health Research Group

    Powell River, British Columbia, V8A 3B6

  • CHU de Quebec - Hôpital de l' Enfant Jésus

    Québec, G1J 1Z4

  • Institut Universitaire de gériatrie de Sherbrooke; Service de gériatrie/pavillon Argyll

    Sherbrooke, Quebec, J1J 3H5

  • Toronto Memory Program (Neurology Research Inc.)

    Toronto, Ontario, M3B 2S7

  • The Centre for Memory and Aging

    Toronto, Ontario, M4G 3E8

  • Toronto Sunnybrook Hospital

    Toronto, Ontario, M4N 3M5

  • Vancouver Hospital - UBC Hospital Site

    Vancouver, British Columbia, V6T 2B5

  • McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric

    Verdun, Quebec, H4H 1R3

  • Vancouver Island Health Authority

    Victoria, British Columbia, V8R 1J8

Other trials in Canada

France12 sites

  • Centre Hospitalier de la côte Basque

    Bayonne, 64109

  • Hopital Neurologique Pierre Wertheimer

    Bron, 69500

  • Hopital Nord Laënnec - CHU Nantes

    Nantes, 44093

  • Hopital Cimiez; CMRR

    Nice, 06003

  • Hôpital Lariboisière

    Paris, 75475

  • Groupe Hospitalier Sud - Hôpital Xavier Arnozan

    Pessac, 33604

  • Hôpital Maison Blanche

    Reims, 51092

  • CHU Rennes - Hopital Hôtel Dieu

    Rennes, 35064

  • CHU Toulouse - La Grave

    Toulouse, 31059

  • CHU Tours - Hôpital Bretonneau

    Tours, 37044

  • Hôpital de Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

  • Hopital des Charpennes

    Villeurbanne, 69100

Other trials in France

Spain12 sites

  • Hospital Perpetuo Socorro, Servicio de Geriatria

    Albacete, 2006

  • CAE Oroitu

    Barakaldo, Vizcaya, 48903

  • Fundació ACE

    BArcelon, Barcelona, 08034

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital General Universitario de Elche; Servicio de Farmacia

    Elche, Alicante, 03203

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Virgen del Puerto

    Plasencia, Palencia, 10600

  • Hospital General De Catalunya; Servicio de Neurologia

    Sant Cugat del Vallès, Barcelona, 8195

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41071

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Czechia10 sites

  • NEUROHK s.r.o.

    Choceň, 565 01

  • P-P Klinika

    Kladno, 272 80

  • Supervize s.r.o.

    Kutna Hora - Vnitrni Mesto, 284 01

  • Clintrial,s.r.o.

    Prague, 100 00

  • AD71 s.r.o.

    Prague, 102 00

  • Psychiatry Trial s.r.o.

    Prague, 158 00

  • Neurologicka ambulance

    Prague, 16000

  • FORBELI s.r.o.

    Prague, 165 00

  • Nemocnice Na Bulovce

    Prague, 180 01

  • Thomayerova nemocnice

    Praha 4 - Krc, 140 59

Other trials in Czechia

Australia9 sites

  • Box Hill Hospital; Eastern Clinical Research Unit

    Box Hill, Victoria, 3128

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Central Coast Neurosciences Research

    Erina, New South Wales, 2250

  • A.G.Mander Pty Ltd

    Geelong, Victoria, 3220

  • Heidelberg Repatriation Hospital

    Heidelberg, Victoria, 3084

  • Southern Neurology

    Kogarah, New South Wales, 2217

  • Hollywood Specialist Centre

    Nedlands, Western Australia, 6009

  • Neurodegenerative Disorders Research

    Subiaco, Western Australia, 6008

  • Queen Elizabeth Hospital

    Woodville, South Australia, 5011

Other trials in Australia

Poland9 sites

  • Podlaskie Centrum Psychogeriatrii

    Bialystok, 15-732

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80-214

  • Specjal. Praktyka Lekarska; Prof. Grzegorz Opala

    Katowice, 40-588

  • Centrum Medyczne Dendryt

    Katowice, 40-684

  • NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek

    Poznan, 61-289

  • NZOZ Syntonia

    Pruszcz Gdański, 83-000

  • NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog

    Sopot, 81-717

  • mMED Maciej Czarnecki

    Warsaw, 01-697

  • Instytut Psychiatrii i Neurologii

    Warsaw, 02-957

Other trials in Poland

South Korea9 sites

  • Dong-A University Hospital

    Busan, 49201

  • Seoul National University Bundang Hospital

    Gyeonggi-do, 13620

  • Ajou University Hospital

    Gyeonggi-do, 443-380

  • Inha University Hospital; Pulmonary Medicine

    Incheon, 400-711

  • Kyung Hee University Hospital

    Seoul, 02447

  • Korea University Anam Hospital

    Seoul, 02841

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Konkuk University Medical Center

    Seoul, 05030

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Italy8 sites

  • Ente Ospedaliero Ospedali Galliera

    Genoa, Liguria, 16128

  • Università degli Studi di Genova

    Genoa, Liguria, 16132

  • Nuovo Ospedale Civile S.Agostino - Estense

    Modena, Emilia-Romagna, 41126

  • Università degli studi di Perugia

    Perugia, Umbria, 06126

  • Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica

    Pisa, Tuscany, 56126

  • Policlinico Universitario Agostino Gemelli; Farmacia

    Rome, Lazio, 00168

  • Fondazione Santa Lucia IRCCS

    Rome, Lazio, 00179

  • Umberto I Policlinico di Roma-Università di Roma La Sapienza

    Rome, Lazio, 00185

Other trials in Italy

United Kingdom8 sites

  • Cognitive Treatment & Research Unit

    Crowborough, TN6 1HB

  • Ninewells Hospital

    Dundee, DD12 9SY

  • Glasgow Memory Clinic

    Glasgow, G20 0XA

  • West London Cognitive Disorders Treatment and Research Unit; Lakeside Metal Health Unit

    Isleworth, TW7 6FY

  • Institute of Psychiatry

    London, SE5 8AF

  • Norwich Medical School

    Norwich, NR4 7UY

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Memory Service North

    Sheffield, S35 8QS

Other trials in United Kingdom

Germany5 sites

  • Gemeinschaftspraxis

    Ellwangen, 73479

  • Henriettenstiftung Hannover

    Hanover, 30559

  • ISPG - Institut fuer Studien zur Psychischen Gesundheit

    Mannheim, 68165

  • Klinikum rechts der Isar der Technischen Universität München

    München, 81675

  • Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung

    Siegen, 57072

Other trials in Germany

Sweden2 sites

  • Skanes Universitetssjukhus, Malmo Skanes Universitetssjukhus, Malmo

    Malmö, 205 02

  • Karolinska Universitetssjukhuset Huddinge

    Stockholm, 171 64

Other trials in Sweden

About this study

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

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.

Being tested
RO4602522, Placebo, Donepezil, Memantine, Rivastigmine
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RO4602522Drug

    Participants will receive RO4602522 orally once daily for 12 months.

  • PlaceboDrug

    Participants will receive placebo for RO4602522 orally once daily for 12 months.

  • DonepezilDrug

    Stable dose as background medication

  • MemantineDrug

    Stable dose as background medication in combination with AChEIs

  • RivastigmineDrug

    Stable dose as background medication

  • GalantamineDrug

    Stable dose as background medication

Study groups in NCT01677754
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants will receive placebo as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine.
Receives: Drug: Placebo; Drug: Donepezil; Drug: Memantine; Drug: Rivastigmine; Drug: Galantamine
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.
Receives: Drug: RO4602522; Drug: Donepezil; Drug: Memantine; Drug: Rivastigmine; Drug: Galantamine
RO4602522 5 mgExperimentalParticipants will receive RO4602522 5 mg as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine.
Receives: Drug: RO4602522; Drug: Donepezil; Drug: Memantine; Drug: Rivastigmine; Drug: Galantamine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Behavior Subscale (ADAS-Cog-11) Score at Month 12

    Measured: Baseline, Month 12

Secondary outcomes (18)

  1. Percentage of Participants Achieving Response, Defined as an Increase From Baseline of Less Than or Equal to (<=) 4 Points in ADAS-Cog-11

    Measured: Baseline, Month 12

  2. Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Scale Score at Month 12

    Measured: Baseline, Month 12

  3. Change From Baseline in Behavioral Pathology in Alzheimer's Disease Frequency-Weighted Severity Scale (BEHAVE-AD-FW) Score at Month 12

    Measured: Baseline, Month 12

  4. Percentage of Participants With Worsening in BEHAVE-AD-FW Score

    Measured: Baseline to Month 12

  5. Change From Baseline in Apathy Evaluation Scale (AES) Score at 12 months

    Measured: Baseline, Month 12

  6. Change From Baseline in Alzheimer's Disease Cooperative Study Clinician Global Impression of Change (ADCS-CGIC) Scale Score at 12 months

    Measured: Baseline, Month 12

  7. Percentage of Participants With Worsening in ADCS-CGIC Score

    Measured: Baseline to Month 12

  8. Change From Baseline in Global Deterioration Scale (GDS) Score at 12 months

    Measured: Baseline, Month 12

  9. Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at 12 months

    Measured: Baseline, Month 12

  10. Percentage of Participants with Adverse Events

    Measured: Baseline up to 13 months

  11. Percentage of Participants with Change in Lens Opacity Grading

    Measured: Baseline; Months 6, and 12

  12. Percentage of Participants with Abnormal Visual Acuity Test Results

    Measured: Baseline, Months 6, and 12

  13. Change From Baseline in Michigan Neuropathy Screening Instrument Score

    Measured: Baseline, Weeks 8, 18, 30, 44, 52, and at the last follow-up visit (12 weeks after last dose, up to 64 weeks)

  14. Percentage of Participants Receiving Concomitant Medications

    Measured: Baseline to 13 Months

  15. Apparent Total Clearance of the Drug From Plasma After Administration of RO4602522

    Measured: 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

  16. Apparent Volume of Distribution at Steady State after Administration of RO4602522

    Measured: 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

  17. Area Under the Plasma Concentration-Time Curve of RO4602522

    Measured: 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

  18. Maximum Plasma Concentration of RO4602522

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Sep 2012 (estimated)
  2. Study start24 Oct 2012
  3. Primary completion12 Jun 2015
  4. Study completion12 Jun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
542 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01677754
Sponsor's protocol ID
BP28248
Other IDs
2012-000943-29
Acronym
MAyflOwer RoAD
Status last verified
May 2017
First submitted
30 Aug 2012
Last updated
30 May 2017
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

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.

    PubMed 28550255

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing RO4602522, Donepezil and Memantine in people with Alzheimer's Disease, run by Hoffmann-La Roche at 142 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 142 sites in United States, Canada, France, Spain, Czechia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Behavior Subscale (ADAS-Cog-11) Score at Month 12 (time frame: Baseline, Month 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01677754, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.

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