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

May 25, 2017 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
542

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Bruyère 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
        • Hopital Nord Laennec - CHU NANTES
      • Nice, France, 06003
        • Hopital Cimiez; CMRR
      • Paris, France, 75475
        • Hopital Lariboisiere
      • Pessac, France, 33604
        • Groupe Hospitalier Sud - Hôpital Xavier Arnozan
      • Reims, France, 51092
        • Hopital 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
        • Hopital 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 Universität München
      • 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 Clínico 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
        • Fundació 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Behavior Subscale (ADAS-Cog-11) Score at Month 12
Time Frame: Baseline, Month 12
Baseline, Month 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: Baseline, Month 12
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
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
Baseline, Month 12
Percentage of Participants With Worsening in BEHAVE-AD-FW Score
Time Frame: Baseline to Month 12
Baseline to Month 12
Change From Baseline in Apathy Evaluation Scale (AES) Score at 12 months
Time Frame: Baseline, Month 12
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
Baseline, Month 12
Percentage of Participants With Worsening in ADCS-CGIC Score
Time Frame: Baseline to Month 12
Baseline to Month 12
Change From Baseline in Global Deterioration Scale (GDS) Score at 12 months
Time Frame: Baseline, Month 12
Baseline, Month 12
Change From Baseline in Columbia Suicide Severity Rating Scale (C-SSRS) Score at 12 months
Time Frame: Baseline, Month 12
Baseline, Month 12
Percentage of Participants with Adverse Events
Time Frame: Baseline up to 13 months
Baseline up to 13 months
Percentage of Participants with Change in Lens Opacity Grading
Time Frame: Baseline; Months 6, and 12
Baseline; Months 6, and 12
Percentage of Participants with Abnormal Visual Acuity Test Results
Time Frame: Baseline, Months 6, and 12
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)
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
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
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
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
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
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 24, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 12, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 30, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 30, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 3, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 25, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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