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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-000943-29 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants will receive placebo as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine. |
|
| RO4602522 1 milligram (mg) | Experimental | Participants will receive RO4602522 1 mg as add-on to a background therapy of AChEI (donepezil, rivastigmine, or galantamine) alone or in combination with memantine. |
|
| RO4602522 5 mg | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RO4602522 | Drug | Participants will receive RO4602522 orally once daily for 12 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Alzheimer's Disease Assessment Scale - Cognitive Behavior Subscale (ADAS-Cog-11) Score at Month 12 | Baseline, Month 12 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Research Center, Inc.;In-Patient Unit | Anaheim | California | 92801 | United States | ||
| Neurology Center of North Orange County |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28550255 | Derived | 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. |
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| Placebo | Drug | Participants will receive placebo for RO4602522 orally once daily for 12 months. |
|
| Donepezil | Drug | Stable dose as background medication |
|
| Memantine | Drug | Stable dose as background medication in combination with AChEIs |
|
| Rivastigmine | Drug | Stable dose as background medication |
|
| Galantamine | Drug | Stable dose as background medication |
|
| 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 |
| Fullerton |
| California |
| 92835 |
| United States |
| Torrance Clinical Research | Lomita | California | 90717 | United States |
| Artemis Institute for Clinical Research, LLC | San Diego | California | 92103 | United States |
| Sharp Mesa Vista Hospital | San Diego | California | 92123 | United States |
| San Francisco Clinical Research Center | San Francisco | California | 94109 | United States |
| Neurological Research Inst | Santa Monica | California | 90025 | United States |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | United States |
| Research Center for Clinical Studies, Inc. | Norwalk | Connecticut | 06851 | United States |
| Parkinson's Disease and Movement Disorders Center of Boca Raton | Boca Raton | Florida | 33486 | United States |
| Meridien Research | Brooksville | Florida | 34601 | United States |
| Brain Matters Research, Inc. | Delray Beach | Florida | 33445 | United States |
| Neurologic Consultants, P.A. | Fort Lauderdale | Florida | 33308 | United States |
| Galiz Research, LLC | Hialeah | Florida | 33016 | United States |
| Miami Jewish Health Systems | Miami | Florida | 33137 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 3273 | United States |
| Compass Research East, LLC | Orlando | Florida | 32806 | United States |
| Comprehensive Clinical Development, Inc.- St. Petersburg, FL | St. Petersburg | Florida | 33716 | United States |
| Axiom Clinical Research of Florida | Tampa | Florida | 33609 | United States |
| Premiere Research Institute | West Palm Beach | Florida | 33407 | United States |
| iResearch Atlanta | Decatur | Georgia | 30030 | United States |
| NeuroStudies.net, LLC | Decatur | Georgia | 30033 | United States |
| Alexian Brothers Neurosci Inst | Elk Grove Village | Illinois | 60007 | United States |
| Louisiana Research Associates | New Orleans | Louisiana | 70114 | United States |
| Booker, J. Gary, MD, APMC | Shreveport | Louisiana | 71104-2136 | United States |
| Northern Michigan Neurology | Traverse City | Michigan | 49684 | United States |
| Hattiesburg Clinic | Hattiesburg | Mississippi | 39401 | United States |
| Millennium Psychiatric Associates, LLC | Creve Coeur | Missouri | 63141 | United States |
| Memory Enhancement Center of America, Inc. | Eatontown | New Jersey | 07724 | United States |
| Albuquerque Neuroscience Inc. | Albuquerque | New Mexico | 87109 | United States |
| New York University Medical Center;Child Study Center | New York | New York | 10016 | United States |
| Richmond Behavioral Associates | Staten Island | New York | 10312 | United States |
| Raleigh Neurology Associates | Raleigh | North Carolina | 27607-6520 | United States |
| PMG Research of Winston-Salem, LLC | Winston-Salem | North Carolina | 27103 | United States |
| Lynn Health Science Institute | Oklahoma City | Oklahoma | 73112 | United States |
| Cutting Edge Research Group | Oklahoma City | Oklahoma | 73116 | United States |
| The Clinical Trial Center, LLC | Jenkintown | Pennsylvania | 19046 | United States |
| Radiant Research, Inc. | Wyomissing | Pennsylvania | 19610 | United States |
| Rhode Island Mood & Memory Research Institute | East Providence | Rhode Island | 02914 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Alzheimer's Research & Clinical Programs | Charleston | South Carolina | 29425 | United States |
| University of North Texas Health Science Center | Fort Worth | Texas | 76107 | United States |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | 2010 | Australia |
| Central Coast Neurosciences Research | Erina | New South Wales | 2250 | Australia |
| Southern Neurology | Kogarah | New South Wales | 2217 | Australia |
| Queen Elizabeth Hospital | Woodville | South Australia | 5011 | Australia |
| Box Hill Hospital; Eastern Clinical Research Unit | Box Hill | Victoria | 3128 | Australia |
| A.G.Mander Pty Ltd | Geelong | Victoria | 3220 | Australia |
| Heidelberg Repatriation Hospital | Heidelberg | Victoria | 3084 | Australia |
| Hollywood Specialist Centre | Nedlands | Western Australia | 6009 | Australia |
| Neurodegenerative Disorders Research | Subiaco | Western Australia | 6008 | Australia |
| The Medical Arts Health Research Group | Powell River | British Columbia | V8A 3B6 | Canada |
| Vancouver Hospital - UBC Hospital Site | Vancouver | British Columbia | V6T 2B5 | Canada |
| Vancouver Island Health Authority | Victoria | British Columbia | V8R 1J8 | Canada |
| Capitol District Health Authority | Halilfax | Nova Scotia | B3H 2E1 | Canada |
| True North Clinical Research Kentville | Kentville | Nova Scotia | B4N 4K9 | Canada |
| Jbn Medical Diagnostic Services Inc. | Burlington | Ontario | L7M 4Y1 | Canada |
| Bruyere Continuing Care | Ottawa | Ontario | K1N 5C8 | Canada |
| Ingram, Jennifer MD | Peterborough | Ontario | K9H 3S1 | Canada |
| Toronto Memory Program (Neurology Research Inc.) | Toronto | Ontario | M3B 2S7 | Canada |
| The Centre for Memory and Aging | Toronto | Ontario | M4G 3E8 | Canada |
| Toronto Sunnybrook Hospital | Toronto | Ontario | M4N 3M5 | Canada |
| Recherches Neuro-Hippocame | Gatineau | Quebec | J8T 8J1 | Canada |
| Clinique Neuro Rive-Sud | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Institut Universitaire de gériatrie de Sherbrooke; Service de gériatrie/pavillon Argyll | Sherbrooke | Quebec | J1J 3H5 | Canada |
| McGill Univeristy; Douglas Mental Health University Institute; Neurological and Psychiatric | Verdun | Quebec | H4H 1R3 | Canada |
| CHU de Quebec - Hôpital de l' Enfant Jésus | Québec | G1J 1Z4 | Canada |
| NEUROHK s.r.o. | Choceň | 565 01 | Czechia |
| P-P Klinika | Kladno | 272 80 | Czechia |
| Supervize s.r.o. | Kutna Hora - Vnitrni Mesto | 284 01 | Czechia |
| Clintrial,s.r.o. | Prague | 100 00 | Czechia |
| AD71 s.r.o. | Prague | 102 00 | Czechia |
| Psychiatry Trial s.r.o. | Prague | 158 00 | Czechia |
| Neurologicka ambulance | Prague | 16000 | Czechia |
| FORBELI s.r.o. | Prague | 165 00 | Czechia |
| Nemocnice Na Bulovce | Prague | 180 01 | Czechia |
| Thomayerova nemocnice | Praha 4 - Krc | 140 59 | Czechia |
| Centre Hospitalier de la côte Basque | Bayonne | 64109 | France |
| Hopital Neurologique Pierre Wertheimer | Bron | 69500 | France |
| Hopital Nord Laënnec - CHU Nantes | Nantes | 44093 | France |
| Hopital Cimiez; CMRR | Nice | 06003 | France |
| Hôpital Lariboisière | Paris | 75475 | France |
| Groupe Hospitalier Sud - Hôpital Xavier Arnozan | Pessac | 33604 | France |
| Hôpital Maison Blanche | Reims | 51092 | France |
| CHU Rennes - Hopital Hôtel Dieu | Rennes | 35064 | France |
| CHU Toulouse - La Grave | Toulouse | 31059 | France |
| CHU Tours - Hôpital Bretonneau | Tours | 37044 | France |
| Hôpital de Brabois Adultes | Vandœuvre-lès-Nancy | 54511 | France |
| Hopital des Charpennes | Villeurbanne | 69100 | France |
| Gemeinschaftspraxis | Ellwangen | 73479 | Germany |
| Henriettenstiftung Hannover | Hanover | 30559 | Germany |
| ISPG - Institut fuer Studien zur Psychischen Gesundheit | Mannheim | 68165 | Germany |
| Klinikum rechts der Isar der Technischen Universität München | München | 81675 | Germany |
| Zentrum f. Neurologisch- Psychiatrische Studien und Begutachtung | Siegen | 57072 | Germany |
| Nuovo Ospedale Civile S.Agostino - Estense | Modena | Emilia-Romagna | 41126 | Italy |
| Policlinico Universitario Agostino Gemelli; Farmacia | Rome | Lazio | 00168 | Italy |
| Fondazione Santa Lucia IRCCS | Rome | Lazio | 00179 | Italy |
| Umberto I Policlinico di Roma-Università di Roma La Sapienza | Rome | Lazio | 00185 | Italy |
| Ente Ospedaliero Ospedali Galliera | Genoa | Liguria | 16128 | Italy |
| Università degli Studi di Genova | Genoa | Liguria | 16132 | Italy |
| Azienda Ospedaliero Universitaria Pisana; Uff. Sperim. Clin. U.O. Farmaceutica | Pisa | Tuscany | 56126 | Italy |
| Università degli studi di Perugia | Perugia | Umbria | 06126 | Italy |
| Podlaskie Centrum Psychogeriatrii | Bialystok | 15-732 | Poland |
| Uniwersyteckie Centrum Kliniczne | Gdansk | 80-214 | Poland |
| Specjal. Praktyka Lekarska; Prof. Grzegorz Opala | Katowice | 40-588 | Poland |
| Centrum Medyczne Dendryt | Katowice | 40-684 | Poland |
| NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partn. Lek | Poznan | 61-289 | Poland |
| NZOZ Syntonia | Pruszcz Gdański | 83-000 | Poland |
| NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog | Sopot | 81-717 | Poland |
| mMED Maciej Czarnecki | Warsaw | 01-697 | Poland |
| Instytut Psychiatrii i Neurologii | Warsaw | 02-957 | Poland |
| Dong-A University Hospital | Busan | 49201 | South Korea |
| Seoul National University Bundang Hospital | Gyeonggi-do | 13620 | South Korea |
| Ajou University Hospital | Gyeonggi-do | 443-380 | South Korea |
| Inha University Hospital; Pulmonary Medicine | Incheon | 400-711 | South Korea |
| Kyung Hee University Hospital | Seoul | 02447 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Konkuk University Medical Center | Seoul | 05030 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| Hospital General Universitario de Elche; Servicio de Farmacia | Elche | Alicante | 03203 | Spain |
| Fundació ACE | BArcelon | Barcelona | 08034 | Spain |
| Hospital General De Catalunya; Servicio de Neurologia | Sant Cugat del Vallès | Barcelona | 8195 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Virgen del Puerto | Plasencia | Palencia | 10600 | Spain |
| Hospital Universitario Virgen Macarena | Seville | Sevilla | 41071 | Spain |
| CAE Oroitu | Barakaldo | Vizcaya | 48903 | Spain |
| Hospital Perpetuo Socorro, Servicio de Geriatria | Albacete | 2006 | Spain |
| Hospital de la Santa Creu i Sant Pau | Barcelona | 08041 | Spain |
| Hospital Universitario Ramón y Cajal | Madrid | 28034 | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Skanes Universitetssjukhus, Malmo Skanes Universitetssjukhus, Malmo | Malmö | 205 02 | Sweden |
| Karolinska Universitetssjukhuset Huddinge | Stockholm | 171 64 | Sweden |
| Cognitive Treatment & Research Unit | Crowborough | TN6 1HB | United Kingdom |
| Ninewells Hospital | Dundee | DD12 9SY | United Kingdom |
| Glasgow Memory Clinic | Glasgow | G20 0XA | United Kingdom |
| West London Cognitive Disorders Treatment and Research Unit; Lakeside Metal Health Unit | Isleworth | TW7 6FY | United Kingdom |
| Institute of Psychiatry | London | SE5 8AF | United Kingdom |
| Norwich Medical School | Norwich | NR4 7UY | United Kingdom |
| Derriford Hospital | Plymouth | PL6 8DH | United Kingdom |
| Memory Service North | Sheffield | S35 8QS | United Kingdom |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C000614721 | sembragiline |
| D000077265 | Donepezil |
| D008559 | Memantine |
| D000068836 | Rivastigmine |
| D005702 | Galantamine |
| ID | Term |
|---|---|
| D007189 | Indans |
| D007192 | Indenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D000547 | Amantadine |
| D000218 | Adamantane |
| D001952 | Bridged-Ring Compounds |
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D047151 | Amaryllidaceae Alkaloids |
| D000470 | Alkaloids |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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