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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-004012-13 |
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This 4 arm study will assess the efficacy and safety of RO5313534 (MEM3454) versus placebo added to donepezil, in patients with mild to moderate Alzheimer's disease. Following a screening period, patients will be randomized to one of 4 treatments (placebo, or RO5313534 1mg, 5mg or 15mg po daily) with background therapy of donepezil (5mg or 10mg).The anticipated time on study treatment is 6 months, and the target sample size is 100-500 individuals.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator |
| |
| RO5313534 15mg | Experimental |
| |
| RO5313534 1mg | Experimental |
| |
| RO5313534 5mg | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | po daily for 24 weeks |
| |
| RO5313534 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| CANTAB tests, MMSE total score, ADCS CGIC, Behave-AD-FW, ADCS-ADL, Zarit Burden interview | At intervals up to week 24, then at week 28 | |
| AEs, lab parameters, suicidal risk, concomitant medications, physical and neurological examinations. | At intervals to week 24, then at week 28 |
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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 |
|---|---|---|---|---|---|---|
| Orange | California | 92868 | United States | |||
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| Drug |
1mg po daily for 24 weeks |
|
| RO5313534 | Drug | 5mg po daily for 24 weeks |
|
| RO5313534 | Drug | 15mg po daily for 24 weeks |
|
| Torrance |
| California |
| 90502 |
| United States |
| Norwalk | Connecticut | 06851 | United States |
| Delray Beach | Florida | 33445 | United States |
| Fort Myers | Florida | 33912 | United States |
| Maitland | Florida | 32751 | United States |
| Tampa | Florida | 33613-4706 | United States |
| Tampa | Florida | 33613 | United States |
| Paducah | Kentucky | 42003 | United States |
| Kalamazoo | Michigan | 49048 | United States |
| Creve Coeur | Missouri | 63141 | United States |
| Eatontown | New Jersey | 07724 | United States |
| Albuquerque | New Mexico | 87109 | United States |
| White Plains | New York | 10605 | United States |
| Portland | Oregon | 97210 | United States |
| Buenos Aires | C1090AAH | Argentina |
| Buenos Aires | C1425AGC | Argentina |
| Buenos Aires | C1431FWO | Argentina |
| Caba | C1126AAB | Argentina |
| Hornsby | New South Wales | 2077 | Australia |
| Chermside | Queensland | 4032 | Australia |
| Woodville | South Australia | 5011 | Australia |
| Medicine Hat | Alberta | T1A-4C2 | Canada |
| Vancouver | British Columbia | V6T 2B5 | Canada |
| Kingston | Ontario | K7L 5G2 | Canada |
| London | Ontario | N6C 5J1 | Canada |
| Ottawa | Ontario | K1N 5C8 | Canada |
| Peterborough | Ontario | K9H 2P4 | Canada |
| Toronto | Ontario | M3B 2S7 | Canada |
| Toronto | Ontario | M4N 3M5 | Canada |
| Montreal | Quebec | H3T 1E2 | Canada |
| Verdun | Quebec | H4H 1R3 | Canada |
| Regina | Saskatchewan | S4T 7T1 | Canada |
| Montpellier | 34295 | France |
| Nice | 06003 | France |
| Saint-Herblain | 44800 | France |
| Toulouse | 31059 | France |
| Günzburg | 89312 | Germany |
| Leipzig | 04107 | Germany |
| München | 80331 | Germany |
| Nuremberg | 90402 | Germany |
| Naples | Campania | 80131 | Italy |
| Castellanza | Lombardy | 21053 | Italy |
| Milan | Lombardy | 20122 | Italy |
| Milan | Lombardy | 20132 | Italy |
| Aguascalientes | 20127 | Mexico |
| Guadalajara | 44610 | Mexico |
| Monterrey | 64460 | Mexico |
| Saltillo | 25000 | Mexico |
| Gdansk | 80-282 | Poland |
| Leszno | 64-100 | Poland |
| Torun | 87-100 | Poland |
| Warsaw | 02-097 | Poland |
| Bucharest | 041914 | Romania |
| Bucharest | Sect 4 | Romania |
| Bratislava | 825 56 | Slovakia |
| Michalovce | 071 01 | Slovakia |
| Barcelona | Barcelona | 08003 | Spain |
| BArcelon | Barcelona | 08034 | Spain |
| Salt | Girona | 17090 | Spain |
| Madrid | Madrid | 28034 | Spain |
| Málaga | Malaga | 29010 | Spain |
| Barakaldo | Vizcaya | 48903 | Spain |
| Blackpool | FY20JH | United Kingdom |
| Bradford | BD30DQ | United Kingdom |
| Glasgow | G20 0XA | United Kingdom |
| Southampton | SO30 3JB | 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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