A Study of RO5313534 as Add-on to Donepezil Treatment in Patients With Mild to Moderate Alzheimer's Disease

NCT00884507 | Completed Phase 2

• 2 other identifiers: WN220182008-004012-13
• Study Type: interventional
• Target: 389
• Locations: 13 countries
• Sites: 67

Brief Summary

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog) score

  Week 24

Secondary Outcomes (2)

• 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

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Drug: Placebo

RO5313534 15mg

EXPERIMENTAL

Drug: RO5313534

RO5313534 1mg

EXPERIMENTAL

Drug: RO5313534

RO5313534 5mg

EXPERIMENTAL

Drug: RO5313534

Interventions

Placebo DRUG

po daily for 24 weeks

Placebo

RO5313534 DRUG

1mg po daily for 24 weeks

RO5313534 1mg

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adult patients, \>/=50 years of age;
• probable Alzheimer's disease;
• MMSE score at screening of 13-22;
• under stable donepezil treatment given at a fixed dose of 5 or 10mg daily for \>=4 months prior to baseline;
• not requiring nursing home care, but looked after by a caregiver/carer.

You may not qualify if:

• dementia due to condition other than Alzheimer's disease;
• other significant neurological disorder;
• untreated/non-stabilized major depressive disorder;
• bipolar disorder, schizophrenia, or any other serious psychiatric condition.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (67)

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Orange, California, 92868, United States

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Torrance, California, 90502, United States

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Norwalk, Connecticut, 06851, United States

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Delray Beach, Florida, 33445, United States

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Fort Myers, Florida, 33912, United States

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Maitland, Florida, 32751, United States

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Tampa, Florida, 33613-4706, United States

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Tampa, Florida, 33613, United States

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Paducah, Kentucky, 42003, United States

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Kalamazoo, Michigan, 49048, United States

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Creve Coeur, Missouri, 63141, United States

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Eatontown, New Jersey, 07724, United States

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Albuquerque, New Mexico, 87109, United States

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White Plains, New York, 10605, United States

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Portland, Oregon, 97210, United States

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Buenos Aires, C1090AAH, Argentina

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Buenos Aires, C1425AGC, Argentina

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Buenos Aires, C1431FWO, Argentina

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Caba, C1126AAB, Argentina

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Hornsby, New South Wales, 2077, Australia

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Chermside, Queensland, 4032, Australia

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Woodville, South Australia, 5011, Australia

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Medicine Hat, Alberta, T1A-4C2, Canada

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Vancouver, British Columbia, V6T 2B5, Canada

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Kingston, Ontario, K7L 5G2, Canada

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London, Ontario, N6C 5J1, Canada

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Ottawa, Ontario, K1N 5C8, Canada

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Peterborough, Ontario, K9H 2P4, Canada

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Toronto, Ontario, M3B 2S7, Canada

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Toronto, Ontario, M4N 3M5, Canada

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Montreal, Quebec, H3T 1E2, Canada

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Verdun, Quebec, H4H 1R3, Canada

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Regina, Saskatchewan, S4T 7T1, Canada

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Montpellier, 34295, France

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Nice, 06003, France

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Saint-Herblain, 44800, France

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Toulouse, 31059, France

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Günzburg, 89312, Germany

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Leipzig, 04107, Germany

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München, 80331, Germany

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Nuremberg, 90402, Germany

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Napoli, Campania, 80131, Italy

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Castellanza, Lombardy, 21053, Italy

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Milan, Lombardy, 20122, Italy

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Milan, Lombardy, 20132, Italy

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Aguascalientes, 20127, Mexico

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Guadalajara, 44610, Mexico

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Monterrey, 64460, Mexico

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Saltillo, 25000, Mexico

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Gdansk, 80-282, Poland

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Leszno, 64-100, Poland

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Torun, 87-100, Poland

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Warsaw, 02-097, Poland

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Bucharest, 041914, Romania

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Bucharest, Sect 4, Romania

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Bratislava, 825 56, Slovakia

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Michalovce, 071 01, Slovakia

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Barcelona, Barcelona, 08003, Spain

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BArcelon, Barcelona, 08034, Spain

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Salt, Girona, 17090, Spain

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Madrid, Madrid, 28034, Spain

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Málaga, Malaga, 29010, Spain

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Barakaldo, Vizcaya, 48903, Spain

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Blackpool, FY20JH, United Kingdom

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Bradford, BD30DQ, United Kingdom

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Glasgow, G20 0XA, United Kingdom

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Southampton, SO30 3JB, United Kingdom

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MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2009
• First Posted: April 20, 2009
• Study Start: May 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

AU (3); CA (11); IT (4); DE (4); ME (4); AR (4); PL (4); SL (2); GB (4); ES (6); RO (2); FR (4); US (15)