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A Study of RO4602522 in Participants With Moderate Severity Alzheimer Disease on Background Alzheimer Disease Therapy (MAyflOwer RoAD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01677754
First received: August 30, 2012
Last updated: May 25, 2017
Last verified: May 2017
  Purpose
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.

Condition Intervention Phase
Alzheimer's Disease Drug: RO4602522 Drug: Placebo Drug: Donepezil Drug: Memantine Drug: Rivastigmine Drug: Galantamine Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Behavior Subscale (ADAS-Cog-11) Score at Month 12 [ Time Frame: Baseline, Month 12 ]

Secondary Outcome Measures:
  • Percentage of Participants Achieving Response, Defined as an Increase From Baseline of Less Than or Equal to (<=) 4 Points in ADAS-Cog-11 [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Scale Score at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in Behavioral Pathology in Alzheimer's Disease Frequency-Weighted Severity Scale (BEHAVE-AD-FW) Score at Month 12 [ Time Frame: Baseline, Month 12 ]
  • Percentage of Participants With Worsening in BEHAVE-AD-FW Score [ Time Frame: Baseline to Month 12 ]
  • Change From Baseline in Apathy Evaluation Scale (AES) Score at 12 months [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in Alzheimer's Disease Cooperative Study Clinician Global Impression of Change (ADCS-CGIC) Scale Score at 12 months [ Time Frame: Baseline, Month 12 ]
  • Percentage of Participants With Worsening in ADCS-CGIC Score [ Time Frame: Baseline to Month 12 ]
  • Change From Baseline in Global Deterioration Scale (GDS) Score at 12 months [ Time Frame: Baseline, Month 12 ]
  • Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at 12 months [ Time Frame: Baseline, Month 12 ]
  • Percentage of Participants with Adverse Events [ Time Frame: Baseline up to 13 months ]
  • Percentage of Participants with Change in Lens Opacity Grading [ Time Frame: Baseline; Months 6, and 12 ]
  • Percentage of Participants with Abnormal Visual Acuity Test Results [ Time Frame: Baseline, Months 6, and 12 ]
  • Change From Baseline in Michigan Neuropathy Screening Instrument Score [ Time Frame: 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 [ Time Frame: Baseline to 13 Months ]
  • Apparent Total Clearance of the Drug From Plasma After Administration of RO4602522 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 ]

Enrollment: 542
Actual Study Start Date: October 24, 2012
Study Completion Date: June 12, 2015
Primary Completion Date: June 12, 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: RO4602522
Participants will receive 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 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: RO4602522
Participants will receive 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

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01677754     History of Changes
Other Study ID Numbers: BP28248
2012-000943-29 ( EudraCT Number )
Study First Received: August 30, 2012
Last Updated: May 25, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Galantamine
Rivastigmine
Memantine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Parasympathomimetics
Autonomic Agents
Peripheral Nervous System Agents
Neuroprotective Agents
Protective Agents

ClinicalTrials.gov processed this record on August 18, 2017